Document And Entity Information
Document And Entity Information | 12 Months Ended |
Dec. 31, 2022 shares | |
Document Information Line Items | |
Entity Registrant Name | Kamada Ltd. |
Trading Symbol | KMDA |
Document Type | 20-F |
Current Fiscal Year End Date | --12-31 |
Entity Common Stock, Shares Outstanding | 44,832,843 |
Amendment Flag | false |
Entity Central Index Key | 0001567529 |
Entity Current Reporting Status | Yes |
Entity Voluntary Filers | No |
Entity Filer Category | Accelerated Filer |
Entity Well-known Seasoned Issuer | No |
Document Period End Date | Dec. 31, 2022 |
Document Fiscal Year Focus | 2022 |
Document Fiscal Period Focus | FY |
Entity Emerging Growth Company | false |
Entity Shell Company | false |
ICFR Auditor Attestation Flag | true |
Document Registration Statement | false |
Document Annual Report | true |
Document Transition Report | false |
Document Shell Company Report | false |
Entity File Number | 001-35948 |
Entity Incorporation, State or Country Code | L3 |
Entity Address, Address Line One | 2 Holzman St |
Entity Address, Address Line Two | Science Park P.O Box 4081 |
Entity Address, City or Town | Rehovot |
Entity Address, Postal Zip Code | 7670402 |
Entity Address, Country | IL |
Title of 12(b) Security | Ordinary Shares, par value NIS 1.00 each |
Security Exchange Name | NASDAQ |
Entity Interactive Data Current | Yes |
Document Accounting Standard | International Financial Reporting Standards |
Auditor Firm ID | 1281 |
Auditor Name | KOST FORER GABBAY & KASIERER |
Auditor Location | Tel-Aviv, Israel |
Business Contact | |
Document Information Line Items | |
Entity Address, Address Line One | 2 Holzman St |
Entity Address, Address Line Two | Science Park |
Entity Address, City or Town | Rehovot |
Entity Address, Postal Zip Code | 7670402 |
Entity Address, Country | IL |
Contact Personnel Name | Amir London |
City Area Code | 972 |
Local Phone Number | 8 9406472 |
Consolidated Statements of Fina
Consolidated Statements of Financial Position - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current Assets | ||
Cash and cash equivalents | $ 34,258 | $ 18,587 |
Trade receivables, net | 27,252 | 35,162 |
Other accounts receivables | 8,710 | 8,872 |
Inventories | 68,785 | 67,423 |
Total Current Assets | 139,005 | 130,044 |
Non-Current Assets | ||
Property, plant and equipment, net | 26,157 | 26,307 |
Right-of-use assets | 2,568 | 3,092 |
Intangible assets, Goodwill and other long-term assets | 147,072 | 153,663 |
Contract asset | 7,577 | 5,561 |
Total Non-Current Assets | 183,374 | 188,623 |
Total Assets | 322,379 | 318,667 |
Current Liabilities | ||
Current maturities of bank loans | 4,444 | 2,631 |
Current maturities of lease liabilities | 1,016 | 1,154 |
Current maturities of other long term liabilities | 29,708 | 17,986 |
Trade payables | 32,917 | 25,104 |
Other accounts payables | 7,585 | 7,142 |
Deferred revenues | 35 | 40 |
Total Current Liabilities | 75,705 | 54,057 |
Non-Current Liabilities | ||
Bank loans | 12,963 | 17,407 |
Lease liabilities | 2,177 | 3,160 |
Contingent consideration | 17,534 | 21,995 |
Other long-term liabilities | 37,308 | 43,929 |
Deferred revenues | 15 | |
Employee benefit liabilities, net | 672 | 1,280 |
Total Non-Current Liabilities | 70,654 | 87,786 |
Ordinary shares | 11,734 | 11,725 |
Additional paid in capital net | 210,495 | 210,204 |
Capital reserve due to translation to presentation currency | (3,490) | (3,490) |
Capital reserve from hedges | (88) | 54 |
Capital reserve from share-based payments | 5,505 | 4,643 |
Capital reserve from employee benefits | 348 | (149) |
Accumulated deficit | (48,484) | (46,163) |
Total Shareholder’s Equity | 176,020 | 176,824 |
Total Liabilities and Shareholder’s Equity | $ 322,379 | $ 318,667 |
Consolidated Statements of Prof
Consolidated Statements of Profit or Loss and Other Comprehensive Income - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Revenues from proprietary products | $ 102,598 | $ 75,521 | $ 100,916 |
Revenues from distribution | 26,741 | 28,121 | 32,330 |
Total revenues | 129,339 | 103,642 | 133,246 |
Cost of revenues from proprietary products | 58,229 | 48,194 | 57,750 |
Cost of revenues from distribution | 24,407 | 25,120 | 27,944 |
Total cost of revenues | 82,636 | 73,314 | 85,694 |
Gross profit | 46,703 | 30,328 | 47,552 |
Research and development expenses | 13,172 | 11,357 | 13,609 |
Selling and marketing expenses | 15,284 | 6,278 | 4,518 |
General and administrative expenses | 12,803 | 12,636 | 10,139 |
Other expense | 912 | 753 | 49 |
Operating income | 4,532 | (696) | 19,237 |
Financial income | 91 | 295 | 1,027 |
Income (expenses) in respect of securities measured at fair value, net | 102 | ||
Income (expenses) in respect of currency exchange differences and derivatives instruments, net | 298 | (207) | (1,535) |
Revaluation of long-term liabilities | (6,266) | (994) | |
Financial expense | (914) | (283) | (266) |
Income before tax on income | (2,259) | (1,885) | 18,565 |
Taxes on income | 62 | 345 | 1,425 |
Net Income (Loss) | (2,321) | (2,230) | 17,140 |
Other Comprehensive Income: | |||
Gain (loss) from securities measured at fair value through other comprehensive income | (188) | ||
Gain (loss) on cash flow hedges | (776) | 876 | |
Net amounts transferred to the statement of profit or loss for cash flow hedges | 634 | (303) | (528) |
Items that will not be reclassified to profit or loss in subsequent periods: | |||
Remeasurement gain (loss) from defined benefit plan | 497 | 171 | 64 |
Tax effect | 19 | ||
Total comprehensive income (loss) | $ (1,966) | $ (2,362) | $ 17,383 |
Basic net earnings (loss) per share (in Dollars per share) | $ (0.05) | $ (0.05) | $ 0.39 |
Diluted net earnings per (loss) share (in Dollars per share) | $ (0.05) | $ (0.05) | $ 0.38 |
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, 2019 | $ 10,425 | $ 180,819 | $ 145 | $ (3,490) | $ 8 | $ 8,844 | $ (359) | $ (61,073) | $ 135,319 |
Net income | 17,140 | 17,140 | |||||||
Other comprehensive income (loss) | (188) | 348 | 64 | 224 | |||||
Tax effect | 43 | 1 | (25) | 19 | |||||
Total comprehensive income (loss) | (145) | 349 | 39 | 17,140 | 17,383 | ||||
Issuance of shares | 1,217 | 23,678 | 24,895 | ||||||
Exercise and forfeiture of share-based payment into shares | 64 | 5,263 | (5,263) | 64 | |||||
Cost of share-based payment | 977 | 977 | |||||||
Balance at Dec. 31, 2020 | 11,706 | 209,760 | (3,490) | 357 | 4,558 | (320) | (43,933) | 178,638 | |
Net income | (2,230) | (2,230) | |||||||
Other comprehensive income (loss) | (303) | 171 | (132) | ||||||
Total comprehensive income (loss) | (303) | 171 | (2,230) | (2,362) | |||||
Issuance of shares | |||||||||
Exercise and forfeiture of share-based payment into shares | 19 | 444 | (444) | 19 | |||||
Cost of share-based payment | 529 | 529 | |||||||
Balance at Dec. 31, 2021 | 11,725 | 210,204 | (3,490) | 54 | 4,643 | (149) | (46,163) | 176,824 | |
Net income | (2,321) | (2,321) | |||||||
Other comprehensive income (loss) | (142) | 497 | 355 | ||||||
Total comprehensive income (loss) | (142) | 497 | (2,321) | (1,966) | |||||
Exercise and forfeiture of share-based payment into shares | 9 | 291 | (291) | 9 | |||||
Cost of share-based payment | 1,153 | 1,153 | |||||||
Balance at Dec. 31, 2022 | $ 11,734 | $ 210,495 | $ (3,490) | $ (88) | $ 5,505 | $ 348 | $ (48,484) | $ 176,020 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Cash Flows from Operating Activities | |||
Net (loss) income | $ (2,321) | $ (2,230) | $ 17,140 |
Adjustments to the profit or loss items: | |||
Depreciation and amortization | 12,155 | 5,609 | 4,897 |
Financial expense (income), net | 6,791 | 1,189 | 672 |
Cost of share-based payment | 1,153 | 529 | 977 |
Taxes on income | 62 | 345 | 1,425 |
(Gain) loss from sale of property and equipment | (7) | ||
Change in employee benefit liabilities, net | (111) | 45 | 201 |
Adjustments to the profit or loss items | 20,050 | 7,717 | 8,165 |
Changes in asset and liability items: | |||
Decrease(increase) in trade receivables, net | 7,603 | (12,861) | 1,332 |
Decrease (increase) in other accounts receivables | (578) | (1,634) | 115 |
Decrease (increase) in inventories | (1,361) | (2,373) | 1,157 |
Decrease (increase) in deferred expenses | (1,340) | (6,883) | (3,085) |
Increase (decrease) in trade payables | 7,055 | 7,917 | (9,560) |
Increase (decrease) in other accounts payables | 290 | (392) | 1,736 |
Increase (decrease) in deferred revenues | (20) | 1,815 | 1,204 |
Total Changes in asset and liability | 11,649 | (14,411) | (7,101) |
Cash paid during the year for: | |||
Interest paid | (853) | (228) | (209) |
Interest received | 97 | 375 | 1,211 |
Taxes paid | (36) | (42) | (101) |
Cash received (paid) during the year | (792) | 105 | 901 |
Net cash (used in) provided by operating activities | 28,586 | (8,819) | 19,105 |
Cash Flows from Investing Activities | |||
Investment in short term investments, net | 39,083 | (7,646) | |
Purchase of property and equipment and intangible assets | (3,784) | (3,730) | (5,488) |
Business combination | (96,403) | ||
Proceeds from sale of property and equipment | 7 | ||
Net cash used in investing activities | (3,784) | (61,050) | (13,127) |
Cash Flows from Financing Activities | |||
Proceeds from exercise of share base payments | 9 | 19 | 64 |
Receipt of long-term loans | 20,000 | ||
Proceeds from issuance of ordinary shares, net | 24,895 | ||
Repayment of lease liabilities | (1,098) | (1,221) | (1,103) |
Repayment of long-term loans | (2,628) | (205) | (492) |
Repayment of other long-term liabilities | (5,626) | ||
Net cash provided by (used in) financing activities | (9,343) | 18,593 | 23,364 |
Exchange differences on balances of cash and cash equivalent | 212 | (334) | (1,807) |
Increase (decrease) in cash and cash equivalents | 15,671 | (51,610) | 27,535 |
Cash and cash equivalents at the beginning of the year | 18,587 | 70,197 | 42,662 |
Cash and cash equivalents at the end of the year | 34,258 | 18,587 | 70,197 |
Significant non-cash transactions | |||
Right-of-use asset recognized with corresponding lease liability | 551 | 845 | 539 |
Purchase of property and equipment | $ 618 | $ 1,001 | $ 722 |
General
General | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure of general [Abstract] | |
GENERAL | Note 1: - General a. General description of the Company and its activity Kamada Ltd. (the “Company”) is a commercial stage global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field focused on diseases of limited treatment alternatives. The Company is also advancing an innovative development pipeline targeting areas of significant unmet medical need. The Company’s strategy is focused on driving profitable growth from its significant commercial catalysts as well as its manufacturing and development expertise in the plasma-derived and biopharmaceutical fields. The Company’s commercial products portfolio includes six FDA approved plasma-derived biopharmaceutical products CYTOGAM®, KEDRAB®, WINRHO SDF®, VARIZIG®, HEPAGAM B® and GLASSIA®, as well as KAMRAB, KAMRHO (D) and two types of equine-based anti-snake venom (ASV)_products. The Company distributes its commercial products portfolio directly, and through strategic partners or third-party distributors in more than 30 countries, including the U.S., Canada, Israel, Russia, Argentina, Brazil, India, Australia and other countries in Latin America, Europe, the Middle East and Asia. The Company leverages its expertise and presence in the Israeli market to distribute, for use in Israel, more than 25 pharmaceutical products that are supplied by international manufacturers and during recent years added eleven biosimilar products to its Israeli distribution portfolio, which, subject to European Medicines Agency (EMA) and the Israeli Ministry of Health (“IL MOH”) approvals, are expected to be launched in Israel through 2028. The Company owns an FDA registered plasma collection center in Beaumont, Texas that it acquired in March 2021, which currently specializes in the collection of hyper-immune plasma used in the manufacture of KAMRHO (D). In addition to the Company’s commercial operation, it invests in research and development of new product candidates. The Company’s leading investigational product is an inhaled AAT for the treatment of AAT deficiency, for which it is continuing to progress the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. The Company has additional product candidates in early development stage. In November 2021, the Company acquired CYTOGAM, WINRHO SDF, VARIZIG and HEPGAM B from Saol Therapeutics Ltd. (“Saol”). The acquisition of this portfolio furthered the Company’s core objective to become a fully integrated specialty plasma company with strong commercial capabilities in the U.S. market, as well as to expand to new markets, mainly in the Middle East/North Africa region, and to broaden the Company’s portfolio offering in existing markets. The Company’s wholly owned U.S. subsidiary, Kamada Inc., is responsible for the commercialization of the four products in the U.S. market, including direct sales to wholesalers and local distributers. Refer to Note 5 for further details on this acquisition. The Company markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited (“Takeda”). Historically, the Company generated revenues on sales of GLASSIA, manufactured by the Company, to Takeda for further distribution in the United States. In accordance with the agreement with Takeda, the Company ceased the production and sale of GLASSIA to Takeda during 2021, and during the first quarter of 2022, Takeda began to pay the Company royalties on sales of GLASSIA manufactured by Takeda, 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. Refer to Note 19 for further details on the engagement with Takeda. 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. The Company’s ordinary shares are listed for trading on the Tel Aviv Stock Exchange and the NASDAQ Global Select Market. The Company has four wholly-owned subsidiaries – Kamada Inc., Kamada Plasma LLC (wholly owned by Kamada Inc.), KI Biopharma LLC and Kamada Ireland Limited. In addition, the Company owns 74% of Kamada Assets Ltd. (“Kamada Assets”). b. Effects of the COVID-19 Outbreak The outbreak of the COVID-19 pandemic in January 2020 and its spread throughout the world led to a global health and economic crisis and had an effect on most of the countries in the world. In response, governments around the world, including Israel, announced defensive measures such as restrictions on travel between countries, isolation measures and limitations on gatherings and movement, lockdowns, restrictions on operating private businesses and government and municipal services. Commencing in the second quarter of 2021, the Israeli economy showed an evident trend of recovery from the COVID-19 crisis, as a result of the high vaccination rate of the population, which made it possible to ease travel restrictions at various destinations around the world and to return to normal business activity. The trend of recovery continued to increase, and it appears that the effect of the COVID-19 pandemic in Israel and also in many other places around the world is fading. The Company has maintained ongoing operations with no material affect and believes that it will be able to continue operating normally also in the future. Nevertheless, there is still some level of uncertainty regarding the reinstatement of restrictions as a result of the discovery of additional variants and fear of further spread. c. Russia-Ukraine war In February 2022, the Russian army invaded Ukraine and began military operations in various areas, which resulted in civilian deaths, damage to critical infrastructures, displacement of civilians and disruption of economic activity in Ukraine. As a result of the Russian invasion of Ukraine, various countries, including the United States, Great Britain and EU countries, imposed significant economic sanctions on Russia (and in specific cases, also on Belarus). The sanctions are presently aimed at certain parties, such as Russian financial institutions, gas and oil companies, public and private entities originating from Russia, individuals connected to the Russian president, the Russian central bank, and more. As of December 31, 2022, the Company’s operations have not been materially impacted by Russia’s invasion of Ukraine, however, if additional sanctions are imposed, the Company may not be able to continue to supply its products to its Russian distributor, and even it is able to continue the supply of the products, there can be no assurance that its distributor will be able to pay the Company for such products given the actions by the Russian government to seize all international foreign currency payments. The Company’s revenues, profitability and financial condition may be affected if it is unable to continue to sell its products to the Russian market and/or is not able to collect due proceeds from previous and/or future product sales. Additionally, the impact of higher energy prices and higher prices for certain raw materials and goods and services resulting in higher inflation and disruptions to financial markets and disruptions to manufacturing and supply and distribution chains for certain raw materials and goods and services across the globe may impact the Company’s business in the future. The Company continues to assess and respond where appropriate to any direct or indirect impact that the Russian invasion of Ukraine has on the availability or pricing of the raw materials for its products, manufacturing and supply and distribution chains for its products and on the pricing and demand for its products. d. Change in interest curves and inflation expectations Since 2021, inflation rates in Israel and the world have been rising. In 2021, the rate of change in the Consumer Price Index in Israel increased, an increase that continued in 2022. In 2022, along with the worldwide rise in prices, central banks around the world decided to raise interest rates with the aim of curbing rising prices. The changes in interest rates and the rise in inflation rates had a significant effect on items in the financial statements as described in the following notes: ● Note 11 on intangible assets, with respect to impairment. ● Note 16 on employee benefits, with respect to examining the need for remeasurement of actuarial liabilities. ● Note 17 on financial risks, with respect to linkage and currency risk and hedge accounting. e. Material events in the reporting period Labor strike at the Company’s manufacturing plant at Beit Kama, Israel: On April 26, 2022, during the course of the Company’s negotiations with the Histadrut - General Federation of Labor in Israel (the “Histadrut”) and the Employees’ Committee of Kamada’s Beit Kama production facility in Israel (the “Employee’s Committee”), on the extension of a collective bargaining agreement, the Employee’s Committee elected to declare a labor strike in the Beit Kama plant. On July 15, 2022, the Company, the Employees’ Committee and the Histadrut, signed a new collective agreement detailing the understandings reached between the parties. The agreement will be effective through the end of 2029, while certain economic terms may be renegotiated by the parties following the lapse of the four-year anniversary of the agreement. As a result of execution of the agreement the labor strike ended, and the unionized employees returned to work at the Beit Kama production facility. As a result of the labor strike, the Company recorded a loss of $4,259 thousand in the cost of revenues from proprietary products which was comprised of $3,999 thousands of overhead cost charges due to lower than standard production and $260 thousands due to loss of in-process materials. On November 22, 2021, the Company entered into an Assets Purchase Agreement (the “Saol APA”) with Saol for the acquisition of a portfolio of four FDA-approved plasma-derived hyperimmune commercial products. For more information see Note 5 (b). On March 1, 2021, the Company acquired the plasma collection center and certain related rights and assets from the privately held B&PR of Beaumont, TX, USA. For more information see Note 5 (a). f. Definitions In these Financial Statements – The Company - Kamada Ltd. The Group - The Company and its subsidiaries. Subsidiary - A company which the Company has a control over (as defined in IFRS 10) and whose financial statements are consolidated with the Company’s Financial Statements. Related parties - As defined in International Accounting Standard (“IAS”) 24. USD/$ - U.S. dollar. NIS - New Israeli Shekel EUR - Euro |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
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 assets measured at fair value through other comprehensive income (“OCI”); and financial assets and liabilities (including derivatives and contingent consideration) which are presented at fair value through profit or loss. (See Note 14). 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. Business combinations and goodwill: Upon consummation of an acquisition, and for the purpose of determining the appropriate accounting treatment, the Company examines whether the transaction constitutes an acquisition of a business or assets. In determining whether a particular set of activities and assets is a business, the Company assesses whether the set of assets and activities acquired includes, at a minimum, an input and substantive process and whether the acquired set has the ability to produce outputs. The Company has an option to apply a ‘concentration test’ that permits a simplified assessment of whether an acquired set of activities and assets is not a business. The optional concentration test is met if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. Transactions in which the acquired is considered a business are accounted for as a business combination as described below. Conversely, transactions not considered as business acquisition are accounted for as acquisition of assets and liabilities. In such transactions, the cost of acquisition, which includes transaction costs, is allocated proportionately to the acquired identifiable assets and liabilities, based on their proportionate fair value on the acquisition date. In an assets acquisition, no goodwill is recognized, and no deferred taxes are recognized in respect of the temporary differences existing on the acquisition date. Business combinations are accounted for by applying the acquisition method. The cost of the acquisition is measured at the fair value of the consideration transferred on the acquisition date. Costs associated with the acquisition that were incurred by the Company in the business combination such as: finder’s fees, advisory, legal, valuation and other professional or consulting fees, other than those associated with an issue of debt or equity instruments connected to the business combination, are expensed in the period the services are received. Contingent consideration is recognized at fair value on the acquisition date and classified as a financial asset or liability in accordance with IFRS 9. Subsequent changes in the fair value of the contingent consideration are recognized in profit or loss as finance income or finance expense. If the contingent consideration is classified as an equity instrument, it is measured at fair value on the acquisition date without subsequent remeasurement. The fair value of an acquiree’s previously recognized contingent consideration assumed in connection with a business combination is recognized as financial liability on the acquisition date. Subsequently, the financial liability is measured at amortized cost, per IFRS 9. Remeasurement of the financial liability is recognized as finance income or expense in the statement of operations. Goodwill is initially measured at cost which represents the excess of the acquisition consideration over the net identifiable assets acquired and liabilities assumed. e. 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. f. 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. g. Short-term investments Short-term investments comprised of 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. h. Inventories Inventories are measured at the lower of cost and net realizable value. The cost of inventories comprises of the 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. The Company determines a standard manufacturing capacity for each quarter. To the extent the actual manufacturing capacity in a given quarter is lower than the predetermined standard, than a portion of the indirect costs which is equal to the product of the overall quarterly indirect costs multiplied by the quarterly manufacturing shortfall rate is recognized as costs of revenues 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 and development 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 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. If a contract with a customer does not meet all of the above criteria, consideration received from the customer is recognized as a liability until the criteria are met or when one of the following events occurs: the Company has no remaining obligations to transfer goods or services to the customer and any consideration promised by the customer has been received and cannot be returned; or the contract has been terminated and the consideration received from the customer cannot be refunded. 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. In order to examine whether a promise to transfer goods or services is separately identifiable, the Company examines whether it is providing a significant service of integrating the goods or services with other goods or services promised in the contract into one integrated outcome that is the purpose of the contract. Option to purchase additional goods or services An option that grants the customer the right to purchase additional goods or services constitutes a separate performance obligation in the contract only if the option grants to the customer a material right it would not have received without the original 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. In cases where the difference between the time of receiving payment and the time of transferring the goods or services to the customer is one year or less, the Company applies the practical expedient included in the standard and does not separate a significant financing component. 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. Costs to fulfill a contract: Costs incurred in fulfilling contracts or anticipated contracts with customers are recognized as an asset when the costs generate or enhance the Company’s resources that will be used in satisfying or continuing to satisfy the performance obligations in the future and are expected to be recovered. Costs to fulfill a contract comprise direct identifiable costs and indirect costs that can be directly attributed to a contract based on a reasonable allocation method. Costs to fulfill a contract are amortized on a systematic basis that is consistent with the provision of the services under the specific contract. An impairment loss in respect of capitalized costs to fulfill a contract is recognized in profit or loss when the carrying amount of the asset exceeds the remaining amount of consideration that the Company expects to receive for the goods or services to which the asset relates less the costs that relate directly to providing those goods or services and that have not been recognized as expenses. Principal or agent When another party is involved in providing goods or services to the customer, the Company examines whether the nature of its promise is a performance obligation to provide the defined goods or services itself, which means the Company is a principal and therefore recognizes revenue in the gross amount of the consideration, or to arrange that another party provide the goods or services which means the Company is an agent and therefore recognizes revenue in the amount of the net commission. The Company is a principal when it controls the promised goods or services before their transfer to the customer. Indicators that the Company controls the goods or services before their transfer to the customer include, inter alia, as follows: the Company is responsible for fulfilling the promises in the contract; the Company has inventory risk before the goods or services are transferred to the customer; and the Company has discretion in setting the prices of the goods or services. Analysis of major contracts: As of December 31, 2022, 2021 and 2020, the Company generated revenue mainly from the sale of products to strategic partners and distributors as well as from the licensing of its technology and distribution rights. In the majority of contracts, revenue recognition occurs at a point in time when control of the Company’s product is transferred to the customer, generally on delivery of the goods. The Company determines the transaction price separately for each contract with a customer taking into consideration variable prices, discounts, chargeback, rebates, etc. 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. With regards to a certain contract with its strategic partner the Company analyzed the following: The Company identified few performance obligations which include: a. Grant of a license for distribution of 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 a 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. The Company determines the transaction price and allocates the transaction price to the different performance obligation identified. 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. As of 2022, the Company also generates revenue in the form of royalty payments, due from the grant of a license for the use of the Company’s knowledge and patents. Royalty revenue is recognized when the underlying sales have occurred. Following the acquisition of CYTOGAM, WINRHO SDF, VARIZIG and HEPGAM B during November 2021, the Company, through its wholly-owned subsidiary Kamada Inc., sells these products in the U.S. market to wholesalers/distributors that redistribute/sell these products to other parties such as hospitals and pharmacies. Revenue recognition occurs at a point in time when control of the product is transferred to the wholesalers/distributors, generally on delivery of the goods. The Company’s gross sales are subject to various deductions, which are primarily composed of rebates and discounts to group purchasing organizations, government agencies, wholesalers, health insurance companies and managed healthcare organizations. These deductions represent estimates of the related obligations, requiring the use of judgment when estimating the effect of these sales deductions on gross sales for a reporting period. These adjustments are deducted from gross sales to arrive at net sales. The Company monitors the obligation for these deductions on at least a quarterly basis and records adjustments when rebate trends, rebate programs and contract terms, legislative changes, or other significant events indicate that a change in the obligation is appropriate. The following summarizes the nature of the most significant adjustments to revenues generated from the sales of these products in the U.S. market: Wholesaler chargebacks: The Company has arrangements with certain indirect customers whereby the customer is able to buy products from wholesalers at reduced prices. Fees for service: Consists of wholesaler/distributor fees. The wholesalers/distributors charge the Company fees for the redistribution of the products to hospitals and pharmacies. These fees are outlined in each wholesaler/distributor contract. The fees are invoiced to the Company monthly or quarterly by the wholesaler/distributor. The provisions for fees for service are recorded in the same period that the corresponding revenues are recognized. Deferred revenues Deferred revenues include unearned amounts received from customers not yet recognized as revenues. k. Government grants: Government grants are recognized when there is reasonable assurance that the grants will be received, and the Company will comply with the grant attached conditions. Government grants received from the Israel Innovation Authority (formerly: the Office of the Chief Scientist in Israel, “the IIA”) are recognized upon receipt as a liability if future economic benefits are expected from the research project that will result in royalty-bearing sales. A liability for the loan is first measured at fair value using a discount rate that reflects a market rate of interest. The difference between the amount of the grant received and the fair value of the liability is accounted for as a government grant and recognized as a reduction of research and development expenses. After initial recognition, the liability is measured at amortized cost using the effective interest method. Royalty payments are treated as a reduction of the liability. If no economic benefits are expected from the research activity, the grant receipts are recognized as a reduction of the related research and development expenses. In that event, the royalty obligation is treated as a contingent liability in accordance with IAS 37. l. Taxes on income Taxes on income in profit or loss comprise of current taxes, deferred taxes and taxes in respect of prior years, which 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. Uncertain tax positions A provision for uncertain tax positions, including additional tax and interest expenses, is recognized when it is more probable than not that the Company will have to use its economic resources to pay the obligation. As of December 31, 2022 and 2021, the application of IFRIC 23 did not have a material effect on the financial statements. m. Leases The Company accounts for a contract as a lease according to IFRS 16, “Leases” (“Lease Standard”), 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 the Lease 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 33 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 l |
Significant Accounting Judgment
Significant Accounting Judgments, Estimates and Assumptions Used in the Preparation of the Financial Statements | 12 Months Ended |
Dec. 31, 2022 | |
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 a. Judgments In the process of applying the significant accounting policies, the Company has made the following judgments which have the most significant effect on the amounts recognized in the financial statements: - 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 Identification of performance obligations in contracts with customers: In order to identify distinct performance obligations in a contract with a customer, the Company uses judgment when it examines whether it is providing a significant service of integrating the goods or services in the contract into one integrated outcome. Measurement of variable consideration In order to determine the transaction price, the Company estimates the amount of the variable consideration and recognizes revenue in an amount where there is a high probability that its inclusion will not result in a significant revenue reversal in the future after the uncertainty has been resolved. Existence of a significant financing component: When assessing whether a contract includes a significant financing component, the Company examines, inter alia, the expected length of time between the date it transfers the promised goods or services to the customer and the date the customer pays for these goods or services, as well as the difference and the reasons for the difference, if any, between the promised consideration and the cash selling price of the promised goods or services. Costs to fulfill a contract: Costs incurred in fulfilling contracts or anticipated contracts with customers are recognized as an asset when the costs generate or enhance the Company’s resources that will be used in satisfying or continuing to satisfy the performance obligations in the future and are expected to be recovered. Costs to fulfill a contract comprise direct identifiable costs and indirect costs that can be directly attributed to a contract based on a reasonable allocation method. Costs to fulfill a contract are amortized on a systematic basis that is consistent with the provision of the services under the specific contract. Determining how performance obligations are fulfilled: When determining that control over goods or services is transferred to the customer over time and that therefore revenue should be recognized over time, the Company relies on legal opinions, provisions of the contract and relevant provisions of the law indicating that the Company has a right to enforce fulfillment of the contract. 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 18a. - 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. - 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. - 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 it’s designated. For products without an approved indication, drug product is charged to research and development expense. - Recognition of deferred tax asset in respect of carry forward tax losses 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 22. - 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 affect the inventory value at the period end. In addition, and as part of the quarterly inventory valuation process, the Company assesses the potential effect on inventory in cases of deviations from quality standards in the manufacturing process to identify potential required inventory write offs. Such assessment is subject to Company’s judgment. - Determining cash-generating units Impairment testing for assets that cannot be tested individually are grouped together into the smallest group of assets that generates cash inflows from continuing use that are largely independent of the cash inflows of other assets or groups of assets (the “CGU”). For the purpose of goodwill impairment testing, the Company, aggregated CGUs so that the level at which impairment testing is performed reflects the lowest level at which goodwill is monitored for internal reporting purposes. When goodwill is not monitored for internal reporting purposes, it is allocated to operating segments and not to a CGU (or group of CGUs) lower in level than an operating segment. Goodwill acquired in a business combination is allocated to groups of CGUS, including CGUs existing prior to the business combination, that are expected to benefit from the synergies of the combination. Also refer to Note 11. 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 other things, 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. - 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. - Impairment of Company’s non-financial assets The carrying amounts of the Company’s non-financial assets are reviewed at each reporting date to determine whether there is any indication of impairment. If any such indication exists, then the asset’s recoverable amount is estimated. - Impairment of goodwill The Company reviews goodwill for impairment at least once a year. This requires management to make an estimate of the projected future cash flows from the continuing use of the cash-generating unit (or a group of cash-generating units) to which the goodwill is allocated and to choose a suitable discount rate for those cash flows. - Determination of Useful Life Intangible assets and property, plant and equipment are measured on initial recognition at cost including directly attributable costs. Intangible assets acquired in a business combination are measured at fair value at the acquisition date. In determining the useful life and the depreciation method, the Company assesses the period over which an asset is expected to be available for use by the Company and the pattern in which the asset’s future economic benefits are expected to be consumed by the Company. - Purchase price allocation The Company allocates the purchase price based on the identifiable assets acquired and liabilities assumed at the acquisition date. The assets and the liabilities assumed are measured at fair value on the acquisition day. Significant estimates are required to measure the fair value of the assets and liabilities recognized as a result of the business combination including, future cash flows, discount rate, volatility rate. - Determining the fair value of an unquoted financial asset or liability The fair value of unquoted financial assets or liability in Level 3 of the fair value hierarchy is determined using valuation techniques, generally using future cash flows discounted at current rates applicable for items with similar terms and risk characteristics. Changes in estimated future cash flows and estimated discount rates, after consideration of risks such as liquidity risk, credit risk and volatility, are liable to affect the fair value of these assets of liability. Contingent consideration is measured at fair value. The fair value is determined using valuation techniques and method, using future cash flows discounted. This requires management to make an estimate of the projected future cash flows. For information regarding contingent consideration, please refer to Note 5 and Note 16. |
Disclosure of New Standards in
Disclosure of New Standards in the Period Prior to their Adoption | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure of new ifrs in the period [abstract] | |
DISCLOSURE OF NEW STANDARDS IN THE PERIOD PRIOR TO THEIR ADOPTION | Note 4: - Disclosure of New Standards in the Period Prior to Their Adoption a. Amendment to IAS 1, Presentation of Financial Statements: Classification of Liabilities as Current or Non-Current Non-Current Liabilities with Covenants The Amendment, together with the subsequent amendment to IAS 1 (see hereunder) replaces certain requirements for classifying liabilities as current or non-current. According to the Amendment, a liability will be classified as non-current when the entity has the right to defer settlement for at least 12 months after the reporting period, and it “has substance” and is in existence at the end of the reporting period. According to the subsequent amendment, as published in October 2022, covenants with which the entity must comply after the reporting date do not affect classification of the liability as current or non-current. Additionally, the subsequent amendment adds disclosure requirements for liabilities subject to covenants within 12 months after the reporting date, such as disclosure regarding the nature of the covenants, the date they need to be complied with and facts and circumstances that indicate the entity may have difficulty complying with the covenants. Furthermore, the Amendment clarifies that the conversion option of a liability will affect its classification as current or non-current, other than when the conversion option is recognized as equity. The Amendment and subsequent amendment are effective for reporting periods beginning on or after January 1, 2024 with earlier application being permitted. The Amendment and subsequent amendment are applicable retrospectively, including an amendment to comparative data. The Company has not yet commenced examining the effects of applying the Amendment on the financial statements. b. Amendment to IAS 1, Presentation of Financial Statements: “Disclosure of Accounting Policies.” According to the amendment, companies must provide disclosure of their material accounting policies rather than their significant accounting policies. Pursuant to the amendment, accounting policy information is material if, when considered with other information disclosed in the financial statements, it can be reasonably be expected to influence decisions that the users of the financial statements make on the basis of those financial statements. The amendment to IAS 1 also clarifies that accounting policy information is expected to be material if, without it, the users of the financial statements would be unable to understand other material information in the financial statements. The amendment also clarifies that immaterial accounting policy information need not be disclosed. The amendment is applicable for reporting periods beginning on or after January 1, 2023. The Company is examining the effects of the amendment on the financial statements. The Company did not adopt the amendment for the financial statements for the year ended December 31, 2022. c. Amendment to IAS 12, Income Taxes: Deferred Tax related to Assets and Liabilities arising from a Single Transaction The Amendment narrows the scope of the exemption from recognizing deferred taxes as a result of temporary differences created at the initial recognition of assets and/or liabilities, so that it does not apply to transactions that give rise to equal and offsetting temporary differences. As a result, companies will need to recognize a deferred tax asset or a deferred tax liability for these temporary differences at the initial recognition of transactions that give rise to equal and offsetting temporary differences, such as lease transactions and provisions for decommissioning and restoration. The Amendment is effective for annual periods beginning on or after January 1, 2023, by amending the opening balance of the retained earnings or adjusting a different component of equity in the period the Amendment was first adopted. The Company does not expect the Amendment to have a material impact on its financial statements. |
Business Combinations
Business Combinations | 12 Months Ended |
Dec. 31, 2022 | |
Business Combinations [Abstract] | |
BUSINESS COMBINATIONS | Note 5: - Business Combinations a. Acquisition of an FDA-Licensed Plasma Collection Center On March 1, 2021, the Company entered into an Asset Purchase Agreement with the privately held B&PR of Beaumont, TX, USA, for the acquisition of the FDA registered plasma collection facility as well as certain related rights and assets. The plasma collection facility primarily specializes in the collection of hyper-immune plasma used for the Anti-D immunoglobulin, which is manufactured by the Company and distributed in international markets. The acquisition, for a total consideration of $1,614 thousand, was consummated through the Company’s wholly owned subsidiary Kamada Plasma LLC, which operates the Company’s plasma collection activity in the U.S. The Company accounted for the acquisition as a business combination. The following table details the acquisition consideration: USD in Cash paid $ 1,404 Payables for acquisition(a) 210 Total acquisition cost 1,614 (a) The acquisition consideration totaled $1,654 thousands, of which an amount of $1,404 thousands was paid at closing, and the balance of $250 thousands was paid in March 2022. The fair value of such deferred consideration was estimated at $210 as of the date of acquisition. In connection with the acquisition, the Company incurred cost of $140 thousand which included legal and other consulting fees. These costs were recorded in general and administrative expenses in the statement of profit and loss during 2020 and the first quarter of 2021. The fair value of the identifiable assets and liabilities on the acquisition date: USD in Inventories 184 Property, plant and equipment 82 Intangible assets (a) 962 1,228 Other current liability (30 ) Net identifiable assets 1,198 Goodwill arising on acquisition (b) 416 Total acquisition cost 1,614 (a) The intangible assets represent the value of the FDA license for the plasma collection facility at fair value (Level 3) at the acquisition date, based on the Greenfield Method. Under such method, the subject intangible asset is valued using a hypothetical cashflow scenario of developing an operating business in an entity that at inception only holds the subject intangible asset. In measuring the FDA license for the plasma collection facility, the Company used an appropriate discount rate of 19%. (b) The goodwill arising as part of the acquisition is attributed to the expected benefits from the synergies of the combination of the Company’s activities and those of the acquired plasma collection facility. b. Acquisition of a portfolio of four FDA-approved plasma-derived hyperimmune commercial products On November 22, 2021 (the “Acquisition Date”), the Company entered into the Saol APA for the acquisition of a portfolio of four FDA-approved plasma-derived hyperimmune commercial products. The acquisition of this portfolio furthered the Company’s core objective to become a fully integrated specialty plasma company with strong commercial capabilities in the U.S. market, as well as to expand to new markets, mainly in the Middle East/North Africa region, and to broaden the Company’s portfolio offering in existing markets. The four acquired products include: ● CYTOGAM (Cytomegalovirus Immune Globulin Intravenous [Human]) (CMV-IGIV) product indicated for the prophylaxis of cytomegalovirus disease associated with the transplantation of the kidney, lung, liver, pancreas, and heart. The product is the sole FDA approved IgG product for this indication. ● WINRHO SDF is a Rho(D) Immune Globulin Intravenous (Human) product indicated for use in clinical situations requiring an increase in platelet count to prevent excessive hemorrhage in the treatment of non-splenectomies, for Rho(D)-positive children with chronic or acute immune thrombocytopenia (ITP), adults with chronic ITP, and children and adults with ITP secondary to HIV infection. WinRho SDF is also used for suppression of Rhesus (Rh) Isoimmunization during pregnancy and other obstetric conditions in non-sensitized, Rho(D)-negative women. The product is FDA approved. ● HEPAGAM B is a hepatitis B Immune Globulin (Human) (HBIg) product indicated to both prevent hepatitis B virus (HBV) recurrence following liver transplantation in hepatitis B surface antigen positive (HBsAg- positive) patients and provide post-exposure prophylaxis. The product is FDA approved. ● VARIZIG [Varicella Zoster Immune Globulin (Human)] is a product that contains antibodies specific for the Varicella zoster virus, and it is indicated for post-exposure prophylaxis of varicella (chickenpox) in high-risk patient groups, including immunocompromised children, newborns, and pregnant women. VARIZIG is intended to reduce the severity of chickenpox infections in these patients. The U.S. Centers for Disease Control (CDC) recommends VARIZIG for postexposure prophylaxis of varicella for persons at high-risk for severe disease who lack evidence of immunity to varicella. The product is the sole FDA approved IgG product for this indication. The Company accounted for the acquisition as a business combination. The following table details the total acquisition consideration as of the Acquisition Date: USD in Cash paid at closing $ 95,000 Contingent consideration liability (a) 21,705 Deferred consideration (b) 13,788 Settlement of preexisting relationship (c) (3,786 ) Total acquisition cost 126,707 (a) Pursuant to the Saol APA, and in addition to the cash paid at closing, the Company agreed to pay up to $50,000 thousand of contingent consideration subject the achievement of sales thresholds for the period commencing on the Acquisition Date and ending on December 31, 2034. The Company may be entitled for up to $3,000 thousands credit deductible from the contingent consideration payments due for the years 2023 through 2027, subject to certain conditions as defined in the agreement between the parties. The contingent consideration totaled $21,705 thousands, which represents its fair value (Level 3) at the Acquisition Date, based on an Option Pricing Method (OPM), “Monte Carlo Simulation” model. In measuring the contingent consideration liability as of the Acquisition Date, the Company used an appropriate risk-adjusted discount rate of 10.6 % and volatility of 13.6%. The fair value of the contingent consideration was $23,534 thousand and $21,995 thousand as of December 31, 2022 and December 31, 2021, respectively. The increase in the amount of $1,539 thousand and $290 thousand for the years ended December 31, 2022 and December 31, 2021, respectively, reflects the changes in the value of the liability since the date of acquisition and was recognized as financing expenses in the statement of profit and loss. In measuring the contingent consideration liability, as of December 31, 2022 and 2021 the Company used an appropriate risk-adjusted discount rate of 11.8% and volatility of 14.21%, and an appropriate risk-adjusted discount rate of 10.5% and volatility of 10.6%, respectively. Through December 31, 2022, no payments were made by the Company on account of the contingent consideration. As of December 31, 2022, the first sales threshold was met and the first milestone payment on account of the contingent consideration is expected to be paid during the first quarter of 2023. For further information about the contingent consideration, refer to Note 14 and Note 16. (b) Pursuant to the Saol APA, the Company acquired inventory valued at $14,199 thousand which will be paid in ten quarterly installments of $1,500 thousand each or the remaining balance at the final installment. Such deferred inventory consideration totaled $13,788 thousand which represents the Fair value (Level 2) at the Acquisition Date. The interest rate used to calculate such fair value was based on the Company’s cost of debt which was estimated based on the long-term bank loan obtained to partially fund the acquisition. Through December 31, 2022, the Company made four quarterly installments on account of such inventory related debt. For further information about the deferred consideration, refer to Note 14b and Note 16. (c) In December 2019, the Company entered into a binding term-sheet for a 12-year contract manufacturing agreement with Saol to manufacture CYTOGAM. Through the Acquisition Date, the Company received a total of $3,786 thousand from Saol to partially fund the technology transfer activities required under such engagement. Such engagement was automatically terminated on the Acquisition Date, and such funds, previously accounted for as deferred revenues, were offset from the acquisition consideration as settlement of preexisting relationship. The following tables details the fair value of the identifiable assets and liabilities on the Acquisition Date: Fair value USD Inventory(a) 22,849 Intangible assets(b) 121,174 Assumed liability(c) (47,213 ) Net identifiable assets 98,810 Goodwill arising on acquisition(d) 29,897 Total acquisition cost 126,707 (a) Inventory was valued at cost which represent its fair value. (b) The following table details the intangible assets identified Fair value USD Customer Relations (1) 33,514 Intellectual property (2) 79,141 Assumed contract manufacturing agreement (3) 8,519 Total Intangible assets 121,174 (1) Customer Relations represents its fair value (Level 3) at the Acquisition Date, based on a Multi Period Excess Earnings Method (“MPEEM”). In measuring the Customer Relations, the Company used an appropriate risk-adjusted discount rate of 11% and churn rate of 5%. (2) Intellectual property represents its fair value (Level 3) at the Acquisition Date, based on a Relief from Royalties (“RFRM”) Method. In measuring the Intellectual property, the Company used an appropriate risk-adjusted discount rate of 11% and Royalties rate of 15.2%. (3) Assumed contact manufacturing agreement represents its fair value (Level 3) at the Acquisition Date, based on With and Without method. Under the With and Without method the value of an intangible asset is calculated by comparing the cash-flow in situation where the valued asset is part of the business versus the cash-flow in situation where the asset is not part of the business. The Company used an appropriate risk-adjusted discount rate of 11%. (c) Pursuant to the Saol APA, the Company assumed certain of Saol’s liabilities for the future payment of royalties (some of which are perpetual) and milestone payments to third party subject to the achievement of corresponding CYTOGAM related net sales thresholds and milestones. The fair value of such assumed liabilities at the Acquisition Date was estimated at $47,213 thousand, which was calculated based on the Option Pricing Method (OPM), Monte Carlo Simulation, and discounted cash flow using a discount rate in the range of 2.25 % and 11 % and the volatility of 10.8-14.2 %. Refer to Note 14 and Note 16 for more information. Such assumed liabilities include: ● Royalties:10 % of the annual global net sales of CYTOGAM up to $ 25,000 thousand and 5 % of net sales that are greater than $ 25,000 thousand, in perpetuity; 2% of the annual global net sales of CYTOGAM in perpetuity; and 8 % of the annual global net sales of CYTOGAM for a period of six years following the completion of the technology transfer of the manufacturing of CYTOGAM to the Company, subject to a maximum aggregate of $5,000 thousand per year and the total amount of $30,000 thousand throughout the entire six years period. ● Sales milestones: $1,500 thousand in the event that the annual net sales of CYTOGAM in the United States market exceeds $18,766 thousand during the twelve months period ending June 30, 2022 (such milestone was achieved and the payment is expected to be made during 2023); and $1,500 thousand in the event that the annual net sales of CYTOGAM in the United States market exceeds $18,390 thousand during the twelve months period ending June 30, 2023. ● Milestone: $8,500 thousand upon the receipt of FDA approval for the manufacturing of CYTOGAM at the Company’s manufacturing facility. (d) The goodwill arising on acquisition is attributed to the expected benefits from the synergies of the combination of the activities of the Company and the acquired business. As of the Acquisition Date, the Company recognized the fair value of the assets acquired and liabilities assumed in the business combination according to a provisional measurement. As of December 31, 2022, the valuation of the identifiable assets and liabilities was completed. No adjustments were required to be record. The Company incurred acquisition related cost of $1,094 thousand related mainly to legal and other consulting fees. These costs were recorded in general and administrative expenses in the statement of profit and loss during 2021. |
Cash and Cash Equivalents
Cash and Cash Equivalents | 12 Months Ended |
Dec. 31, 2022 | |
Cash and cash equivalents [abstract] | |
CASH AND CASH EQUIVALENTS | Note 6: - Cash and Cash Equivalents December 31, 2022 2021 U.S. Dollars in Cash and deposits for immediate withdrawal $ 31,411 $ 15,371 Cash equivalents in NIS deposits (1) 2,847 3,216 Total Cash and Cash Equivalents $ 34,258 $ 18,587 (1) The deposits bear interest of 2.85%-3.8% per year, as of December 31, 2022 and 0.28% per year, as of December 31, 2021. |
Trade Receivables, Net
Trade Receivables, Net | 12 Months Ended |
Dec. 31, 2022 | |
Trade Receivables, Net [Abstract] | |
TRADE RECEIVABLES, NET | Note 7: Trade Receivables, Net December 31, 2022 2021 U.S. Dollars in Open accounts: In NIS $ 9,469 $ 16,093 In USD 17,659 18,736 $ 27,128 $ 34,829 Checks receivable 124 333 $ 27,252 $ 35,162 Less allowance for doubtful accounts(1) - - Total Trade receivables, net $ 27,252 $ 35,162 (1) As of December 31, 2022 and 2021 no allowance for doubtful accounts was recognized. An analysis of past due but not impaired trade receivables with reference to reporting date: Past due trade receivables with aging of Neither Up to 30 31-60 61-90 91-120 Over 121 Total December 31, 2022 $ 22,710 $ 3,260 $ 788 $ 84 $ 7 $ 402 $ 27,252 December 31, 2021 $ 33,454 $ 593 $ 572 $ 122 $ 381 $ 40 $ 35,162 (1) Subsequent to December 31, 2022, $18,660 thousand from the past due debt was collected. The amount collected include $372 thousand out of the over 121 days. |
Other Accounts Receivables
Other Accounts Receivables | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure of other accounts receivables [abstract] | |
OTHER ACCOUNTS RECEIVABLES | Note 8: - Other Accounts Receivables December 31, 2022 2021 U.S. Dollars in Prepaid expenses $ 3,875 $ 3,992 Inventory designated for R&D activities 3,732 4,407 Government authorities 645 220 Derivatives financial instruments mainly measured at fair value through other comprehensive income - 73 Accrued income 451 173 Other 7 7 Total Other Accounts Receivables $ 8,710 $ 8,872 |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2022 | |
Inventories [Abstract] | |
INVENTORIES | Note 9: - Inventories December 31, 2022 2021 U.S. Dollars in Finished products $ 30,429 $ 36,270 Purchased products 4,754 6,251 Work in progress 12,276 8,082 Raw materials 21,326 16,820 Total Inventories $ 68,785 $ 67,423 (1) During the years 2022, 2021 and 2020, the Company recognized, as cost of revenues, an impairment for inventories carried at net realizable value totaled of $3,996 thousands, $2,982 thousands and $1,440 thousands, respectively. (2) The inventory balance as of December 31, 2022 includes $2,942 thousand of finished products and raw materials which were obtained as part of the business combination. Refer to Note 5b for further details |
Property, Plant and Equipment
Property, Plant and Equipment | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure of detailed information about property, plant and equipment [abstract] | |
PROPERTY, PLANT AND EQUIPMENT | Note 10: - Property, Plant And Equipment a. Composition and movement: 2022 Land and Machinery Vehicles Computers, Leasehold Total U.S. Dollars in thousands Cost Balance at January 1, 2022 $ 34,543 33,439 31 9,371 1,184 78,568 Additions 547 1,906 - 966 382 3,801 Sale and write-off - (2 ) - - - (2 ) Balance as of December 31, 2022 35,090 35,343 31 10,337 1,566 82,367 Accumulated Depreciation Balance as of January 1, 2022 21,091 23,804 23 6,808 535 52,261 Depreciation 1,063 1,691 3 1,074 120 3,951 Sale and write-off - (2 ) - - - (2 ) Balance as of December 31, 2022 22,154 25,493 26 7,882 655 56,210 Depreciated cost as of December 31, 2022 $ 12,936 9,850 5 2,455 911 26,157 (1) Including labor costs charged in 2022 to the cost of facilities, machinery, and equipment in the amount of $1,043 thousands. 2021 Land and Machinery Vehicles Computers, Leasehold Total U.S. Dollars in thousands Cost Balance at January 1, 2021 $ 33,658 31,299 31 8,112 1,139 74,239 Additions 885 2,140 - 1,260 45 4,329 Balance as of December 31, 2021 34,543 33,439 31 9,371 1,184 78,568 Accumulated Depreciation Balance as of January 1, 2021 20,049 22,110 20 5,961 420 48,560 Depreciation 1,042 1,694 3 847 115 3,701 Balance as of December 31, 2021 21,091 23,804 23 6,808 535 52,261 Depreciated cost as of December 31, 2021 $ 13,451 $ 9,635 $ 8 $ 2,563 $ 649 $ 26,307 (1) Including labor costs charged in 2021 to the cost of facilities, machinery, and equipment in the amount of $775 thousands. b. As for liens, refer to Note 19. c. Leasing rights of land from the Israel land administration. December 31, 2022 2021 U.S. Dollars in Under finance lease $ 1,119 $ 1,150 Kamada Assets Ltd., a subsidiary of the Company, capitalized leasing rights from the Israel Lands Administration for an area of 16,880 m² in Beit Kama, Israel, on which the Company’s manufacturing plant and other buildings are located. As part of a new outline which were approved during 2021, the plant area was adjusted to 14,880 m². The amount 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, Kamada Assets signed an agreement with the Israel Lands Administration to consolidate its leasing rights and extend the lease period to 2058; the lease also includes an extension option allowing the parties to extend the lease for an additional 49 years following the conclusion of the initial term. |
Intangible Assets, Goodwill and
Intangible Assets, Goodwill and Other Long Term Assets | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure of other non-current assets [abstract] | |
Intangible Assets,Goodwill and Other Long Term Assets | Note 11: - Intangible Assets, Goodwill and Other Long Term Assets December 31, 2022 2021 U.S. Dollars in thousands Intangible Assets and Goodwill 147,009 153,592 Long term pre-paid expenses 63 71 Total Other Long-Term Assets $ 147,072 $ 153,663 1. Intangible Assets: (a) Composition and movement 2022 Intellectual Customer Goodwill Other Total U.S. Dollars in thousands Cost: Balance as of January 1, 2022 80,103 33,514 30,313 10,501 154,431 Purchases 600 600 Balance as of December 31, 2022 $ 80,103 $ 33,514 $ 30,313 $ 11,101 $ 155,031 Accumulated amortization and impairment: Balance as of January 1, 2022 477 179 - 183 839 Amortization recognized in the year 5,376 1,676 - 131 7,183 Balance as of December 31, 2022 5,853 1,855 - 314 8,022 Amortized cost at December 31, 2022 $ 74,250 $ 31,659 $ 30,313 $ 10,787 $ 147,009 (1) Includes assumed contract manufacturing agreement and distribution right of certain therapeutic products to be distributed in Israel, subject to IL MOH marketing authorization. The Company was required to make certain upfront and milestone payments on account of such distribution rights. These payments are accounted for as long-term assets through obtaining IL MOH marketing authorization and will subsequently be amortized during the expected distribution right’s useful life. 2021 Intellectual Customer Goodwill Other Total U.S. Dollars in thousands Cost: Balance as of January 1, 2020 - - - 1,492 1,492 Purchases 490 490 Business combination (b) 80,103 33,514 30,313 8,519 152,449 Balance as of December 31, 2021 $ 80,103 $ 33,514 $ 30,313 $ 10,501 $ 154,431 Accumulated amortization and impairment: Balance as of January 1, 2020 - - - - - Amortization recognized in the year 477 179 - 183 839 Balance as of December 31, 2020 477 179 - 183 839 Amortized cost at December 31, 2021 $ 79,626 $ 33,335 $ 30,313 $ 10,318 $ 153,592 (b) Amortization: Amortization expenses of intangible assets are classified in statement of profit or loss as follows: Year ended December 31, 2022 2021 2020 USD in thousands Cost of goods sold 5,376 574 - Selling and marketing expenses 1,807 265 - 7,183 839 - (d) Allocation of goodwill to cash-generating units December 31, 2022 2021 U.S. Dollars in thousands Proprietary $ 30,313 30,313 The goodwill is attributed to the Proprietary Products segment, which represent the lowest level within the Company at which goodwill is monitored for internal management purposes. Impairment test of goodwill for the year ended on December 31, 2022: Impairment loss for goodwill is recognized if the recoverable amount of the goodwill is less than the carrying amount. The recoverable amount is the greater of fair value less costs of disposal, or value in use of the relevant reporting level (ie a CGU of a group of CGU’s). The Company performed an assessment for goodwill impairment for its Proprietary Products segment, which is the level at which goodwill is monitored for internal management purposes and concluded that the fair value of the Proprietary Products segment exceeds the carrying amount by approximately 20%. The carrying amount of goodwill assigned to this segment is in the amount of $30,313 thousand. When evaluating the fair value of the Proprietary Products segment, the Company used a discounted cash flow model which utilized Level 3 measures that represent unobservable inputs. Key assumptions used to determine the estimated fair value include: (a) internal cash flows forecasts for 5 years following the assessment date, including expected revenue growth, costs to produce, operating profit margins and estimated capital needs; (b) an estimated terminal value using a terminal year long-term future growth rate of -5.0% determined based on the long-term expected prospects of the reporting unit; and (c) a discount rate (post-tax) of 12.1 % which reflects the weighted-average cost of capital adjusted for the relevant risk associated with the Proprietary Products segment’s operations. Actual results may differ from those assumed in the Company’s valuation method. It is reasonably possible that the Company’s assumptions described above could change in future periods. If any of these were to vary materially from the Company’s plans, it may record impairment of goodwill allocated to this reporting unit in the future. A hypothetical decrease in the growth rate of 1% or an increase of 1% to the discount rate would have reduced the fair value of the Proprietary Products segment reporting unit by approximately $4,000 thousand and $19,000 thousands, respectively. Based on the Company’s assessment as of December 31, 2022, no goodwill was determined to be impaired. |
Trade Payables
Trade Payables | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure of trade and other payables [abstract] | |
TRADE PAYABLES | Note 12: - Trade Payables December 31, 2022 2021 U.S. Dollars in thousands Open debts mainly in USD $ 12,731 $ 7,354 Open debts in EUR 10,629 9,174 Open debts in NIS 9,557 8,576 Total Trade Payables $ 32,917 $ 25,104 |
Other Accounts Payables
Other Accounts Payables | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure Of Other Accounts Payables Explanatory [abstract] | |
OTHER ACCOUNTS PAYABLES | Note 13: - Other Accounts Payables a. Composition: December 31, 2022 2021 U.S. Dollars in thousands Employees and payroll accruals $ 6,683 $ 6,348 Government grants (b) 201 207 Derivatives financial instruments 92 - Accrued Expenses and Others 609 587 Total Other Accounts Payables 7,585 $ 7,142 b. Government grants: Presented in the statement of financial position and Profit or Loss and Other Comprehensive Income: December 31, 2022 2021 U.S. Dollars in thousands Current Assets 3 3 Current liability 201 207 Royalties paid during the year - - Expense (income) carried to profit or loss $ 29 (29 ) |
Loans and Financial Liabilities
Loans and Financial Liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure Of Borrowings Text Block Abstract | |
LOANS AND FINANCIAL LIABILITIES | Note 14: - Loans and Financial liabilities December 31, 2022 2021 U.S. Dollars in thousands Bank loans (1) 17,407 20,038 Less current maturities of bank loans 4,444 2,631 Total Long term bank loans $ 12,963 $ 17,407 1. Bank loan On November 15, 2021, the Company secured a $40,000 thousand credit facility from Bank Hapoalim, an Israeli bank. The credit facility comprised of the following: (1) A $20,000 thousand long-term loan. The loan bears an interest at a rate of SOFR (Secured Overnight Financing Rate) +2.18% and is payable over 54 equal monthly installments commencing June 16, 2022; and (2) A $20,000 thousand short-term revolving credit facility. The credit facility bears an interest at a rate of SOFR +1.75%, or a commitment fee of 0.2% calculated over the unutilized balance of the facility. As of December 31, 2022, the Company did not utilize such facility. The credit facility was in effect for an initial period of 12 months, and effective as of January 1, 2023, the credit facility was amended such that the $20 million short-term revolving credit facility was reduced to a NIS 35 million (approx. $10 million) credit facility and the credit facility was extended for an additional period of 12 months. Borrowings under the amended credit facility accrue interest at a rate of PRIME + 0.55 and are repayable no later than 12 months from the date advanced. We are required to pay an annual fee of 0.275% for the Bank’s credit allocation. Pursuant to the loan and credit facility agreement, the Company is required to meet the following financial covenants for the years ending December 31, 2022, and onwards: (1) The Shareholder’s Equity shall at no time be less than 30% of the Total Assets; examined on a quarterly basis; (2) The Shareholder’s Equity shall at no time be less than $120,000 thousand; examined on a quarterly basis; (3) The ratio between:(a) the short term financial debt less current maturities of long term debt (in as much as such are included therein); and (b) the Working Capital, as such term is defined in the loan agreement, shall at no time exceed 0.8; examined on a quarterly basis; and (4) The ratio between: (a) the EBITDA as such term is defined in the loan agreement; and (b) the current maturities of long term debt to financial institutions plus out of pocket financial expenses, net, reported in the course of four consecutive quarters immediately preceding the examination date, shall not be less than 1.1 during each of the years 2022 and 2024 and not less than 1.25 in the year 2025 and onwards, examined on an annual basis. As of December 31, 2022, the Company is in compliance with the financial covenants. Bank loans borrowed prior to 2021 are payable over 60 equal monthly installments. The loans bear fixed interest rate in the range of 3.15% -3.55%. See Note 19 regarding pledge information related to the bank loans. b. Financial liabilities originated or assumed through business combinations December 31, 2022 2021 U.S. Dollars in thousands Contingent consideration (1) 23,534 21,995 Assumed liabilities (2) 61,016 61,915 Less current maturities (29,708 ) (17,986 ) Total Long term Contingent consideration and assumed liabilities $ 54,842 43,929 (1) At December 31, 2022 the fair value of the contingent consideration total $23,534 thousand. The increase in the amount of $1,539 thousands reflects the changes in the value of the liability during 2022 and was recognized as financing expenses in the statement of profit and loss. Through December 31, 2022, no payments were made by the Company on account of the contingent consideration. As of December 31, 2022, the first sales threshold was met and the first milestone payment on account of the contingent consideration is expected to be paid during the first quarter of 2023. Refer to Note 5b and Note 18 for details on the contingent consideration. (2) The assumed liabilities are measured at amortized cost. The decrease in the balance of the assumed liabilities reflects the changes in time value due to and changes in expected payments since the date of acquisition at an amount of $4,727 thousands, net of $5,626 thousands paid during 2022. The increase was recognized as financing expenses in the statement of profit and loss. Refer to Note 5 and Note 16 for details on the assumed liabilities. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
LEASES | Note 15: - Leases Leases 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 a total of ten years, such term includes a three-year extension through November 2026. 2. Vehicles: The Company leases vehicles for the use of certain of its employees. The lease term is mainly for three-year periods from several leasing entities. 3. Office equipment (i.e. printing and photocopying machines): The Company leases office equipment (i.e., printing and photocopying machines), each for a five year period. Right-of-use assets composition and changes in lease liabilities Right-of-use-assets Rented Vehicles Computers, Total Lease (1) U.S Dollars in thousands As of January 1, 2022 $ 2,165 $ 913 $ 15 $ 3,093 $ 4,314 Additions to right-of-use assets - 551 - 551 551 Termination lease - (52 ) - (52 ) (59 ) Depreciation expense (433 ) (583 ) (8 ) (1,024 ) Exchange rate differences - - - - (448 ) Repayment of lease liabilities - - - - (1,164 ) As of December 31, 2022 $ 1,732 $ 829 $ 7 $ 2,568 $ 3,193 (1) The weighted average incremental borrowing rate used to discount future lease payments in the calculation of the lease liability was in the range of 1.94%-4.6% evaluated based on credit risk, terms of the leases and other economic variables. During 2022, the Company recognized $148 thousand as interest expenses on lease liabilities. During 2022, the total cash outflow for leases was $1,164 thousand. Right-of-use-assets Rented Vehicles Computers, Total Lease (1) U.S Dollars in thousands As of January 1, 2021 $ 2,599 $ 821 $ 20 $ 3,440 $ 4,665 Additions to right -of -use assets 845 845 845 Lease termination (125 ) (125 ) (125 ) Depreciation expense (433 ) (628 ) (5 ) (1,068 ) Exchange rate differences 150 Repayment of lease liabilities (1,221 ) As of December 31, 2021 $ 2,165 $ 913 $ 15 $ 3,093 $ 4,314 (1) The weighted average incremental borrowing rate used to discount future lease payments in the calculation of the lease liability was in the range of 1.75%-4.6% evaluated based on credit risk, terms of the leases and other economic variables. During 2021, the Company recognized $253 thousand as interest expenses on lease liabilities. During 2021, the total cash outflow for leases was $1,221 thousand. Maturity analysis of the Company’s lease liabilities (including interest): As of December 31, 2022: Less than 1 to 2 2 to 3 3 to 5 6 and Total Lease liabilities (including interest) $ 1,119 $ 907 $ 732 $ 683 $ - $ 3,441 As of December 31, 2021: Less than 1 to 2 2 to 3 3 to 5 6 and Total Lease liabilities (including interest) $ 1,307 $ 1,100 $ 849 $ 1,485 $ 31 $ 4,772 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 has reasonable certainty 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, 2022 | |
Disclosure of financial instruments [abstract] | |
FINANCIAL INSTRUMENTS | Note 16: - 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, 2022 2021 U.S. Dollars in thousands Financial assets Financial assets at fair value through other comprehensive income: Cash flow hedges - 73 Total Financial assets at fair value through other comprehensive income: $ - $ 73 Financial assets at cost: Cash and cash equivalent 34,258 18,587 Total Financial assets at cost $ 34,258 $ 18,587 Total financial assets $ 34,160 $ 18,660 Financial liabilities Financial liabilities at fair value through profit or loss: Cash flow hedges 92 Contingent consideration in business combination 23,534 21,995 Foreign exchange forward contracts $ - $ - 23,626 21,995 Financial liabilities measured at amortized cost: Assumed liabilities through business combination 61,016 61,915 Bank loans 17,407 20,038 Leases 3,193 4,314 Total Financial liabilities measured at amortized cost: $ 81,616 $ 86,267 Total financial and lease liabilities $ 105,242 $ 108,262 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 utilizes derivatives to hedge certain exposures to risk. Risk management is the responsibility of the Company’s management and specifically that of the Company’s Chief Executive Officer (CEO) and 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 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, 2022 and 2021, the Company held financial derivatives intended to hedge changes in the exchange rate of the USD vs. the NIS and the EUR (see also Note 16f. below). 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, 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 and the United States. 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. 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, to the extent required, accounts for 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, 2022 and 2021 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 16f. below). d) Interest rate risk: Interest rate risk is the risk that the fair value or future cash flows of a financial instrument will fluctuate because of changes in market interest rates. The Company’s exposure to the risk of changes in market interest rates relates primarily to the Company’s long-term liabilities with floating interest. 3. Liquidity risk The table below summarizes the maturity profile of the Company’s financial liabilities based on contractual undiscounted payments: December 31, 2022 Less than 1 to 2 2 to 3 3 to 5 6 and Total Trade payables $ 32,917 - - - - 32,917 Assumed liabilities (1) 23,708 5,030 4,087 7,928 20,263 61,016 Other accounts payables 7,585 - - - - 7,585 Bank loans (including interest) 4,841 4,677 4,580 4,111 - 18,208 Lease liabilities (including interest) 1,119 907 732 683 - 3,441 $ 70,170 10,614 9,399 12,722 20,263 123,167 (1) Due the nature of the account which include infinite payments for royalties and milestones to third party the assumed liabilities reflect the discounted amount. see Note 18e December 31, 2021 Less than 1 to 2 2 to 3 3 to 5 6 and Total Trade payables $ 25,104 - - - - $ 25,104 Assumed liabilities 17,986 11,203 4,671 7,598 20,457 61,915 Other accounts payables 7,142 - - - - 7,142 Bank loans (including interest) 3,049 4,773 4,677 8,689 - 21,188 Lease liabilities (including interest) 1,307 1,100 849 1,485 31 4,772 $ 54,588 $ 17,076 $ 10,197 $ 17,772 $ 20,488 $ 120,121 Changes in liabilities arising from financing activities January 1, Payments Foreign New Business Revaluation Write off December 31, U.S. Dollars in thousands Contingent consideration (1) 21,995 - - - - 1,539 - 23,534 Assumed liabilities 61,915 (5,626 ) - - - 4,727 - 61,016 Bank loans $ 20,038 (2,628 ) (2 ) - - - - $ 17,408 Leases 4,314 (1,164 ) (448 ) 551 - - (59 ) 3,193 Total $ 108,262 $ (9,418 ) $ (450 ) $ 551 $ - $ 6,266 $ (59 ) $ 105,152 (1) The contingent consideration fair value as of December 31, 2022 was based on an Option Pricing Method (OPM), “Monte Carlo Simulation” model. In measuring the contingent consideration liability, the Company used an appropriate risk-adjusted discount rate of 11.8 % and volatility of 14.21 %. totaled $23,534 thousands. 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, 2022 2021 2022 2021 U.S. Dollars in thousands Assumed liabilities 61,016 61,915 56,946 61,915 Bank loans 17,408 20,038 17,071 19,502 Leases 3,193 4,314 3,183 4,608 Total Financial liabilities $ 81,617 $ 86,267 $ 77,200 $ 86,025 The fair value of the bank loans, leases and the assumed liabilities was based on standard pricing valuation model such as a discounted cash-flow model which considers the present value of future cash flows discounted by an 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 Level 3 (1) U.S. Dollars in thousands December 31, 2022 Derivatives instruments - (92 ) - Contingent consideration(1) - - (23,534 ) $ - $ (92 ) $ (23,534 ) Financial assets (liabilities) measured at fair value: Level 1 Level 2 Level 3 (1) U.S. Dollars in thousands December 31, 2021 Derivatives instruments - 73 - Contingent consideration(1) - - (21,995 ) $ - $ 73 $ (21,995 ) (1) For changes in Contingent liability see above During 2022 and 2021, 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, 2022 2021 U.S. Dollars in thousands Sensitivity test to changes in interest rate risk Gain (loss) from change: 1% increase in basis points of SOFR $ (13 ) $ (23 ) 1% decrease in basis points of SOFR $ 13 $ 22 Sensitivity test to changes in foreign currency: Gain (loss) from change: 5% increase in NIS $ (57 ) $ (30 ) 5% decrease in NIS $ 57 $ 30 5% increase in Euro $ (389 ) $ (450 ) 5% decrease in Euro $ 389 $ 450 e. Linkage terms of financial liabilities by groups of financial instruments pursuant to IFRS 9: December 31, 2022 2021 U.S. Dollars in thousands In NIS: Bank loans measured at amortized cost $ - $ 38 Leases measured at amortized cost 3,193 4,314 $ 3,193 $ 4,352 In USD: Contingent consideration at fair value through profit or loss 23,534 21,995 Assumed liabilities measured at amortized cost 61,016 61,915 Bank loans measured at amortized cost 17,407 20,000 $ 101,957 $ 103,910 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. 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, 2022, the fair value of the derivative instruments not designated as hedging was financial liability of $4 thousand. The open transactions for those derivatives were in an amount of $15,379 thousands. Cash flow hedges As of December 31, 2022, 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, 2022, the fair value of the derivative instruments designated as hedge accounting was an asset of $88 thousand. The open transactions for those derivatives were in an amount of $412 thousands. Cash flow hedges of the expected salaries and suppliers’ expenses as of December 31, 2022 were estimated as effective and accordingly a net unrecognized expense was recorded in other comprehensive income in the amount of $141 thousand, net. The ineffective portion were allocated to finance expense. |
Employee Benefit Liabilities, N
Employee Benefit Liabilities, Net | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure of information about defined benefit plans [abstract] | |
EMPLOYEE BENEFIT LIABILITIES, NET | Note 17: - Employee Benefit Liabilities, NET Employee benefits consist of short-term benefits and post-employment benefits. Post-employment benefits: According to the labor laws and Israeli Severance Pay Law, 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 Israeli 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 2022, 2021 and 2020 were $873 thousands, $1,023 thousands and $1,299 thousands, respectively. U.S. employees defined contribution plan: As of August 2022, the U.S. Subsidiary has a 401(k) defined contribution plan covering certain employees in the U.S. During the year ended December 31, 2022 the U.S. Subsidiary recorded expenses for matching contributions in amounts of $11 thousands. 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, 2022 2021 2020 U.S. Dollars in thousands Current service cost $ 223 $ 281 $ 264 Past service cost - 415 - Interest expenses, net 21 23 23 Total employee benefit expenses 237 716 287 Actual return on plan assets $ (25 ) $ 349 $ 35 The expenses are presented in the Statement of Comprehensive income (loss) as follows Year Ended December 31, 2022 2021 2020 U.S. Dollars in thousands Cost of revenues $ 166 $ 499 $ 195 Research and development 24 90 45 Selling and marketing 27 62 22 General and administrative 21 65 25 $ 238 $ 716 $ 287 4. The plan liabilities, net: December 31, 2022 2021 U.S. Dollars in thousands Defined benefit obligation $ 4,379 $ 5,434 Fair value of plan assets 3,707 4,154 Total liabilities, net $ 672 $ 1,280 5. Changes in the present value of defined benefit obligation 2022 2021 U.S. Dollars in thousands Balance at January 1, $ 5,434 $ 5,606 Interest costs 78 84 Current service cost 223 281 Past service cost 0 415 Benefits paid (202 ) (1,309 ) Demographic assumptions (9 ) (10 ) Financial assumptions (715 ) (33 ) Past Experience 206 149 Currency Exchange (636 ) 165 Balance at December 31, $ 4,379 $ 5,434 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 2022 2021 U.S. Dollars in thousands Balance at January 1, $ 4,154 $ 4,200 Expected return 62 62 Contributions by employer 181 189 Benefits paid (181 ) (780 ) Demographic assumptions 0 0 Financial assumptions (4 ) 0 Past Experience (20 ) 362 Currency exchange (485 ) 121 Balance at December 31, $ 3,707 $ 4,154 7. The principal assumptions underlying the defined benefit plan 2022 2021 2020 % Discount rate of the plan liability 5.10 3.1 1.8 Future salary increases 3.0 3.0 3.0 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 $110 thousands or increase by $165 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 $158 thousands or decrease by $105 thousands, respectively. |
Contingent Liabilities and Comm
Contingent Liabilities and Commitments | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure of commitments and contingent liabilities [abstract] | |
CONTINGENT LIABILITIES AND COMMITMENTS | Note 18: - Contingent Liabilities and Commitments a. On August 23, 2010, the Company entered into a 30 year 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 would 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”). Through December 31, 2021, the Company accounted for as income all of the $45 million associated with the upfront and milestone payments from Takeda pursuant to the Distribution and License Agreements as amended. On March 31, 2021, the Company entered into an amendment to the Technology License Agreement with Takeda with respect to GLASSIA. Pursuant to the amendment the Company undertook to transfer to Takeda the U.S. Biologics License Application (BLA) of the product upon completion of the transition of GLASSIA manufacturing to Takeda, in consideration for a $2 million payment from Takeda. Such amount was paid by Takeda and accounted for as income during the first quarter of 2022. During 2021 the Company terminated the production and supply of GLASSIA to Takeda and Takeda initiated its own production of GLASSIA for distribution in the Territory. Accordingly, commencing 2022, Takeda initiated royalty payments to the Company as defined above. As of December 31, 2022 the Company accountant for a total of $12.2 million from sales-based royalty income. 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 (“PARI”) in connection with a supply by PARI of a certain medical devise required for the development of the Company’s Inhaled AAT product. Pursuant to the agreement, the Company was licensed to use developments made by PARI. Furthermore, PARI 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 PARI 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, PARI 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’ obligations, mentioned above, are applicable to all indications. 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 PARI for the supply of the required quantities of controller kits and the web portal associated with PARI’s device required for the Company’s continued clinical trials with respect to the Inhaled AAT product. The CSSA is a supplement agreement to the commercialization and supply agreement and will expire upon the expiration or termination of such agreement. c. In July 2011, the Company entered into a strategic collaboration agreement with Kedrion Biopharma (“Kedrion”) for clinical development, marketing, distribution, and sales in the United States of the Company’s rabies immune globulin (Human) under the trade name KEDRAB. The product is manufactured and marketed by the Company in other countries under a different trade name KAMRAB. The Company obtained U.S marketing authorization from the FDA for KEDRAB in August 2017, and commercial 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 finalized during 2020. The cost of the study was equally shared between the parties. In April 2020, the Company entered into a binding term sheet with Kedrion for the co-development, manufacturing and distribution of a human plasma-derived Anti-SARS-CoV-2 polyclonal immunoglobulin (IgG) product as a potential treatment for COVID-19 patients. The plasma-derived Anti-SARS-CoV-2 IgG product was developed and manufactured utilizing the Company’s proprietary IgG platform technology. Pursuant to the agreed terms, Kedrion provided plasma, collected at its U.S. plasma collection centers, from donors who have recovered from the virus. The Company was responsible for product development, manufacturing, clinical development, with Kedrion’s support, and regulatory submissions. The binding term sheet remained in effect until June 30, 2021. No definitive agreement was entered to between the parties, and the Company terminated this product development program. 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 Saol to manufacture CYOTGAM. Following the execution of the required technology transfer from the current manufacturer, and pending all required FDA approvals, the Company is expected to commence commercial manufacturing of the product during 2023. As a result of the consummation of the Saol transaction as detailed below, which included the acquisition of all rights relating to CYTOGAM, the previous engagement with Saol with respect to this product expired. On November 22, 2021, the Company entered into the Saol APA for the acquisition of a portfolio of four FDA-approved plasma-derived hyperimmune commercial products - CYTOGAM, HEPAGAM B, VARIZIG AND WINRHO SDF. Under the terms of the APA, the Company paid Saol a $95 million upfront payment, and agreed to pay up to an additional $50 million of contingent consideration subject the achievement of sales thresholds for the period commencing on the Acquisition Date and ending on December 31, 2034. The Company may be entitled for up to $3 million credit deductible from the contingent consideration payments due for the years 2023 2027 In addition, the Company acquired inventory valued at $14.2 million and agreed to pay the consideration to Saol in ten quarterly installments of $1.5 million each or the remaining balance at the final installment. As part of the acquisition, the Company assumed certain of Saol’s liabilities for the future payment of royalties (some of which are perpetual) and milestone payments to third party subject to the achievement of corresponding CYTOGAM related net sales thresholds and milestones. Such assumed liabilities include: ● Royalties:10 % of the annual global net sales of CYTOGAM up to $25 million and 5 % of net sales that are greater than $25 million, in perpetuity; 2% of the annual global net sales of CYTOGAM in perpetuity; and, 8% of the annual global net sales of CYTOGAM for period of six years following the completion of the technology transfer of the manufacturing of CYTOGAM to the Company, subject to a maximum aggregate of $5 million per year and for total amount of $30 million throughout the entire six years period. ● Sales milestones: $1.5 million in the event that the annual net sales of CYTOGAM in the United States market exceeds $18.8 million during the twelve months period ending June 30, 2022; and $1.5 million in the event that the annual net sales of CYTOGAM in the United States market exceeds $18.4 million during the twelve months period ending June 30, 2023. ● Milestone: $8.5 million upon the receipt of FDA approval for the manufacturing of CYTOGAM at Company’s manufacturing facility. To partially fund the acquisition costs, the Company secured a $40 million financing facility from an Israeli bank which comprised of a $20 million five-year loan and a $20 million short-term revolving credit facility. Refer to Note 14. In connection with the acquisition, the Company entered into a transition services agreement with Saol, which defined the services and support to be provided by Saol to the Company for a defined period. As of December 31, 2022 and 2021, the Company recognized an asset in respect of costs of fulfilling contracts on the amount of $ 7,577 and $ 5,561 thousands, respectively. No amortization or impairment losses was recognized. 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 IL IMOH. Pursuant to the agreement the Company is obligated to pay Alvotech certain milestone payments, in advance of the launch of the six biosimilar in Israel. In February 2022, the agreement was extended to include two additional biosimilar products. g. On January 14, 2021, the Company entered into an agreement with undisclosed international pharmaceutical companies to commercialize one of the distribution products, in Israel. Pursuant to the agreement the Company is obligate to pay royalties in the amount of 24% out of the net revenue from the sale of the product in the Israeli market. h. During May 2022, the Company terminated a distribution agreement with a third-party engaged to distribute the Company’s proprietary products in Russia and Ukraine (the “Distributor”), and a power of attorney granted, in connection with such distribution agreement, to an affiliate of the Distributor (the “Affiliate). On July 18, 2022, the Affiliate notified the Company of the filing of a request for a non-binding conciliation hearing with the Court in Geneva relying on the terminated power of attorney and seeking damages for the alleged inability to sell the remaining product inventory previously acquired from the Company and compensation for the lost customer base. The conciliation hearing is scheduled for March 17, 2023. At this stage, it is not possible to assess the prospects and scope of any claims against the Company and any potential liabilities as such conciliation request is an initial procedure and the claims are not fully substantiated. |
Guarantees and Charges
Guarantees and Charges | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure of guarantees and charges [abstract] | |
GUARANTEES AND CHARGES | Note 19: - Guarantees and Charges a. The Company provided a bank guarantees in the amount of $ 308 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. In connection with the Saol APA, the Company secured a debt facility from an Israeli bank (see Note 14) pursuant to which, the Company undertook not to create any first ranking floating charge over all or materially all of its property and assets in favor of any third party unless certain terms, as defined in the loan agreement, have been satisfied. |
Equity
Equity | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure of classes of share capital [abstract] | |
EQUITY | Note 20: - Equity a. Share capital December 31, 2022 December 31, 2021 Authorized Outstanding Authorized Outstanding Ordinary shares of NIS 1 par value 70,000,000 44,832,843 70,000,000 44,799,794 b. Movement in share capital: Issued and outstanding share capital: Number of shares Balance as of January 1, 2021 44,742,963 Issue of shares - Exercise of options into shares 4,293 Vesting of restricted shares 52,538 Balance as of December 31, 2021 44,799,794 Issue of shares - Exercise of options into shares 1,421 Vesting of restricted shares 31,628 Balance as of December 31, 2022 44,832,843 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 share During 2022 and 2021, 8,325 and 28,672 share options, respectively, were exercised, on a net exercise basis, into 1,408 For additional information regarding options and restricted shares granted to employees and management in 2022, refer to Note 21 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 On November 21, 2019, FIMI Opportunity Fund 6, L.P. and FIMI Israel Opportunity Fund 6, Limited Partnership (the “FIMI Funds”) acquired 5,240,956 ordinary shares at a price of $6.00, representing ownership of approximately 13% of the Company’s outstanding shares. 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”). Pursuant to the private placement the Company issued 4,166,667 ordinary shares at a price of $6.00 per share, for total gross proceeds of $25,000 thousands. Upon closing of the private placement, the FIMI Funds aggregate ownership represented 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. Uri Botzer, members of our board of directors, are executives of the FIMI Funds. |
Share-Based Payment
Share-Based Payment | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure of terms and conditions of share-based payment arrangement [abstract] | |
SHARE-BASED PAYMENT | Note 21: - Share-Based Payment On July 24, 2011, the Company’s Board of Directors approved an unregistered share option plan. In September 2016, the Company’s Board of Directors approved an amendment to the plan, to include 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% on the first anniversary of the grant date and 6.25% at the end of each quarter thereafter. As of 2020, granted share options and RS vest in four equal annual installments of 25% each. In August 2021, the Board of Directors approved a 10-year extension of the 2011 Plan. In February 2022, the Board of Directors adopted the U.S. Taxpayer Appendix to the 2011 Plan (the “U.S. Appendix”), which provides for the grant of options and restricted shares (RS) to persons who are subject to U.S. federal income tax. The U.S. Appendix provides for the grant to U.S. employees of options that qualify as incentive stock options (“ISOs”) under the U.S. Internal Revenue Code of 1986, as amended. The U.S. Appendix was approved by our shareholders at the annual general meeting held in December 2022. a. Expense recognized in the financial statements The share-based compensation expense that was recognized for services received from employees and members of the Board of Directors is presented in the following table: For the Year Ended December 31 2022 2021 2020 U.S. Dollar in thousands Cost of revenues $ 308 $ 69 $ 244 Research and development 204 79 184 Selling and marketing 254 34 39 General and administrative 372 347 510 Total share-based compensation $ 1,138 $ 529 $ 977 b. Share options granted: On February 28, 2022, the Company’s Board of Directors approved the grant of options to purchase up to 1,327,500, 400,000 and 270,000 ordinary shares of the Company to employees and executive officers, the CEO and Board of Directors members, respectively, under the 2011 Plan and the US Appendix. As of December 31, 2022, the Company granted, out of the above mentioned, to employees and executive officers the following: Under the Israeli Share Option Plan: - On February 28, 2022, 1,105,100 options to purchase the ordinary shares of the Company, at an exercise price of NIS 19.36 (USD 5.97) per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at $2,162 thousands. - On March 1, 2022, 10,000 options to purchase the ordinary shares of the Company, at an exercise price of NIS 19.54 (USD 6.04) per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at $20 thousands. - On March 13, 2022, 15,000 options to purchase the ordinary shares of the Company, at an exercise price of NIS 18.92 (USD 5.80) per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at $29 thousands. - On December 22, 2022, the Company’s shareholders approved the grant of options to purchase 400,000 Ordinary Shares of the Company at an exercise price of NIS 21.34 per share to the Company’s CEO. The fair value of the options was calculated based on the binomial option valuation model, was $447 thousands, respectively. - On December 22, 2022, the Company’s shareholders approved the grant of options to purchase 270,000 Ordinary Shares of the Company at an exercise price of NIS 17.35-19.36 per share to the Company’s Board of Directors members. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at $282 thousands. Under the US Appendix: - On February 28, 2022, 23,100 options to purchase the ordinary shares of the Company, at an exercise price of USD 6.10 per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at $51 thousands. - On March 1, 2022, 18,100 options to purchase the ordinary shares of the Company, at an exercise price of USD 6.06 per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at $40 thousands. - On March 15, 2022, 60,000 options to purchase the ordinary shares of the Company, at an exercise price of USD 5.88 per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at $135 thousands. - On May 1, 2022, 18,100 options to purchase the ordinary shares of the Company, at an exercise price of USD 5.64 per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at $40 thousands. - On September 1, 2022, 18,100 options to purchase the ordinary shares of the Company, at an exercise price of USD 5.16 per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at $36 thousands. On August 23, 2022, the Company’s Board of Directors approved the grant of 79,300 options to purchase ordinary shares of the Company. Under the Israeli Share Option Plan: - 51,200 options to purchase the ordinary shares of the Company, at an exercise price of NIS 17.18-17.41 (USD 5.27-5.31) per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at $89 thousands. Under the US Appendix: - 28,100 options to purchase the ordinary shares of the Company, at an exercise price of USD 5.36 per share. The fair value of the options calculated on the date of grant using the binomial option valuation model was estimated at $59 thousands. On February 27, 2023, the Company’s Board of Directors approved the grant of 147,000 options to purchase ordinary shares of the Company. Under the Israeli Share Option Plan: - 143,667 options to purchase ordinary shares of the Company, at an exercise price of NIS 16.53 (USD 4.5) per share. The fair value of the options was estimated on the date of grant at $89 thousands. Under the US Appendix: - 3,333 options to purchase the ordinary shares of the Company, at an exercise price of USD 4.57 per share. The fair value of the options was estimated on the date of grant was estimated at $59 thousands. 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: 2022 2021 2020 Number of Weighted Number of Weighted Number of Weighted In NIS In NIS In NIS Outstanding at beginning of year 1,504,678 20.38 1,660,958 20.38 2,336,554 27.87 Granted 2,076,800 19.27 - - 382,000 24.36 Exercised (8,325 ) 16.47 (28,672 ) 16.93 (449,093 ) 18.49 Forfeited (325,339 ) 19.14 (127,608 ) 20.29 (608,503 ) 51.68 Outstanding at end of year 3,247,814 19.91 1,504,678 20.65 1,660,958 20.38 Exercisable at end of year 1,049,329 20.38 1,067,363 19.78 799,640 18.97 The weighted average remaining contractual life for the share options 4.67 3.33 4.18 The range of exercise prices for share options outstanding as of December 31, 2022 and 2021 were NIS 16.47- NIS 20.33. Exercise is by net exercise method. f. The following table lists the number of RSs and changes in RSs grants during the year: Number of RSs 2022 2021 2020 Outstanding at beginning of year 49,561 104,519 145,896 Granted - - 30,000 End of restriction period (31,608 ) (52,538 ) (58,328 ) Forfeited (3,248 ) (2,420 ) (13,049 ) Outstanding at end of year 14,105 49,561 104,519 The weighted average remaining contractual life for the restricted share 0.96 3.40 4.39 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. Under the Israeli Share Option Plan: 2022 (1) 2021 2020 Dividend yield (%) - - - Expected volatility of the share prices (%) 23-40 - 30-55 Risk-free interest rate (%) 0.4-3.55 - 0.01 – 0.58 Contractual term of up to (years) 6.5 - 6.5 Exercise multiple 2 - 2 Weighted average share prices (NIS) 13.6-18.41 - 20.28-28.98 Expected average forfeiture rate (%) 0-8.5 - 1.9-5.9 (1) During the year ended December 31, 2022, no grants of options or RS were made Under the US Appendix: 2022 2021 2020 Dividend yield (%) - - - Expected volatility of the share prices (%) 27-47 - - Risk-free interest rate (%) 0.91-3.54 - - Contractual term of up to (years) 6.5 - - Exercise multiple - - - Weighted average share prices (NIS) 4.8-5.37 - - Expected average forfeiture rate (%) 1.9-8.5 - - |
Taxes on Income
Taxes on Income | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure of income tax [abstract] | |
TAXES ON INCOME | Note 22: - 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 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 Company’s benefit period 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 affected (“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. Pursuant to the Tax Ruling, the Year of Election was 2009. The Company also subsequently elected 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 Company's tax benefits under our Privileged Enterprise are scheduled to expire at the end of 2023. 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 order for industrial enterprises to comply with this condition, in each tax year during the benefit period, one of the following conditions must be met: 1. The industrial enterprise's main field of activity is biotechnology or nanotechnology as approved by the Head of the Administration of Industrial Research and Development, prior to the approval of the relevant program. 2. The industrial enterprise's sales revenues in a specific market during the tax year do not exceed 75% of its total sales for that tax year. A "market" is defined as a separate country or customs territory. 3. At least 25% of the industrial enterprise's overall revenues during the tax year were generated from the enterprise's sales in a specific market with a population of at least 14 million. 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). Amendment 68 to the Encouragement Law: 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”. Similar 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 Israeli parliament passed a 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 parliament 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. Amendment 73 to the Encouragement Law: Amendment 73 to the Encouragement Law also prescribes special tax tracks for technological enterprises, which became effective in 2017, as follows: Preferred technological enterprise, which is defined in the Encouragement Law as a company that owns the enterprise and is a member of a group whose total consolidated revenues are less than NIS 10 billion in the tax year, will be subject to tax at a rate of 12% on profits deriving from intellectual property (in development area A - a tax rate of 7.5%).Special preferred technological enterprise which is a member of a group whose total consolidated revenues exceed NIS 10 billion in the tax year will be subject to tax at a rate of 6% on preferred income from the enterprise, regardless of the enterprise’s geographical location. Any dividends distributed to “foreign companies”, as defined in the Encouragement Law, deriving from income from the technological enterprises will be subject to tax at a rate of 4%, subject to the conditions prescribed in Section 51Z to the Encouragement Law. Preferred technological enterprise, which is defined in the Encouragement Law as a company that owns the enterprise and is a member of a group whose total consolidated revenues are less than NIS 10 billion in the tax year, will be subject to tax at a rate of 12% on profits deriving from intellectual property (in development area A - a tax rate of 7.5%). Special preferred technological enterprise which is a member of a group whose total consolidated revenues exceed NIS 10 billion in the tax year will be subject to tax at a rate of 6% on preferred income from the enterprise, regardless of the enterprise's geographical location. Any dividends distributed to "foreign companies", as defined in the Encouragement Law, deriving from income from the technological enterprises will be subject to tax at a rate of 4%, subject to the conditions prescribed in Section 51Z to the Encouragement Law. b. Tax rates applicable to the Company (other than the applicable preferred tax) The Israeli corporate income tax rate was 23% since 2018. c. Tax assessments The Company has finalized tax assessments through the end of tax year 2017. d. Taxation of the subsidiaries: Kamada Inc and Kamada Plasma LLC are incorporated in the United States and are subject U.S. Federal ,State tax laws and Franchise Tax. The two subsidiaries are filling a joint tax return. On December 22, 2017, the Tax Cuts and Jobs Act (the “Act”) was signed into law. The Act reduces the corporate tax rate to 21% from 35%, among other things. On February 16, 2022 The Company incorporated KI Biopharma LLC wholly-owned subsidiary of Kamad Ltd. KI Biopharma LLC is disregard (tax transparent) entity for U.S. tax purposes. e . Carry forward losses for tax purposes and other temporary differences As of December 31, 2022, the Company has carried forward losses and other temporary differences in the amount of $26,525 thousands. Final tax assessments for the years 2018 onwards could have an impact on the balance of carry forward tax losses for which deferred tax asset was not recognized. As of December 31, 2022, The Company did not record deferred tax asset for the remaining carry forward losses due to estimation that their utilization in the foreseeable future is not probable. f . 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, 2022 and 2021, the application of IFRIC 23 did not have a material effect on the financial statements. g . 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. As of December 31, 2022 and 2021, the Company did not record deferred tax asset for the remaining carry forward losses due to estimation that their utilization in the foreseeable future is not probable. 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. h . Composition: Statements of Year ended December 31, 2022 2021 2020 U.S Dollars in thousands Deferred tax assets: Carryforward tax losses - - (1,330 ) Employee benefits Deferred tax income (expenses) - - (1,330 ) Deferred tax assets, net i . Taxes on income Year ended December 31, 2022 2021 2020 U.S. Dollars in thousands Current taxes $ 62 $ 345 $ 95 Deferred tax expenses (income) - - 1,330 Taxes in respect of prior years - - Taxes on income $ 62 345 $ 1,425 j . Theoretical tax The reconciliation between the statutory tax rate and the effective tax rate as recorded in profit or loss for the year ended in 2022 and 2021, does not provide significant information, and therefore was not presented. The table below represent the reconciliation between the statutory tax rate and the effective tax rate as recorded in profit or loss Year ended 2020 U.S. Dollars in Gain before taxes on income $ 18,565 Statutory tax rate 23 % Tax calculated using the statutory tax rate 4,270 Increase (decrease) in taxes resulting from permanent differences - the tax effect: Adjustment of deferred tax balances following a change in tax rates Taxable income with preferred income tax rates by virtue of the Encouragement Law (3,082 ) Tax exempt income, income subject to special tax rates and nondeductible expenses and other (303 ) Difference between measurement basis of income/expenses for tax purposes and measurement basis of income/expenses for financial reporting purposes 441 Increase in unrecognized tax losses in the year - Prior year taxes - Other 99 Tax on income $ 1,425 Effective tax rate 7.7 % |
Supplementary Information to th
Supplementary Information to the Statements of Profit and Loss | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure Of Supplementary Information To Statements Of Comprehensive Loss Explanatory Abstract | |
SUPPLEMENTARY INFORMATION TO THE STATEMENTS OF PROFIT AND LOSS | Note 23: - Supplementary Information to the Statements of Profit and Loss a. Additional information about revenues Year Ended December 31, 2022 2021 2020 U.S. Dollars in thousands Revenues from major customers each of whom amount to 10% or more, of total revenues Customer A (1) 16,195 11,947 18,290 Customer B (2) $ 14,205 $ 31,936 $ 65,081 Customer C (3) 12,255 12,357 13,793 $ 42,655 $ 56,240 $ 97,164 (2) Revenue is attributed to the Proprietary segment. Refer to Note 18 (a) for more information. (3) Revenue is attributed mainly to the Distribution segment. b. Revenues based on the location of the customers, are as follows: Year Ended December 31, 2022 2021 2020 U.S. Dollars in thousands U.S.A and North America $ 75,851 $ 49,763 $ 84,949 Israel 32,031 35,774 36,144 Europe 5,277 5,677 4,461 Latin America 11,293 9,127 6,867 Asia 4,581 3,167 766 Others 305 134 59 Total Revenue $ 129,338 $ 103,642 $ 133,246 c. Cost of goods sold Year Ended December 31, 2022 2021 2020 U.S. Dollars in thousands Cost of materials (1) $ 53,666 $ 63,945 $ 54,745 Salary and related expenses (2) 14,967 17,486 17,957 Subcontractors 4,673 4,892 4,876 Depreciation and amortization (3) 8,553 3,627 3,248 Energy 1,365 1,464 1,626 Other manufacturing expenses 1,785 1,298 575 85,009 92,712 83,027 Decrease (increase) in inventories (2,373 ) (19,398 ) 2,667 Total Cost of goods sold $ 82,636 $ 73,314 $ 85,694 (1) Costs of materials for the year ended December 31, 2021, includes $24,282 of inventory obtained in connection with the business combination. Refer to Note 5b for further detail on the business combination. (2) Reduction of salary and related expenses was attributable to the 2022 labor strike. (3) Including amortization of intangible assets in the amount of $5,376, $574, and $0 for the years ended December 31, 2022, 2021 and 2020, respectively d. Research and development Year Ended December 31, 2022 2021 2020 U.S. Dollars in thousands Salary and related expenses $ 5,608 $ 5,076 $ 6,045 Subcontractors 4,216 3,656 4,794 Materials and allocation of facility costs 2,538 1,896 1,682 Depreciation and amortization 574 616 725 Others 236 113 363 Total Research and development $ 13,172 $ 11,357 $ 13,609 For additional information regarding government grant refer to Note 13(b) e. Selling and marketing Year Ended December 31, 2022 2021 2020 U.S. Dollars in thousands Salary and related expenses $ 4,047 1,930 1,639 Marketing support 668 136 144 Packing, shipping and delivery 1,484 912 750 Marketing and advertising 2,812 1,193 586 Registration and marketing fees 3,463 1,262 934 Depreciation and amortization (1) 2,056 488 147 Others 754 357 318 Total Selling and marketing $ 15,284 $ 6,278 $ 4,518 (1) Including amortization of intangible assets in the amount of $1,807, $265, and $0 for the years ended December 31, 2022, 2021 and 2020, respectively f. General and administrative Year Ended December 31, 2022 2021 2020 U.S. Dollars in thousands Salary and related expenses $ 4,455 $ 3,853 3,870 Employees welfare 1,299 1,259 978 Professional fees and public company expense 4,213 5,055 3,135 Depreciation, amortization and impairment 973 875 779 Communication and software services 905 977 924 Others 958 617 453 Total General and administrative $ 12,803 $ 12,636 $ 10,139 g. Financial (expense) income Year Ended December 31, 2022 2021 2020 U.S. Dollars in thousands Financial income Interest income and gains from marketable securities $ 91 $ 295 $ 1,027 Financial expense Revaluation of long term liabilities (6,266 ) (994 ) - Fees and interest paid to financial institutions (914 ) (283 ) (266 ) Financial income and (expense) Derivatives instruments measured at fair value 548 (565 ) (1,097 ) Translation differences of financial assets and liabilities (250 ) 358 (438 ) Bond securities measured at fair value - - 102 Total Financial (expense) income $ (6,791 ) $ (1,189 ) $ (672 ) |
Income (Loss) Per Share
Income (Loss) Per Share | 12 Months Ended |
Dec. 31, 2022 | |
Income (Loss) Per Share [abstract] | |
INCOME (LOSS) PER SHARE | Note 24: - 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, 2022 2021 2020 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 U.S. Dollars U.S. Dollars U.S. Dollars For the computation of basic income (loss) 44,815,248 (2,321 ) 44,771,766 $ (2,230 ) 44,140,771 $ 17,140 Effect of potential dilutive ordinary shares 41,328 130,177 - 449,107 - For the computation of diluted income (loss) 44,856,576 (2,321 ) 44,901,943 $ (2,230 ) 44,589,878 $ 17,140 b. The computation of the diluted income per share for the years ending December 31, 2022, 2021 and 2020 considered the options and RSs due to their dilutive effect. |
Operating Segments
Operating Segments | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure of operating segments [abstract] | |
OPERATING SEGMENTS | Note 25: - 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 corporate office, 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 Company basis. b. Reporting on operating segments Proprietary Distribution Total U.S. Dollars in thousands Year Ended December 31, 2022 Revenues $ 102,598 26,741 129,339 Gross profit $ 44,369 2,334 46,703 Unallocated corporate expenses (42,171 ) Finance income, net (6,791 ) Income before taxes on income (2,259 ) Proprietary Distribution Total U.S Dollars in thousands Year Ended December 31, 2021 Revenues $ 75,521 $ 28,121 $ 103,642 Gross profit $ 27,327 $ 3,001 $ 30,328 Unallocated corporate expenses (31,024 ) Finance income, net (1,189 ) Income before taxes on income $ (1,885 ) Proprietary Distribution Total U.S. Dollars in thousand Year Ended December 31, 2020 Revenues $ 100,916 $ 32,330 $ 133,246 Gross profit $ 43,166 $ 4,386 $ 47,552 Unallocated corporate expenses (28,315 ) Finance expense, net (672 ) Loss before taxes on income $ 18,565 |
Balances and Transactions with
Balances and Transactions with Related Parties | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure of related party [Abstract] | |
BALANCES AND TRANSACTIONS WITH RELATED PARTIES | Note 26: - Balances and Transactions with Related Parties a. Balances with related parties December 31, December 31, U.S. Dollars in thousands Trade receivable $ 544 $ 1,295 Other accounts payables $ 186 $ 101 b. Transactions with employed/directors that accounts as related parties Year Ended December 31, 2022 2021 2020 U.S. Dollars in thousands Remuneration of directors not employed by the Company or on its behalf $ 331 $ 487 $ 506 Number of People to whom the Salary and remuneration Refer: Directors not employed by the Company 9 9 9 Total Directors employed and not employed by the Company 9 9 9 c. Transactions with key executive personnel (including non-related parties) Year Ended December 31, 2022 2021 2020 U.S. Dollars in thousands Salary and Related Expenses $ 3,590 $ 2,791 $ 3,237 Share-based payment 547 255 457 Total $ 4,137 $ 3,046 $ 3,694 d. Transactions with related parties Year Ended December 31, 2022 2021 2020 U.S. Dollars in thousands Revenues $ 5,298 $ 5,356 $ 3,899 Cost of Goods Sold $ 19 $ 51 $ 255 Selling and marketing expenses $ 0 $ 0 $ 0 General and administrative expenses $ 214 $ 227 $ 522 e. Terms of Transactions with Related Parties Sales to related parties are conducted at market prices. Outstanding trade receivables due from related parties the end of the year bears no interest and their settlement will be in cash. For the years ended December 31, 2022, 2021 and 2020, the Company recorded no allowance for doubtful accounts for trade receivable due 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. 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. In May 2020, the Company and Tuteur entered into new agreement pursuant to which Tuteur serves as the exclusive distributor of GLASSIA and KAMRHO(D) in Argentina, Paraguay, Bolivia and Uruguay. The agreement includes minimum annual purchase commitments by Tuteur for an initial 12 month period, with respect to sales of any products in territories where registration has been completed, commencing as of the effective date of the agreement and with respect to sale of any products in the other territories, commencing the first year following the registration of any such product in the applicable territory. On July 4, 2022, the Company and Tuteur entered into a supplemental letter agreement to the distribution agreement, pursuant to which Tuteur undertook to be responsible for an investigator-initiated targeted screening program for AATD in Uruguay in patients diagnosed with obtrusive pulmonary disease, with the purpose of identifying patients suitable for treatment with GLASSIA, to be conducted at Sociedad Uruguaya de Neumologia, Montevideo, Uruguay. The Company agreed to support the funding of the study up to $30,000, inclusive of all applicable taxes, and Tuteur agreed to provide the Company with all collected data, information, results and reports generated or derived as a result of the study, and to obtain in advance all necessary approvals for the study. According to the terms of the agreement, the Company is not responsible for and does not bear any liability arising from or in connection with the study. In September 2022, following a decrease in the market price of KAMRHO(D) in Argentina mainly due to the COVID-19 pandemic affect and recent changes to treatment protocols that reduced overall consumption of the product, the Board of Directors approved the reduction of the minimum supply price (as defined in the distribution agreement) of the product in Argentina and Paraguay for the 2022 supplies. In February 2023, we and Tuteur entered into an amendment to the distribution agreement, pursuant to which KAMRHO(D)’s price for the territories of Argentina and Paraguay payable by Tuteur pursuant to the agreement, will be the higher of 60% of KAMRHO(D)’s net price sold by Tuteur in these territories or a minimum supply price as defined in the amendment to the distribution agreement. In March 2023, the Board of Directors approved a one-time amendment to the payment terms under the distribution agreement with respect to two shipments of GLASSIA and KAMRHO(D) to be supplied to Tuteur by the end of the first quarter of 2023. 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, which was at the time 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. The distribution agreement with Khairi was an arm’s length transaction. For the years ended on December 31, 2019, 2020 and 2021 there were no sales of product by the Company to Khairi. The agreement expired on December 31, 2020. 3. On November 21, 2019, FIMI Opportunity Fund 6, L.P. and FIMI Israel Opportunity Fund 6, Limited Partnership (the “FIMI Funds”) acquired 5,240,956 ordinary shares at a price of $6.00, representing ownership of approximately 13% of the Company’s outstanding shares. 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”). Pursuant to the private placement the Company issued 4,166,667 ordinary shares at a price of $6.00 per share, for total gross proceeds of $25,000 thousands. Upon closing of the private placement, the FIMI Funds aggregate ownership represented 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. Uri Botzer, members of our board of directors, are executives of the FIMI Funds. The following Israeli entities: Baran Advanced Technologies (1986) Ltd., Tri-Wall Containers (Israel) Ltd., Frenkel - C.D. Ltd., Ophir & Shalpharm Medicines & Cosmetics Ltd., Grafity Office Equipment Marketing, G-One Security Solutions, Infinya Packaging Ltd., Infinya Recycling Ltd., Spider Solutions Ltd., Emet E&M Computing, which are controlled by or affiliated with 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 at market prices. f. CEO employment terms On March 2020, the Company’s shareholders approved an amendment to the employment terms of the Company’s CEO, pursuant to which the monthly gross salary was increased to NIS 88,000 (or $25,462), effective as July 1, 2019. On October 12, 2021, the Company’s Board of Directors approved an amendment to the employment terms of the Company’s CEO, pursuant to which the CEO’s monthly gross salary increased to NIS 92,400 (or $28,607), effective as of July 1, 2021. On November 21, 2022, the Company’s Board of Directors approved an amendment to the employment terms of the Company’s CEO, pursuant to which the CEO’s monthly gross salary increased to NIS 96,000 (or $28,575), effective as of July 1, 2022. During 2022, the Company accounted for a bonus accrual to the CEO in the amount of $175 thousand. |
Events Subsequent to the Report
Events Subsequent to the Reporting Period | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure of events after reporting period [abstract] | |
EVENTS SUBSEQUENT TO THE REPORTING PERIOD | Note 27: - Events Subsequent to the Reporting Period a. With respect to grant of options to employees see Note 21b b. With respect to an amendment to the distribution agreement with Tuteur see Note 26e1 |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
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 assets measured at fair value through other comprehensive income (“OCI”); and financial assets and liabilities (including derivatives and contingent consideration) which are presented at fair value through profit or loss. (See Note 14). 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. |
Business combinations and goodwill | d. Business combinations and goodwill: Upon consummation of an acquisition, and for the purpose of determining the appropriate accounting treatment, the Company examines whether the transaction constitutes an acquisition of a business or assets. In determining whether a particular set of activities and assets is a business, the Company assesses whether the set of assets and activities acquired includes, at a minimum, an input and substantive process and whether the acquired set has the ability to produce outputs. The Company has an option to apply a ‘concentration test’ that permits a simplified assessment of whether an acquired set of activities and assets is not a business. The optional concentration test is met if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. Transactions in which the acquired is considered a business are accounted for as a business combination as described below. Conversely, transactions not considered as business acquisition are accounted for as acquisition of assets and liabilities. In such transactions, the cost of acquisition, which includes transaction costs, is allocated proportionately to the acquired identifiable assets and liabilities, based on their proportionate fair value on the acquisition date. In an assets acquisition, no goodwill is recognized, and no deferred taxes are recognized in respect of the temporary differences existing on the acquisition date. Business combinations are accounted for by applying the acquisition method. The cost of the acquisition is measured at the fair value of the consideration transferred on the acquisition date. Costs associated with the acquisition that were incurred by the Company in the business combination such as: finder’s fees, advisory, legal, valuation and other professional or consulting fees, other than those associated with an issue of debt or equity instruments connected to the business combination, are expensed in the period the services are received. Contingent consideration is recognized at fair value on the acquisition date and classified as a financial asset or liability in accordance with IFRS 9. Subsequent changes in the fair value of the contingent consideration are recognized in profit or loss as finance income or finance expense. If the contingent consideration is classified as an equity instrument, it is measured at fair value on the acquisition date without subsequent remeasurement. The fair value of an acquiree’s previously recognized contingent consideration assumed in connection with a business combination is recognized as financial liability on the acquisition date. Subsequently, the financial liability is measured at amortized cost, per IFRS 9. Remeasurement of the financial liability is recognized as finance income or expense in the statement of operations. Goodwill is initially measured at cost which represents the excess of the acquisition consideration over the net identifiable assets acquired and liabilities assumed. |
Financial instruments | Contingent consideration is recognized at fair value on the acquisition date and classified as a financial asset or liability in accordance with IFRS 9. Subsequent changes in the fair value of the contingent consideration are recognized in profit or loss as finance income or finance expense. If the contingent consideration is classified as an equity instrument, it is measured at fair value on the acquisition date without subsequent remeasurement. The fair value of an acquiree’s previously recognized contingent consideration assumed in connection with a business combination is recognized as financial liability on the acquisition date. Subsequently, the financial liability is measured at amortized cost, per IFRS 9. Remeasurement of the financial liability is recognized as finance income or expense in the statement of operations. Goodwill is initially measured at cost which represents the excess of the acquisition consideration over the net identifiable assets acquired and liabilities assumed. e. 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. f. 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. g. Short-term investments Short-term investments comprised of 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. h. Inventories Inventories are measured at the lower of cost and net realizable value. The cost of inventories comprises of the 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. The Company determines a standard manufacturing capacity for each quarter. To the extent the actual manufacturing capacity in a given quarter is lower than the predetermined standard, than a portion of the indirect costs which is equal to the product of the overall quarterly indirect costs multiplied by the quarterly manufacturing shortfall rate is recognized as costs of revenues 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 and development 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 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. If a contract with a customer does not meet all of the above criteria, consideration received from the customer is recognized as a liability until the criteria are met or when one of the following events occurs: the Company has no remaining obligations to transfer goods or services to the customer and any consideration promised by the customer has been received and cannot be returned; or the contract has been terminated and the consideration received from the customer cannot be refunded. 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. In order to examine whether a promise to transfer goods or services is separately identifiable, the Company examines whether it is providing a significant service of integrating the goods or services with other goods or services promised in the contract into one integrated outcome that is the purpose of the contract. Option to purchase additional goods or services An option that grants the customer the right to purchase additional goods or services constitutes a separate performance obligation in the contract only if the option grants to the customer a material right it would not have received without the original 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. In cases where the difference between the time of receiving payment and the time of transferring the goods or services to the customer is one year or less, the Company applies the practical expedient included in the standard and does not separate a significant financing component. 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. Costs to fulfill a contract: Costs incurred in fulfilling contracts or anticipated contracts with customers are recognized as an asset when the costs generate or enhance the Company’s resources that will be used in satisfying or continuing to satisfy the performance obligations in the future and are expected to be recovered. Costs to fulfill a contract comprise direct identifiable costs and indirect costs that can be directly attributed to a contract based on a reasonable allocation method. Costs to fulfill a contract are amortized on a systematic basis that is consistent with the provision of the services under the specific contract. An impairment loss in respect of capitalized costs to fulfill a contract is recognized in profit or loss when the carrying amount of the asset exceeds the remaining amount of consideration that the Company expects to receive for the goods or services to which the asset relates less the costs that relate directly to providing those goods or services and that have not been recognized as expenses. Principal or agent When another party is involved in providing goods or services to the customer, the Company examines whether the nature of its promise is a performance obligation to provide the defined goods or services itself, which means the Company is a principal and therefore recognizes revenue in the gross amount of the consideration, or to arrange that another party provide the goods or services which means the Company is an agent and therefore recognizes revenue in the amount of the net commission. The Company is a principal when it controls the promised goods or services before their transfer to the customer. Indicators that the Company controls the goods or services before their transfer to the customer include, inter alia, as follows: the Company is responsible for fulfilling the promises in the contract; the Company has inventory risk before the goods or services are transferred to the customer; and the Company has discretion in setting the prices of the goods or services. Analysis of major contracts: As of December 31, 2022, 2021 and 2020, the Company generated revenue mainly from the sale of products to strategic partners and distributors as well as from the licensing of its technology and distribution rights. In the majority of contracts, revenue recognition occurs at a point in time when control of the Company’s product is transferred to the customer, generally on delivery of the goods. The Company determines the transaction price separately for each contract with a customer taking into consideration variable prices, discounts, chargeback, rebates, etc. 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. With regards to a certain contract with its strategic partner the Company analyzed the following: The Company identified few performance obligations which include: a. Grant of a license for distribution of 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 a 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. The Company determines the transaction price and allocates the transaction price to the different performance obligation identified. 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. As of 2022, the Company also generates revenue in the form of royalty payments, due from the grant of a license for the use of the Company’s knowledge and patents. Royalty revenue is recognized when the underlying sales have occurred. Following the acquisition of CYTOGAM, WINRHO SDF, VARIZIG and HEPGAM B during November 2021, the Company, through its wholly-owned subsidiary Kamada Inc., sells these products in the U.S. market to wholesalers/distributors that redistribute/sell these products to other parties such as hospitals and pharmacies. Revenue recognition occurs at a point in time when control of the product is transferred to the wholesalers/distributors, generally on delivery of the goods. The Company’s gross sales are subject to various deductions, which are primarily composed of rebates and discounts to group purchasing organizations, government agencies, wholesalers, health insurance companies and managed healthcare organizations. These deductions represent estimates of the related obligations, requiring the use of judgment when estimating the effect of these sales deductions on gross sales for a reporting period. These adjustments are deducted from gross sales to arrive at net sales. The Company monitors the obligation for these deductions on at least a quarterly basis and records adjustments when rebate trends, rebate programs and contract terms, legislative changes, or other significant events indicate that a change in the obligation is appropriate. The following summarizes the nature of the most significant adjustments to revenues generated from the sales of these products in the U.S. market: Wholesaler chargebacks: The Company has arrangements with certain indirect customers whereby the customer is able to buy products from wholesalers at reduced prices. Fees for service: Consists of wholesaler/distributor fees. The wholesalers/distributors charge the Company fees for the redistribution of the products to hospitals and pharmacies. These fees are outlined in each wholesaler/distributor contract. The fees are invoiced to the Company monthly or quarterly by the wholesaler/distributor. The provisions for fees for service are recorded in the same period that the corresponding revenues are recognized. Deferred revenues Deferred revenues include unearned amounts received from customers not yet recognized as revenues. k. Government grants: Government grants are recognized when there is reasonable assurance that the grants will be received, and the Company will comply with the grant attached conditions. Government grants received from the Israel Innovation Authority (formerly: the Office of the Chief Scientist in Israel, “the IIA”) are recognized upon receipt as a liability if future economic benefits are expected from the research project that will result in royalty-bearing sales. A liability for the loan is first measured at fair value using a discount rate that reflects a market rate of interest. The difference between the amount of the grant received and the fair value of the liability is accounted for as a government grant and recognized as a reduction of research and development expenses. After initial recognition, the liability is measured at amortized cost using the effective interest method. Royalty payments are treated as a reduction of the liability. If no economic benefits are expected from the research activity, the grant receipts are recognized as a reduction of the related research and development expenses. In that event, the royalty obligation is treated as a contingent liability in accordance with IAS 37. l. Taxes on income Taxes on income in profit or loss comprise of current taxes, deferred taxes and taxes in respect of prior years, which 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. Uncertain tax positions A provision for uncertain tax positions, including additional tax and interest expenses, is recognized when it is more probable than not that the Company will have to use its economic resources to pay the obligation. As of December 31, 2022 and 2021, the application of IFRIC 23 did not have a material effect on the financial statements. m. Leases The Company accounts for a contract as a lease according to IFRS 16, “Leases” (“Lease Standard”), 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 the Lease 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 33 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 16. n. 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 |
Functional currency, presentation currency and foreign currency | e. Functional currency, presentation currency and foreign currency 1. Functional currency and presentation currency The consolidated financial statements are presented in U.S. dollars, which is the Company’s functional and presentation currency. 2. Transactions, assets and liabilities in foreign currency Transactions denominated in foreign currency are recorded on initial recognition at the exchange rate at the date of the transaction. After initial recognition, monetary assets and liabilities denominated in foreign currency are translated at the end of each reporting period into the functional currency at the exchange rate at that date. Exchange differences are recognized in profit or loss. Non-monetary assets and liabilities measured at cost in a foreign currency are translated at the exchange rate at the date of the transaction. |
Cash and cash equivalents | f. 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 | g. Short-term investments Short-term investments comprised of 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. |
Inventories | h. Inventories Inventories are measured at the lower of cost and net realizable value. The cost of inventories comprises of the 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. The Company determines a standard manufacturing capacity for each quarter. To the extent the actual manufacturing capacity in a given quarter is lower than the predetermined standard, than a portion of the indirect costs which is equal to the product of the overall quarterly indirect costs multiplied by the quarterly manufacturing shortfall rate is recognized as costs of revenues 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 and development 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 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. If a contract with a customer does not meet all of the above criteria, consideration received from the customer is recognized as a liability until the criteria are met or when one of the following events occurs: the Company has no remaining obligations to transfer goods or services to the customer and any consideration promised by the customer has been received and cannot be returned; or the contract has been terminated and the consideration received from the customer cannot be refunded. 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. In order to examine whether a promise to transfer goods or services is separately identifiable, the Company examines whether it is providing a significant service of integrating the goods or services with other goods or services promised in the contract into one integrated outcome that is the purpose of the contract. Option to purchase additional goods or services An option that grants the customer the right to purchase additional goods or services constitutes a separate performance obligation in the contract only if the option grants to the customer a material right it would not have received without the original 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. In cases where the difference between the time of receiving payment and the time of transferring the goods or services to the customer is one year or less, the Company applies the practical expedient included in the standard and does not separate a significant financing component. 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. Costs to fulfill a contract: Costs incurred in fulfilling contracts or anticipated contracts with customers are recognized as an asset when the costs generate or enhance the Company’s resources that will be used in satisfying or continuing to satisfy the performance obligations in the future and are expected to be recovered. Costs to fulfill a contract comprise direct identifiable costs and indirect costs that can be directly attributed to a contract based on a reasonable allocation method. Costs to fulfill a contract are amortized on a systematic basis that is consistent with the provision of the services under the specific contract. An impairment loss in respect of capitalized costs to fulfill a contract is recognized in profit or loss when the carrying amount of the asset exceeds the remaining amount of consideration that the Company expects to receive for the goods or services to which the asset relates less the costs that relate directly to providing those goods or services and that have not been recognized as expenses. Principal or agent When another party is involved in providing goods or services to the customer, the Company examines whether the nature of its promise is a performance obligation to provide the defined goods or services itself, which means the Company is a principal and therefore recognizes revenue in the gross amount of the consideration, or to arrange that another party provide the goods or services which means the Company is an agent and therefore recognizes revenue in the amount of the net commission. The Company is a principal when it controls the promised goods or services before their transfer to the customer. Indicators that the Company controls the goods or services before their transfer to the customer include, inter alia, as follows: the Company is responsible for fulfilling the promises in the contract; the Company has inventory risk before the goods or services are transferred to the customer; and the Company has discretion in setting the prices of the goods or services. Analysis of major contracts: As of December 31, 2022, 2021 and 2020, the Company generated revenue mainly from the sale of products to strategic partners and distributors as well as from the licensing of its technology and distribution rights. In the majority of contracts, revenue recognition occurs at a point in time when control of the Company’s product is transferred to the customer, generally on delivery of the goods. The Company determines the transaction price separately for each contract with a customer taking into consideration variable prices, discounts, chargeback, rebates, etc. 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. With regards to a certain contract with its strategic partner the Company analyzed the following: The Company identified few performance obligations which include: a. Grant of a license for distribution of 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 a 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. The Company determines the transaction price and allocates the transaction price to the different performance obligation identified. 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. As of 2022, the Company also generates revenue in the form of royalty payments, due from the grant of a license for the use of the Company’s knowledge and patents. Royalty revenue is recognized when the underlying sales have occurred. Following the acquisition of CYTOGAM, WINRHO SDF, VARIZIG and HEPGAM B during November 2021, the Company, through its wholly-owned subsidiary Kamada Inc., sells these products in the U.S. market to wholesalers/distributors that redistribute/sell these products to other parties such as hospitals and pharmacies. Revenue recognition occurs at a point in time when control of the product is transferred to the wholesalers/distributors, generally on delivery of the goods. The Company’s gross sales are subject to various deductions, which are primarily composed of rebates and discounts to group purchasing organizations, government agencies, wholesalers, health insurance companies and managed healthcare organizations. These deductions represent estimates of the related obligations, requiring the use of judgment when estimating the effect of these sales deductions on gross sales for a reporting period. These adjustments are deducted from gross sales to arrive at net sales. The Company monitors the obligation for these deductions on at least a quarterly basis and records adjustments when rebate trends, rebate programs and contract terms, legislative changes, or other significant events indicate that a change in the obligation is appropriate. The following summarizes the nature of the most significant adjustments to revenues generated from the sales of these products in the U.S. market: Wholesaler chargebacks: The Company has arrangements with certain indirect customers whereby the customer is able to buy products from wholesalers at reduced prices. Fees for service: Consists of wholesaler/distributor fees. The wholesalers/distributors charge the Company fees for the redistribution of the products to hospitals and pharmacies. These fees are outlined in each wholesaler/distributor contract. The fees are invoiced to the Company monthly or quarterly by the wholesaler/distributor. The provisions for fees for service are recorded in the same period that the corresponding revenues are recognized. Deferred revenues Deferred revenues include unearned amounts received from customers not yet recognized as revenues. |
Government grants | k. Government grants: Government grants are recognized when there is reasonable assurance that the grants will be received, and the Company will comply with the grant attached conditions. Government grants received from the Israel Innovation Authority (formerly: the Office of the Chief Scientist in Israel, “the IIA”) are recognized upon receipt as a liability if future economic benefits are expected from the research project that will result in royalty-bearing sales. A liability for the loan is first measured at fair value using a discount rate that reflects a market rate of interest. The difference between the amount of the grant received and the fair value of the liability is accounted for as a government grant and recognized as a reduction of research and development expenses. After initial recognition, the liability is measured at amortized cost using the effective interest method. Royalty payments are treated as a reduction of the liability. If no economic benefits are expected from the research activity, the grant receipts are recognized as a reduction of the related research and development expenses. In that event, the royalty obligation is treated as a contingent liability in accordance with IAS 37. |
Taxes on income | l. Taxes on income Taxes on income in profit or loss comprise of current taxes, deferred taxes and taxes in respect of prior years, which 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. Uncertain tax positions A provision for uncertain tax positions, including additional tax and interest expenses, is recognized when it is more probable than not that the Company will have to use its economic resources to pay the obligation. As of December 31, 2022 and 2021, the application of IFRIC 23 did not have a material effect on the financial statements. |
Leases | m. Leases The Company accounts for a contract as a lease according to IFRS 16, “Leases” (“Lease Standard”), 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 the Lease 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 33 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 16. |
Property, plant and equipment | n. 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. |
Intangible assets | o. Intangible assets Separately acquired intangible assets are measured on initial recognition at cost including directly attributable costs. Intangible assets acquired in a business combination are measured at fair value at the acquisition date. Expenditures relating to internally generated intangible assets, excluding capitalized development costs, are recognized in profit or loss when incurred. Intangible assets with a finite useful life are amortized on a straight-line basis over its useful life and reviewed for impairment whenever there is an indication that the asset may be impaired. The amortization period and the amortization method for an intangible asset are reviewed at least at each year end. Intangible assets with indefinite useful lives are not systematically amortized and are tested for impairment annually or whenever there is an indication that the intangible asset may be impaired. The useful life of these assets is reviewed annually to determine whether their indefinite life assessment continues to be supportable. If the events and circumstances do not continue to support the assessment, the change in the useful life assessment from indefinite to finite is accounted for prospectively as a change in accounting estimate and on that date the asset is tested for impairment. Commencing from that date, the asset is amortized systematically over its useful life. Estimated life Amortization method Intellectual property 15-20 Straight-line Customer Relations 20 Straight-line Production agreement 6 Straight-line Distribution right 10-15 Straight-line over the contract period Goodwill Indefinite Not amortized |
Impairment of non-financial assets | p. 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, other than goodwill, 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. Goodwill: The Company reviews goodwill for impairment once a year, on December 31, or more frequently if events or changes in circumstances indicate that there is an impairment. Goodwill is tested for impairment by assessing the recoverable amount of the cash-generating unit (or group of cash-generating units) to which the goodwill has been allocated. An impairment loss is recognized if the recoverable amount of the cash-generating unit (or group of cash-generating units) to which goodwill has been allocated is less than the carrying amount of the cash-generating unit (or group of cash-generating units). Any impairment loss is allocated first to goodwill. Impairment losses recognized for goodwill cannot be reversed in subsequent periods. |
Fair value measurement | r. 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, by other financial assets, by goods or services or is legally released from the liability. |
Derivative financial instruments designated as hedges | s. 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 | t. 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 | u. 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 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, 1963 (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, with respect to certain other employees who were hired by the company prior to the establishment of the defined contribution plans pursuant to Section 14 to the Israeli Severance Pay Law, 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 defined benefit plan obligation, the Company makes current deposits in pension funds and insurance companies (“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. U.S. employees defined contribution plan: As of August 2022, the U.S. Subsidiary has a 401(k) defined contribution plan covering certain employees in the U.S. All eligible employees may elect to contribute up to 100%, but generally not greater than $20.5 thousands per year (for certain employees over 50 years of age the maximum contribution is $27 thousands per year), of their annual compensation to the plan through salary deferrals, subject to Internal Revenue Service limits. The U.S. Subsidiary matches 3% of employee contributions up to the plan with no limitation. |
Share-based payment transactions | v. Share-based payment transactions The Company’s employees and members of its Board of Directors 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 share) with employees and members of the Board of Directors 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 share 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 or directors 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 | w. 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 | x. 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. |
Significant Accounting Polici_2
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Significant Accounting Policies [Abstract] | |
Schedule of depreciation of right-of-use asset useful life | % Mainly % Land and Buildings 10 10 Vehicles 20-33 33 office equipment (i.e. printing and photocopying machines) 20 20 |
Schedule of depreciation of property, plant and equipment useful life | % 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 intangible assets with indefinite useful lives | Estimated life Amortization method Intellectual property 15-20 Straight-line Customer Relations 20 Straight-line Production agreement 6 Straight-line Distribution right 10-15 Straight-line over the contract period Goodwill Indefinite Not amortized |
Business Combinations (Tables)
Business Combinations (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Business Combinations [Abstract] | |
Schedule of acquisition consideration | USD in Cash paid $ 1,404 Payables for acquisition(a) 210 Total acquisition cost 1,614 (a) The acquisition consideration totaled $1,654 thousands, of which an amount of $1,404 thousands was paid at closing, and the balance of $250 thousands was paid in March 2022. The fair value of such deferred consideration was estimated at $210 as of the date of acquisition. USD in Cash paid at closing $ 95,000 Contingent consideration liability (a) 21,705 Deferred consideration (b) 13,788 Settlement of preexisting relationship (c) (3,786 ) Total acquisition cost 126,707 (a) Pursuant to the Saol APA, and in addition to the cash paid at closing, the Company agreed to pay up to $50,000 thousand of contingent consideration subject the achievement of sales thresholds for the period commencing on the Acquisition Date and ending on December 31, 2034. The Company may be entitled for up to $3,000 thousands credit deductible from the contingent consideration payments due for the years 2023 through 2027, subject to certain conditions as defined in the agreement between the parties. The contingent consideration totaled $21,705 thousands, which represents its fair value (Level 3) at the Acquisition Date, based on an Option Pricing Method (OPM), “Monte Carlo Simulation” model. In measuring the contingent consideration liability as of the Acquisition Date, the Company used an appropriate risk-adjusted discount rate of 10.6 % and volatility of 13.6%. (b) Pursuant to the Saol APA, the Company acquired inventory valued at $14,199 thousand which will be paid in ten quarterly installments of $1,500 thousand each or the remaining balance at the final installment. Such deferred inventory consideration totaled $13,788 thousand which represents the Fair value (Level 2) at the Acquisition Date. The interest rate used to calculate such fair value was based on the Company’s cost of debt which was estimated based on the long-term bank loan obtained to partially fund the acquisition. Through December 31, 2022, the Company made four quarterly installments on account of such inventory related debt. For further information about the deferred consideration, refer to Note 14b and Note 16. (c) In December 2019, the Company entered into a binding term-sheet for a 12-year contract manufacturing agreement with Saol to manufacture CYTOGAM. Through the Acquisition Date, the Company received a total of $3,786 thousand from Saol to partially fund the technology transfer activities required under such engagement. Such engagement was automatically terminated on the Acquisition Date, and such funds, previously accounted for as deferred revenues, were offset from the acquisition consideration as settlement of preexisting relationship. |
Schedule of fair value of the identifiable assets and liabilities on the acquisition date | USD in Inventories 184 Property, plant and equipment 82 Intangible assets (a) 962 1,228 Other current liability (30 ) Net identifiable assets 1,198 Goodwill arising on acquisition (b) 416 Total acquisition cost 1,614 (a) The intangible assets represent the value of the FDA license for the plasma collection facility at fair value (Level 3) at the acquisition date, based on the Greenfield Method. Under such method, the subject intangible asset is valued using a hypothetical cashflow scenario of developing an operating business in an entity that at inception only holds the subject intangible asset. In measuring the FDA license for the plasma collection facility, the Company used an appropriate discount rate of 19%. (b) The goodwill arising as part of the acquisition is attributed to the expected benefits from the synergies of the combination of the Company’s activities and those of the acquired plasma collection facility. Fair value USD Inventory(a) 22,849 Intangible assets(b) 121,174 Assumed liability(c) (47,213 ) Net identifiable assets 98,810 Goodwill arising on acquisition(d) 29,897 Total acquisition cost 126,707 (a) Inventory was valued at cost which represent its fair value. (b) The following table details the intangible assets identified (c) Pursuant to the Saol APA, the Company assumed certain of Saol’s liabilities for the future payment of royalties (some of which are perpetual) and milestone payments to third party subject to the achievement of corresponding CYTOGAM related net sales thresholds and milestones. The fair value of such assumed liabilities at the Acquisition Date was estimated at $47,213 thousand, which was calculated based on the Option Pricing Method (OPM), Monte Carlo Simulation, and discounted cash flow using a discount rate in the range of 2.25 % and 11 % and the volatility of 10.8-14.2 %. Refer to Note 14 and Note 16 for more information. (d) The goodwill arising on acquisition is attributed to the expected benefits from the synergies of the combination of the activities of the Company and the acquired business. |
Schedule of intangible assets | Fair value USD Customer Relations (1) 33,514 Intellectual property (2) 79,141 Assumed contract manufacturing agreement (3) 8,519 Total Intangible assets 121,174 (1) Customer Relations represents its fair value (Level 3) at the Acquisition Date, based on a Multi Period Excess Earnings Method (“MPEEM”). In measuring the Customer Relations, the Company used an appropriate risk-adjusted discount rate of 11% and churn rate of 5%. (2) Intellectual property represents its fair value (Level 3) at the Acquisition Date, based on a Relief from Royalties (“RFRM”) Method. In measuring the Intellectual property, the Company used an appropriate risk-adjusted discount rate of 11% and Royalties rate of 15.2%. (3) Assumed contact manufacturing agreement represents its fair value (Level 3) at the Acquisition Date, based on With and Without method. Under the With and Without method the value of an intangible asset is calculated by comparing the cash-flow in situation where the valued asset is part of the business versus the cash-flow in situation where the asset is not part of the business. The Company used an appropriate risk-adjusted discount rate of 11%. |
Cash and Cash Equivalents (Tabl
Cash and Cash Equivalents (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Cash and cash equivalents [abstract] | |
Schedule of cash and cash equivalents | December 31, 2022 2021 U.S. Dollars in Cash and deposits for immediate withdrawal $ 31,411 $ 15,371 Cash equivalents in NIS deposits (1) 2,847 3,216 Total Cash and Cash Equivalents $ 34,258 $ 18,587 (1) The deposits bear interest of 2.85%-3.8% per year, as of December 31, 2022 and 0.28% per year, as of December 31, 2021. |
Trade Receivables, Net (Tables)
Trade Receivables, Net (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Trade Receivables, Net [Abstract] | |
Schedule of trade receivables, net | December 31, 2022 2021 U.S. Dollars in Open accounts: In NIS $ 9,469 $ 16,093 In USD 17,659 18,736 $ 27,128 $ 34,829 Checks receivable 124 333 $ 27,252 $ 35,162 Less allowance for doubtful accounts(1) - - Total Trade receivables, net $ 27,252 $ 35,162 (1) As of December 31, 2022 and 2021 no allowance for doubtful accounts was recognized. |
Schedule of analysis of past due but not impaired trade receivables | Past due trade receivables with aging of Neither Up to 30 31-60 61-90 91-120 Over 121 Total December 31, 2022 $ 22,710 $ 3,260 $ 788 $ 84 $ 7 $ 402 $ 27,252 December 31, 2021 $ 33,454 $ 593 $ 572 $ 122 $ 381 $ 40 $ 35,162 |
Other Accounts Receivables (Tab
Other Accounts Receivables (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure Of Other Accounts Receivables Explanatory Abstract | |
Schedule of other accounts receivables | December 31, 2022 2021 U.S. Dollars in Prepaid expenses $ 3,875 $ 3,992 Inventory designated for R&D activities 3,732 4,407 Government authorities 645 220 Derivatives financial instruments mainly measured at fair value through other comprehensive income - 73 Accrued income 451 173 Other 7 7 Total Other Accounts Receivables $ 8,710 $ 8,872 |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Inventories [Abstract] | |
Schedule of Inventories | December 31, 2022 2021 U.S. Dollars in Finished products $ 30,429 $ 36,270 Purchased products 4,754 6,251 Work in progress 12,276 8,082 Raw materials 21,326 16,820 Total Inventories $ 68,785 $ 67,423 |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure Of Property Plant And Equipment Text Block Abstract | |
Schedule of composition and movement of property, plant and equipment | Land and Machinery Vehicles Computers, Leasehold Total U.S. Dollars in thousands Cost Balance at January 1, 2022 $ 34,543 33,439 31 9,371 1,184 78,568 Additions 547 1,906 - 966 382 3,801 Sale and write-off - (2 ) - - - (2 ) Balance as of December 31, 2022 35,090 35,343 31 10,337 1,566 82,367 Accumulated Depreciation Balance as of January 1, 2022 21,091 23,804 23 6,808 535 52,261 Depreciation 1,063 1,691 3 1,074 120 3,951 Sale and write-off - (2 ) - - - (2 ) Balance as of December 31, 2022 22,154 25,493 26 7,882 655 56,210 Depreciated cost as of December 31, 2022 $ 12,936 9,850 5 2,455 911 26,157 (1) Including labor costs charged in 2022 to the cost of facilities, machinery, and equipment in the amount of $1,043 thousands. Land and Machinery Vehicles Computers, Leasehold Total U.S. Dollars in thousands Cost Balance at January 1, 2021 $ 33,658 31,299 31 8,112 1,139 74,239 Additions 885 2,140 - 1,260 45 4,329 Balance as of December 31, 2021 34,543 33,439 31 9,371 1,184 78,568 Accumulated Depreciation Balance as of January 1, 2021 20,049 22,110 20 5,961 420 48,560 Depreciation 1,042 1,694 3 847 115 3,701 Balance as of December 31, 2021 21,091 23,804 23 6,808 535 52,261 Depreciated cost as of December 31, 2021 $ 13,451 $ 9,635 $ 8 $ 2,563 $ 649 $ 26,307 (1) Including labor costs charged in 2021 to the cost of facilities, machinery, and equipment in the amount of $775 thousands. |
Schedule of leasing rights of land from israel land administration | December 31, 2022 2021 U.S. Dollars in Under finance lease $ 1,119 $ 1,150 |
Intangible Assets, Goodwill a_2
Intangible Assets, Goodwill and Other Long Term Assets (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure Of Other Non Current Assets Text Block Abstract | |
Schedule of other long term assets | December 31, 2022 2021 U.S. Dollars in thousands Intangible Assets and Goodwill 147,009 153,592 Long term pre-paid expenses 63 71 Total Other Long-Term Assets $ 147,072 $ 153,663 (1) Includes assumed contract manufacturing agreement and distribution right of certain therapeutic products to be distributed in Israel, subject to IL MOH marketing authorization. The Company was required to make certain upfront and milestone payments on account of such distribution rights. These payments are accounted for as long-term assets through obtaining IL MOH marketing authorization and will subsequently be amortized during the expected distribution right’s useful life. 2021 |
Schedule of composition and movement | Intellectual Customer Goodwill Other Total U.S. Dollars in thousands Cost: Balance as of January 1, 2022 80,103 33,514 30,313 10,501 154,431 Purchases 600 600 Balance as of December 31, 2022 $ 80,103 $ 33,514 $ 30,313 $ 11,101 $ 155,031 Accumulated amortization and impairment: Balance as of January 1, 2022 477 179 - 183 839 Amortization recognized in the year 5,376 1,676 - 131 7,183 Balance as of December 31, 2022 5,853 1,855 - 314 8,022 Amortized cost at December 31, 2022 $ 74,250 $ 31,659 $ 30,313 $ 10,787 $ 147,009 (1) Includes assumed contract manufacturing agreement and distribution right of certain therapeutic products to be distributed in Israel, subject to IL MOH marketing authorization. The Company was required to make certain upfront and milestone payments on account of such distribution rights. These payments are accounted for as long-term assets through obtaining IL MOH marketing authorization and will subsequently be amortized during the expected distribution right’s useful life. 2021 Intellectual Customer Goodwill Other Total U.S. Dollars in thousands Cost: Balance as of January 1, 2020 - - - 1,492 1,492 Purchases 490 490 Business combination (b) 80,103 33,514 30,313 8,519 152,449 Balance as of December 31, 2021 $ 80,103 $ 33,514 $ 30,313 $ 10,501 $ 154,431 Accumulated amortization and impairment: Balance as of January 1, 2020 - - - - - Amortization recognized in the year 477 179 - 183 839 Balance as of December 31, 2020 477 179 - 183 839 Amortized cost at December 31, 2021 $ 79,626 $ 33,335 $ 30,313 $ 10,318 $ 153,592 |
Schedule of amortization expenses of intangible assets | Year ended December 31, 2022 2021 2020 USD in thousands Cost of goods sold 5,376 574 - Selling and marketing expenses 1,807 265 - 7,183 839 - |
Schedule of goodwill to cash-generating units | December 31, 2022 2021 U.S. Dollars in thousands Proprietary $ 30,313 30,313 |
Trade Payables (Tables)
Trade Payables (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure Of Trade And Other Payables Text Block Abstract | |
Schedule of trade payables | December 31, 2022 2021 U.S. Dollars in thousands Open debts mainly in USD $ 12,731 $ 7,354 Open debts in EUR 10,629 9,174 Open debts in NIS 9,557 8,576 Total Trade Payables $ 32,917 $ 25,104 |
Other Accounts Payables (Tables
Other Accounts Payables (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure Of Other Accounts Payables Explanatory Abstract | |
Schedule of other accounts payables | December 31, 2022 2021 U.S. Dollars in thousands Employees and payroll accruals $ 6,683 $ 6,348 Government grants (b) 201 207 Derivatives financial instruments 92 - Accrued Expenses and Others 609 587 Total Other Accounts Payables 7,585 $ 7,142 |
Schedule of financial statements | December 31, 2022 2021 U.S. Dollars in thousands Current Assets 3 3 Current liability 201 207 Royalties paid during the year - - Expense (income) carried to profit or loss $ 29 (29 ) |
Loans and Financial Liabiliti_2
Loans and Financial Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure Of Borrowings Text Block Abstract | |
Schedule of loans and financial liabilities | December 31, 2022 2021 U.S. Dollars in thousands Bank loans (1) 17,407 20,038 Less current maturities of bank loans 4,444 2,631 Total Long term bank loans $ 12,963 $ 17,407 1. Bank loan |
Schedule of financial liabilities | December 31, 2022 2021 U.S. Dollars in thousands Contingent consideration (1) 23,534 21,995 Assumed liabilities (2) 61,016 61,915 Less current maturities (29,708 ) (17,986 ) Total Long term Contingent consideration and assumed liabilities $ 54,842 43,929 (1) At December 31, 2022 the fair value of the contingent consideration total $23,534 thousand. The increase in the amount of $1,539 thousands reflects the changes in the value of the liability during 2022 and was recognized as financing expenses in the statement of profit and loss. Through December 31, 2022, no payments were made by the Company on account of the contingent consideration. As of December 31, 2022, the first sales threshold was met and the first milestone payment on account of the contingent consideration is expected to be paid during the first quarter of 2023. Refer to Note 5b and Note 18 for details on the contingent consideration. (2) The assumed liabilities are measured at amortized cost. The decrease in the balance of the assumed liabilities reflects the changes in time value due to and changes in expected payments since the date of acquisition at an amount of $4,727 thousands, net of $5,626 thousands paid during 2022. The increase was recognized as financing expenses in the statement of profit and loss. Refer to Note 5 and Note 16 for details on the assumed liabilities. |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure Of Leases Text Block Abstract | |
Schedule of right-of-use assets composition and changes in lease liabilities | Right-of-use-assets Rented Vehicles Computers, Total Lease (1) U.S Dollars in thousands As of January 1, 2022 $ 2,165 $ 913 $ 15 $ 3,093 $ 4,314 Additions to right-of-use assets - 551 - 551 551 Termination lease - (52 ) - (52 ) (59 ) Depreciation expense (433 ) (583 ) (8 ) (1,024 ) Exchange rate differences - - - - (448 ) Repayment of lease liabilities - - - - (1,164 ) As of December 31, 2022 $ 1,732 $ 829 $ 7 $ 2,568 $ 3,193 (1) The weighted average incremental borrowing rate used to discount future lease payments in the calculation of the lease liability was in the range of 1.94%-4.6% evaluated based on credit risk, terms of the leases and other economic variables. Right-of-use-assets Rented Vehicles Computers, Total Lease (1) U.S Dollars in thousands As of January 1, 2021 $ 2,599 $ 821 $ 20 $ 3,440 $ 4,665 Additions to right -of -use assets 845 845 845 Lease termination (125 ) (125 ) (125 ) Depreciation expense (433 ) (628 ) (5 ) (1,068 ) Exchange rate differences 150 Repayment of lease liabilities (1,221 ) As of December 31, 2021 $ 2,165 $ 913 $ 15 $ 3,093 $ 4,314 (1) The weighted average incremental borrowing rate used to discount future lease payments in the calculation of the lease liability was in the range of 1.75%-4.6% evaluated based on credit risk, terms of the leases and other economic variables. |
Schedule of maturity analysis of lease liabilities | Less than 1 to 2 2 to 3 3 to 5 6 and Total Lease liabilities (including interest) $ 1,119 $ 907 $ 732 $ 683 $ - $ 3,441 Less than 1 to 2 2 to 3 3 to 5 6 and Total Lease liabilities (including interest) $ 1,307 $ 1,100 $ 849 $ 1,485 $ 31 $ 4,772 |
Financial Instruments (Tables)
Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure Of Financial Instruments Text Block Abstract | |
Schedule of classification of financial assets and liabilities | December 31, 2022 2021 U.S. Dollars in thousands Financial assets Financial assets at fair value through other comprehensive income: Cash flow hedges - 73 Total Financial assets at fair value through other comprehensive income: $ - $ 73 Financial assets at cost: Cash and cash equivalent 34,258 18,587 Total Financial assets at cost $ 34,258 $ 18,587 Total financial assets $ 34,160 $ 18,660 Financial liabilities Financial liabilities at fair value through profit or loss: Cash flow hedges 92 Contingent consideration in business combination 23,534 21,995 Foreign exchange forward contracts $ - $ - 23,626 21,995 Financial liabilities measured at amortized cost: Assumed liabilities through business combination 61,016 61,915 Bank loans 17,407 20,038 Leases 3,193 4,314 Total Financial liabilities measured at amortized cost: $ 81,616 $ 86,267 Total financial and lease liabilities $ 105,242 $ 108,262 |
Schedule of maturity profile of company's financial liabilities based on contractual undiscounted payments | Less than 1 to 2 2 to 3 3 to 5 6 and Total Trade payables $ 32,917 - - - - 32,917 Assumed liabilities (1) 23,708 5,030 4,087 7,928 20,263 61,016 Other accounts payables 7,585 - - - - 7,585 Bank loans (including interest) 4,841 4,677 4,580 4,111 - 18,208 Lease liabilities (including interest) 1,119 907 732 683 - 3,441 $ 70,170 10,614 9,399 12,722 20,263 123,167 (1) Due the nature of the account which include infinite payments for royalties and milestones to third party the assumed liabilities reflect the discounted amount. see Note 18e Less than 1 to 2 2 to 3 3 to 5 6 and Total Trade payables $ 25,104 - - - - $ 25,104 Assumed liabilities 17,986 11,203 4,671 7,598 20,457 61,915 Other accounts payables 7,142 - - - - 7,142 Bank loans (including interest) 3,049 4,773 4,677 8,689 - 21,188 Lease liabilities (including interest) 1,307 1,100 849 1,485 31 4,772 $ 54,588 $ 17,076 $ 10,197 $ 17,772 $ 20,488 $ 120,121 |
Schedule of changes in liabilities arising from financing activities | January 1, Payments Foreign New Business Revaluation Write off December 31, U.S. Dollars in thousands Contingent consideration (1) 21,995 - - - - 1,539 - 23,534 Assumed liabilities 61,915 (5,626 ) - - - 4,727 - 61,016 Bank loans $ 20,038 (2,628 ) (2 ) - - - - $ 17,408 Leases 4,314 (1,164 ) (448 ) 551 - - (59 ) 3,193 Total $ 108,262 $ (9,418 ) $ (450 ) $ 551 $ - $ 6,266 $ (59 ) $ 105,152 (1) The contingent consideration fair value as of December 31, 2022 was based on an Option Pricing Method (OPM), “Monte Carlo Simulation” model. In measuring the contingent consideration liability, the Company used an appropriate risk-adjusted discount rate of 11.8 % and volatility of 14.21 %. totaled $23,534 thousands. |
Schedule of carrying amount and fair value of financial instruments | Carrying Amount Fair Value December 31, December 31, 2022 2021 2022 2021 U.S. Dollars in thousands Assumed liabilities 61,016 61,915 56,946 61,915 Bank loans 17,408 20,038 17,071 19,502 Leases 3,193 4,314 3,183 4,608 Total Financial liabilities $ 81,617 $ 86,267 $ 77,200 $ 86,025 |
Schedule of financial assets (liabilities) measured at fair value | Financial assets (liabilities) measured at fair value: Level 1 Level 2 Level 3 (1) U.S. Dollars in thousands December 31, 2022 Derivatives instruments - (92 ) - Contingent consideration(1) - - (23,534 ) $ - $ (92 ) $ (23,534 ) Financial assets (liabilities) measured at fair value: Level 1 Level 2 Level 3 (1) U.S. Dollars in thousands December 31, 2021 Derivatives instruments - 73 - Contingent consideration(1) - - (21,995 ) $ - $ 73 $ (21,995 ) (1) For changes in Contingent liability see above |
Schedule of sensitivity analysis for market risks | December 31, 2022 2021 U.S. Dollars in thousands Sensitivity test to changes in interest rate risk Gain (loss) from change: 1% increase in basis points of SOFR $ (13 ) $ (23 ) 1% decrease in basis points of SOFR $ 13 $ 22 Sensitivity test to changes in foreign currency: Gain (loss) from change: 5% increase in NIS $ (57 ) $ (30 ) 5% decrease in NIS $ 57 $ 30 5% increase in Euro $ (389 ) $ (450 ) 5% decrease in Euro $ 389 $ 450 |
Schedule of linkage terms of financial liabilities by groups of financial instruments | December 31, 2022 2021 U.S. Dollars in thousands In NIS: Bank loans measured at amortized cost $ - $ 38 Leases measured at amortized cost 3,193 4,314 $ 3,193 $ 4,352 In USD: Contingent consideration at fair value through profit or loss 23,534 21,995 Assumed liabilities measured at amortized cost 61,016 61,915 Bank loans measured at amortized cost 17,407 20,000 $ 101,957 $ 103,910 |
Employee Benefit Liabilities,_2
Employee Benefit Liabilities, Net (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure of information about defined benefit plans [abstract] | |
Schedule of expenses recognized in comprehensive income (loss) | Year Ended December 31, 2022 2021 2020 U.S. Dollars in thousands Current service cost $ 223 $ 281 $ 264 Past service cost - 415 - Interest expenses, net 21 23 23 Total employee benefit expenses 237 716 287 Actual return on plan assets $ (25 ) $ 349 $ 35 |
Schedule of expenses presented in statement of comprehensive income (loss) | Year Ended December 31, 2022 2021 2020 U.S. Dollars in thousands Cost of revenues $ 166 $ 499 $ 195 Research and development 24 90 45 Selling and marketing 27 62 22 General and administrative 21 65 25 $ 238 $ 716 $ 287 |
Schedule of plan liabilities, net | December 31, 2022 2021 U.S. Dollars in thousands Defined benefit obligation $ 4,379 $ 5,434 Fair value of plan assets 3,707 4,154 Total liabilities, net $ 672 $ 1,280 |
Schedule of changes in present value of defined benefit obligation | 2022 2021 U.S. Dollars in thousands Balance at January 1, $ 5,434 $ 5,606 Interest costs 78 84 Current service cost 223 281 Past service cost 0 415 Benefits paid (202 ) (1,309 ) Demographic assumptions (9 ) (10 ) Financial assumptions (715 ) (33 ) Past Experience 206 149 Currency Exchange (636 ) 165 Balance at December 31, $ 4,379 $ 5,434 |
Schedule of changes in fair value of plan assets | 2022 2021 U.S. Dollars in thousands Balance at January 1, $ 4,154 $ 4,200 Expected return 62 62 Contributions by employer 181 189 Benefits paid (181 ) (780 ) Demographic assumptions 0 0 Financial assumptions (4 ) 0 Past Experience (20 ) 362 Currency exchange (485 ) 121 Balance at December 31, $ 3,707 $ 4,154 |
Schedule of principal assumptions underlying defined benefit plan | 2022 2021 2020 % Discount rate of the plan liability 5.10 3.1 1.8 Future salary increases 3.0 3.0 3.0 |
Equity (Tables)
Equity (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure of classes of share capital [Abstract] | |
Schedule of share capital | December 31, 2022 December 31, 2021 Authorized Outstanding Authorized Outstanding Ordinary shares of NIS 1 par value 70,000,000 44,832,843 70,000,000 44,799,794 |
Schedule of movement in share capital | Number of shares Balance as of January 1, 2021 44,742,963 Issue of shares - Exercise of options into shares 4,293 Vesting of restricted shares 52,538 Balance as of December 31, 2021 44,799,794 Issue of shares - Exercise of options into shares 1,421 Vesting of restricted shares 31,628 Balance as of December 31, 2022 44,832,843 |
Share-Based Payment (Tables)
Share-Based Payment (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure Of Share Based Payment Arrangements Text Block Abstract | |
Schedule of expense recognized in financial statements | For the Year Ended December 31 2022 2021 2020 U.S. Dollar in thousands Cost of revenues $ 308 $ 69 $ 244 Research and development 204 79 184 Selling and marketing 254 34 39 General and administrative 372 347 510 Total share-based compensation $ 1,138 $ 529 $ 977 |
Schedule of change of awards | 2022 2021 2020 Number of Weighted Number of Weighted Number of Weighted In NIS In NIS In NIS Outstanding at beginning of year 1,504,678 20.38 1,660,958 20.38 2,336,554 27.87 Granted 2,076,800 19.27 - - 382,000 24.36 Exercised (8,325 ) 16.47 (28,672 ) 16.93 (449,093 ) 18.49 Forfeited (325,339 ) 19.14 (127,608 ) 20.29 (608,503 ) 51.68 Outstanding at end of year 3,247,814 19.91 1,504,678 20.65 1,660,958 20.38 Exercisable at end of year 1,049,329 20.38 1,067,363 19.78 799,640 18.97 The weighted average remaining contractual life for the share options 4.67 3.33 4.18 |
Schedule of number of RSs and modification in employee RSs | Number of RSs 2022 2021 2020 Outstanding at beginning of year 49,561 104,519 145,896 Granted - - 30,000 End of restriction period (31,608 ) (52,538 ) (58,328 ) Forfeited (3,248 ) (2,420 ) (13,049 ) Outstanding at end of year 14,105 49,561 104,519 The weighted average remaining contractual life for the restricted share 0.96 3.40 4.39 |
Schedule of inputs to binomial model used for fair value measurement | 2022 (1) 2021 2020 Dividend yield (%) - - - Expected volatility of the share prices (%) 23-40 - 30-55 Risk-free interest rate (%) 0.4-3.55 - 0.01 – 0.58 Contractual term of up to (years) 6.5 - 6.5 Exercise multiple 2 - 2 Weighted average share prices (NIS) 13.6-18.41 - 20.28-28.98 Expected average forfeiture rate (%) 0-8.5 - 1.9-5.9 (1) During the year ended December 31, 2022, no grants of options or RS were made 2022 2021 2020 Dividend yield (%) - - - Expected volatility of the share prices (%) 27-47 - - Risk-free interest rate (%) 0.91-3.54 - - Contractual term of up to (years) 6.5 - - Exercise multiple - - - Weighted average share prices (NIS) 4.8-5.37 - - Expected average forfeiture rate (%) 1.9-8.5 - - |
Taxes on Income (Tables)
Taxes on Income (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure Of Income Tax Text Block 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 tax liabilities and assets | Statements of Year ended December 31, 2022 2021 2020 U.S Dollars in thousands Deferred tax assets: Carryforward tax losses - - (1,330 ) Employee benefits Deferred tax income (expenses) - - (1,330 ) Deferred tax assets, net |
Schedule of current taxes on income | Year ended December 31, 2022 2021 2020 U.S. Dollars in thousands Current taxes $ 62 $ 345 $ 95 Deferred tax expenses (income) - - 1,330 Taxes in respect of prior years - - Taxes on income $ 62 345 $ 1,425 |
Schedule of reconciliation of taxes on profit loss | Year ended 2020 U.S. Dollars in Gain before taxes on income $ 18,565 Statutory tax rate 23 % Tax calculated using the statutory tax rate 4,270 Increase (decrease) in taxes resulting from permanent differences - the tax effect: Adjustment of deferred tax balances following a change in tax rates Taxable income with preferred income tax rates by virtue of the Encouragement Law (3,082 ) Tax exempt income, income subject to special tax rates and nondeductible expenses and other (303 ) Difference between measurement basis of income/expenses for tax purposes and measurement basis of income/expenses for financial reporting purposes 441 Increase in unrecognized tax losses in the year - Prior year taxes - Other 99 Tax on income $ 1,425 Effective tax rate 7.7 % |
Supplementary Information to _2
Supplementary Information to the Statements of Profit and Loss (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure Of Supplementary Information To Statements Of Comprehensive Loss Explanatory Abstract | |
Schedule of additional information about revenues | Year Ended December 31, 2022 2021 2020 U.S. Dollars in thousands Revenues from major customers each of whom amount to 10% or more, of total revenues Customer A (1) 16,195 11,947 18,290 Customer B (2) $ 14,205 $ 31,936 $ 65,081 Customer C (3) 12,255 12,357 13,793 $ 42,655 $ 56,240 $ 97,164 (2) Revenue is attributed to the Proprietary segment. Refer to Note 18 (a) for more information. (3) Revenue is attributed mainly to the Distribution segment. |
Schedule of revenues based on location of customers | Year Ended December 31, 2022 2021 2020 U.S. Dollars in thousands U.S.A and North America $ 75,851 $ 49,763 $ 84,949 Israel 32,031 35,774 36,144 Europe 5,277 5,677 4,461 Latin America 11,293 9,127 6,867 Asia 4,581 3,167 766 Others 305 134 59 Total Revenue $ 129,338 $ 103,642 $ 133,246 |
Schedule of income and expenses | Year Ended December 31, 2022 2021 2020 U.S. Dollars in thousands Cost of materials (1) $ 53,666 $ 63,945 $ 54,745 Salary and related expenses (2) 14,967 17,486 17,957 Subcontractors 4,673 4,892 4,876 Depreciation and amortization (3) 8,553 3,627 3,248 Energy 1,365 1,464 1,626 Other manufacturing expenses 1,785 1,298 575 85,009 92,712 83,027 Decrease (increase) in inventories (2,373 ) (19,398 ) 2,667 Total Cost of goods sold $ 82,636 $ 73,314 $ 85,694 (1) Costs of materials for the year ended December 31, 2021, includes $24,282 of inventory obtained in connection with the business combination. Refer to Note 5b for further detail on the business combination. (2) Reduction of salary and related expenses was attributable to the 2022 labor strike. (3) Including amortization of intangible assets in the amount of $5,376, $574, and $0 for the years ended December 31, 2022, 2021 and 2020, respectively Year Ended December 31, 2022 2021 2020 U.S. Dollars in thousands Salary and related expenses $ 5,608 $ 5,076 $ 6,045 Subcontractors 4,216 3,656 4,794 Materials and allocation of facility costs 2,538 1,896 1,682 Depreciation and amortization 574 616 725 Others 236 113 363 Total Research and development $ 13,172 $ 11,357 $ 13,609 Year Ended December 31, 2022 2021 2020 U.S. Dollars in thousands Salary and related expenses $ 4,047 1,930 1,639 Marketing support 668 136 144 Packing, shipping and delivery 1,484 912 750 Marketing and advertising 2,812 1,193 586 Registration and marketing fees 3,463 1,262 934 Depreciation and amortization (1) 2,056 488 147 Others 754 357 318 Total Selling and marketing $ 15,284 $ 6,278 $ 4,518 (1) Including amortization of intangible assets in the amount of $1,807, $265, and $0 for the years ended December 31, 2022, 2021 and 2020, respectively Year Ended December 31, 2022 2021 2020 U.S. Dollars in thousands Salary and related expenses $ 4,455 $ 3,853 3,870 Employees welfare 1,299 1,259 978 Professional fees and public company expense 4,213 5,055 3,135 Depreciation, amortization and impairment 973 875 779 Communication and software services 905 977 924 Others 958 617 453 Total General and administrative $ 12,803 $ 12,636 $ 10,139 Year Ended December 31, 2022 2021 2020 U.S. Dollars in thousands Financial income Interest income and gains from marketable securities $ 91 $ 295 $ 1,027 Financial expense Revaluation of long term liabilities (6,266 ) (994 ) - Fees and interest paid to financial institutions (914 ) (283 ) (266 ) Financial income and (expense) Derivatives instruments measured at fair value 548 (565 ) (1,097 ) Translation differences of financial assets and liabilities (250 ) 358 (438 ) Bond securities measured at fair value - - 102 Total Financial (expense) income $ (6,791 ) $ (1,189 ) $ (672 ) |
Income (Loss) Per Share (Tables
Income (Loss) Per Share (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure Of Earnings Per Share Text Block Abstract | |
Schedule of details of number of shares and income (loss) | Year Ended December 31, 2022 2021 2020 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 U.S. Dollars U.S. Dollars U.S. Dollars For the computation of basic income (loss) 44,815,248 (2,321 ) 44,771,766 $ (2,230 ) 44,140,771 $ 17,140 Effect of potential dilutive ordinary shares 41,328 130,177 - 449,107 - For the computation of diluted income (loss) 44,856,576 (2,321 ) 44,901,943 $ (2,230 ) 44,589,878 $ 17,140 |
Operating Segments (Tables)
Operating Segments (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure Of Entitys Operating Segments Text Block Abstract | |
Schedule of reporting on operating segments | Proprietary Distribution Total U.S. Dollars in thousands Year Ended December 31, 2022 Revenues $ 102,598 26,741 129,339 Gross profit $ 44,369 2,334 46,703 Unallocated corporate expenses (42,171 ) Finance income, net (6,791 ) Income before taxes on income (2,259 ) Proprietary Distribution Total U.S Dollars in thousands Year Ended December 31, 2021 Revenues $ 75,521 $ 28,121 $ 103,642 Gross profit $ 27,327 $ 3,001 $ 30,328 Unallocated corporate expenses (31,024 ) Finance income, net (1,189 ) Income before taxes on income $ (1,885 ) Proprietary Distribution Total U.S. Dollars in thousand Year Ended December 31, 2020 Revenues $ 100,916 $ 32,330 $ 133,246 Gross profit $ 43,166 $ 4,386 $ 47,552 Unallocated corporate expenses (28,315 ) Finance expense, net (672 ) Loss before taxes on income $ 18,565 |
Balances and Transactions wit_2
Balances and Transactions with Related Parties (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure of related party [Abstract] | |
Schedule of balances with related parties | December 31, December 31, U.S. Dollars in thousands Trade receivable $ 544 $ 1,295 Other accounts payables $ 186 $ 101 |
Schedule of transactions with employed/directors that accounts as related parties | Year Ended December 31, 2022 2021 2020 U.S. Dollars in thousands Remuneration of directors not employed by the Company or on its behalf $ 331 $ 487 $ 506 Number of People to whom the Salary and remuneration Refer: Directors not employed by the Company 9 9 9 Total Directors employed and not employed by the Company 9 9 9 |
Schedule of transactions with key executive personnel | Year Ended December 31, 2022 2021 2020 U.S. Dollars in thousands Salary and Related Expenses $ 3,590 $ 2,791 $ 3,237 Share-based payment 547 255 457 Total $ 4,137 $ 3,046 $ 3,694 |
Schedule of transactions with related parties | Year Ended December 31, 2022 2021 2020 U.S. Dollars in thousands Revenues $ 5,298 $ 5,356 $ 3,899 Cost of Goods Sold $ 19 $ 51 $ 255 Selling and marketing expenses $ 0 $ 0 $ 0 General and administrative expenses $ 214 $ 227 $ 522 |
General (Details)
General (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Disclosure of General Information About Financial Statements Text Block [Abstract] | |
Agreement on initiation of sales, description | Company ceased the production and sale of GLASSIA to Takeda during 2021, and during the first quarter of 2022, Takeda began to pay the Company royalties on sales of GLASSIA manufactured by Takeda, 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. |
Number of operating segments | 2 |
Subsidiary ownership interest, percentage | 74% |
Cost of revenues | $ 4,259 |
Overhead cost charges | 3,999 |
Loss of in-process materials | $ 260 |
Significant Accounting Polici_3
Significant Accounting Policies (Details) | 1 Months Ended |
Aug. 31, 2022 USD ($) | |
Significant Accounting Policies (Details) [Line Items] | |
Eligible employees, percentage | 100% |
Employee contributions percentage | 3% |
Bottom of range [member] | |
Significant Accounting Policies (Details) [Line Items] | |
Eligible employees | $ 20,500 |
Top of range [member] | |
Significant Accounting Policies (Details) [Line Items] | |
Eligible employees | $ 27,000 |
Significant Accounting Polici_4
Significant Accounting Policies (Details) - Schedule of depreciation of right-of-use asset useful life | 12 Months Ended |
Dec. 31, 2022 | |
Land and Buildings [Member] | |
Significant Accounting Policies (Details) - Schedule of depreciation of right-of-use asset useful life [Line Items] | |
Depreciation percentage for right-of-use asset on straight-line basis | 10% |
Mainly % | 10% |
Vehicles [Member] | |
Significant Accounting Policies (Details) - Schedule of depreciation of right-of-use asset useful life [Line Items] | |
Mainly % | 33% |
Office equipment (i.e. printing and photocopying machines) [Member] | |
Significant Accounting Policies (Details) - Schedule of depreciation of right-of-use asset useful life [Line Items] | |
Depreciation percentage for right-of-use asset on straight-line basis | 20% |
Mainly % | 20% |
Bottom of range [member] | Vehicles [Member] | |
Significant Accounting Policies (Details) - Schedule of depreciation of right-of-use asset useful life [Line Items] | |
Depreciation percentage for right-of-use asset on straight-line basis | 20% |
Top of range [member] | Vehicles [Member] | |
Significant Accounting Policies (Details) - Schedule of depreciation of right-of-use asset useful life [Line Items] | |
Depreciation percentage for right-of-use asset on straight-line basis | 33% |
Significant Accounting Polici_5
Significant Accounting Policies (Details) - Schedule of depreciation of property, plant and equipment useful life | 12 Months Ended | |
Dec. 31, 2022 | ||
Buildings [Member] | ||
Significant Accounting Policies (Details) - Schedule of depreciation of property, plant and equipment useful life [Line Items] | ||
Mainly % | 4% | |
Machinery and equipment [Member] | ||
Significant Accounting Policies (Details) - Schedule of depreciation of property, plant and equipment useful life [Line Items] | ||
Mainly % | 15% | |
Vehicles [Member] | ||
Significant Accounting Policies (Details) - Schedule of depreciation of property, plant and equipment useful life [Line Items] | ||
Depreciation percentage for property, plant and equipment on straight-line basis | 15% | |
Mainly % | 15% | |
Computers, software, equipment and office furniture [Member] | ||
Significant Accounting Policies (Details) - Schedule of depreciation of property, plant and equipment useful life [Line Items] | ||
Mainly % | 33% | |
Leasehold improvements [Member] | ||
Significant Accounting Policies (Details) - Schedule of depreciation of property, plant and equipment useful life [Line Items] | ||
Depreciation percentage for property, plant and equipment on straight-line basis | [1] | |
Mainly % | 10% | |
Bottom of range [member] | Buildings [Member] | ||
Significant Accounting Policies (Details) - Schedule of depreciation of property, plant and equipment useful life [Line Items] | ||
Depreciation percentage for property, plant and equipment on straight-line basis | 2.50% | |
Bottom of range [member] | Machinery and equipment [Member] | ||
Significant Accounting Policies (Details) - Schedule of depreciation of property, plant and equipment useful life [Line Items] | ||
Depreciation percentage for property, plant and equipment on straight-line basis | 10% | |
Bottom of range [member] | Computers, software, equipment and office furniture [Member] | ||
Significant Accounting Policies (Details) - Schedule of depreciation of property, plant and equipment useful life [Line Items] | ||
Depreciation percentage for property, plant and equipment on straight-line basis | 6% | |
Top of range [member] | Buildings [Member] | ||
Significant Accounting Policies (Details) - Schedule of depreciation of property, plant and equipment useful life [Line Items] | ||
Depreciation percentage for property, plant and equipment on straight-line basis | 4% | |
Top of range [member] | Machinery and equipment [Member] | ||
Significant Accounting Policies (Details) - Schedule of depreciation of property, plant and equipment useful life [Line Items] | ||
Depreciation percentage for property, plant and equipment on straight-line basis | 20% | |
Top of range [member] | Computers, software, equipment and office furniture [Member] | ||
Significant Accounting Policies (Details) - Schedule of depreciation of property, plant and equipment useful life [Line Items] | ||
Depreciation percentage for property, plant and equipment on straight-line basis | 33% | |
[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_6
Significant Accounting Policies (Details) - Schedule of intangible assets with indefinite useful lives | 12 Months Ended |
Dec. 31, 2022 | |
Intellectual property [Member] | |
Significant Accounting Policies (Details) - Schedule of intangible assets with indefinite useful lives [Line Items] | |
Amortization method | Straight-line |
Intellectual property [Member] | Bottom of range [member] | |
Significant Accounting Policies (Details) - Schedule of intangible assets with indefinite useful lives [Line Items] | |
Estimated life | 15 years |
Intellectual property [Member] | Top of range [member] | |
Significant Accounting Policies (Details) - Schedule of intangible assets with indefinite useful lives [Line Items] | |
Estimated life | 20 years |
Customer Relations [Member] | |
Significant Accounting Policies (Details) - Schedule of intangible assets with indefinite useful lives [Line Items] | |
Estimated life | 20 years |
Amortization method | Straight-line |
Production agreement [Member] | |
Significant Accounting Policies (Details) - Schedule of intangible assets with indefinite useful lives [Line Items] | |
Estimated life | 6 years |
Amortization method | Straight-line |
Distribution right [Member] | |
Significant Accounting Policies (Details) - Schedule of intangible assets with indefinite useful lives [Line Items] | |
Amortization method | Straight-line over the contract period |
Distribution right [Member] | Bottom of range [member] | |
Significant Accounting Policies (Details) - Schedule of intangible assets with indefinite useful lives [Line Items] | |
Estimated life | 10 years |
Distribution right [Member] | Top of range [member] | |
Significant Accounting Policies (Details) - Schedule of intangible assets with indefinite useful lives [Line Items] | |
Estimated life | 15 years |
Goodwill [Member] | |
Significant Accounting Policies (Details) - Schedule of intangible assets with indefinite useful lives [Line Items] | |
Estimated life | Indefinite |
Amortization method | Not amortized |
Business Combinations (Details)
Business Combinations (Details) - USD ($) | 12 Months Ended | ||||
Mar. 01, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Business Combinations (Details) [Line Items] | |||||
Total consideration | $ 1,654,000 | ||||
Acquisition consideration | 1,404,000 | ||||
Deferred consideration | 210 | ||||
Legal and other consulting fees | $ 140,000 | ||||
Discount rate | 19% | ||||
Deferred inventory | $ 50,000,000 | ||||
Consideration payments due | The Company may be entitled for up to $3,000 thousands credit deductible from the contingent consideration payments due for the years 2023 through 2027, subject to certain conditions as defined in the agreement between the parties. | ||||
Risk- adjusted discount rate | 10.60% | ||||
Volatility rate Percentage | 13.60% | ||||
Contingent consideration total | $ 23,534,000 | $ 21,995,000 | |||
Revenues | $ 129,339,000 | $ 103,642,000 | $ 133,246,000 | ||
Risk-adjusted discount rate | 11.80% | 14.21% | |||
Acquired inventory | $ 14,199,000 | ||||
Inventory installments | 1,500,000 | ||||
Deferred inventory | $ 13,788,000 | ||||
Binding term | 12 years | ||||
Fund transfer | $ 3,786,000 | ||||
Description of fair value | (1)Customer Relations represents its fair value (Level 3) at the Acquisition Date, based on a Multi Period Excess Earnings Method (“MPEEM”). In measuring the Customer Relations, the Company used an appropriate risk-adjusted discount rate of 11% and churn rate of 5%. (2) Intellectual property represents its fair value (Level 3) at the Acquisition Date, based on a Relief from Royalties (“RFRM”) Method. In measuring the Intellectual property, the Company used an appropriate risk-adjusted discount rate of 11% and Royalties rate of 15.2%. (3)Assumed contact manufacturing agreement represents its fair value (Level 3) at the Acquisition Date, based on With and Without method. Under the With and Without method the value of an intangible asset is calculated by comparing the cash-flow in situation where the valued asset is part of the business versus the cash-flow in situation where the asset is not part of the business. | ||||
Fair value of such assumed liabilities description | The fair value of such assumed liabilities at the Acquisition Date was estimated at $47,213 thousand, which was calculated based on the Option Pricing Method (OPM), Monte Carlo Simulation, and discounted cash flow using a discount rate in the range of 2.25 % and 11 % and the volatility of 10.8-14.2 %. Refer to Note 14 and Note 16 for more information. Such assumed liabilities include: ● Royalties:10 % of the annual global net sales of CYTOGAM up to $ 25,000 thousand and 5 % of net sales that are greater than $ 25,000 thousand, in perpetuity; 2% of the annual global net sales of CYTOGAM in perpetuity; and 8 % of the annual global net sales of CYTOGAM for a period of six years following the completion of the technology transfer of the manufacturing of CYTOGAM to the Company, subject to a maximum aggregate of $5,000 thousand per year and the total amount of $30,000 thousand throughout the entire six years period. ● Sales milestones: $1,500 thousand in the event that the annual net sales of CYTOGAM in the United States market exceeds $18,766 thousand during the twelve months period ending June 30, 2022 (such milestone was achieved and the payment is expected to be made during 2023); and $1,500 thousand in the event that the annual net sales of CYTOGAM in the United States market exceeds $18,390 thousand during the twelve months period ending June 30, 2023. ● Milestone: $8,500 thousand upon the receipt of FDA approval for the manufacturing of CYTOGAM at the Company’s manufacturing facility. | ||||
Legal and other consulting fees | $ 1,094,000 | ||||
Fair Value of Hierarchy [Member] | |||||
Business Combinations (Details) [Line Items] | |||||
Total consideration | $ 21,705,000 | $ 21,995,000 | |||
Fair value (Level 3) [Member] | |||||
Business Combinations (Details) [Line Items] | |||||
Risk-adjusted discount rate | 11% | ||||
Business Combination [Member] | |||||
Business Combinations (Details) [Line Items] | |||||
Business combination gross profit , description | the Company entered into an Asset Purchase Agreement with the privately held B&PR of Beaumont, TX, USA, for the acquisition of the FDA registered plasma collection facility as well as certain related rights and assets. | ||||
Revenues | $ 1,539,000 | $ 290,000 | |||
Forecast [Member] | |||||
Business Combinations (Details) [Line Items] | |||||
Acquisition consideration | $ 250,000 | ||||
Kamada Plasma LLC [Member] | |||||
Business Combinations (Details) [Line Items] | |||||
Total consideration | $ 1,614,000 | ||||
risk-adjusted discount rate [Member] | |||||
Business Combinations (Details) [Line Items] | |||||
Risk- adjusted discount rate | 10.50% | ||||
Volatility rate Percentage | 10.60% |
Business Combinations (Detail_2
Business Combinations (Details) - Schedule of acquisition consideration $ in Thousands | Dec. 31, 2021 USD ($) | |
Business Combinations (Details) - Schedule of acquisition consideration [Line Items] | ||
Cash paid | $ 95,000 | |
Contingent consideration liability | 21,705 | [1] |
Deferred consideration | 13,788 | [2] |
Settlement of preexisting relationship | (3,786) | [3] |
Total acquisition cost | 126,707 | |
FDA-Licensed Plasma Collection Center [Member] | ||
Business Combinations (Details) - Schedule of acquisition consideration [Line Items] | ||
Cash paid | 1,404 | |
Payables for acquisition | 210 | [4] |
Total acquisition cost | $ 1,614 | |
[1] Pursuant to the Saol APA, and in addition to the cash paid at closing, the Company agreed to pay up to $50,000 thousand of contingent consideration subject the achievement of sales thresholds for the period commencing on the Acquisition Date and ending on December 31, 2034. The Company may be entitled for up to $3,000 thousands credit deductible from the contingent consideration payments due for the years 2023 through 2027, subject to certain conditions as defined in the agreement between the parties. The contingent consideration totaled $21,705 thousands, which represents its fair value (Level 3) at the Acquisition Date, based on an Option Pricing Method (OPM), “Monte Carlo Simulation” model. In measuring the contingent consideration liability as of the Acquisition Date, the Company used an appropriate risk-adjusted discount rate of 10.6 % and volatility of 13.6%. Pursuant to the Saol APA, the Company acquired inventory valued at $14,199 thousand which will be paid in ten quarterly installments of $1,500 thousand each or the remaining balance at the final installment. Such deferred inventory consideration totaled $13,788 thousand which represents the Fair value (Level 2) at the Acquisition Date. The interest rate used to calculate such fair value was based on the Company’s cost of debt which was estimated based on the long-term bank loan obtained to partially fund the acquisition. Through December 31, 2022, the Company made four quarterly installments on account of such inventory related debt. For further information about the deferred consideration, refer to Note 14b and Note 16. In December 2019, the Company entered into a binding term-sheet for a 12-year contract manufacturing agreement with Saol to manufacture CYTOGAM. Through the Acquisition Date, the Company received a total of $3,786 thousand from Saol to partially fund the technology transfer activities required under such engagement. Such engagement was automatically terminated on the Acquisition Date, and such funds, previously accounted for as deferred revenues, were offset from the acquisition consideration as settlement of preexisting relationship. |
Business Combinations (Detail_3
Business Combinations (Details) - Schedule of fair value of the identifiable assets and liabilities on the acquisition date $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 USD ($) | ||
Business Combinations (Details) - Schedule of fair value of the identifiable assets and liabilities on the acquisition date [Line Items] | ||
Inventories | $ 184 | |
Property, plant and equipment | 82 | |
Intangible assets | 962 | [1] |
Total intangible assets | 1,228 | |
Other current liability | (30) | |
Net identifiable assets | 1,198 | |
Goodwill arising on acquisition | 416 | [2] |
Total acquisition cost | 1,614 | |
Fair Value Adjustment to Inventory [Member] | ||
Business Combinations (Details) - Schedule of fair value of the identifiable assets and liabilities on the acquisition date [Line Items] | ||
Inventories | 22,849 | [3] |
Intangible assets | 121,174 | [4] |
Assumed liability | (47,213) | [5] |
Net identifiable assets | 98,810 | |
Goodwill arising on acquisition | 29,897 | [6] |
Total acquisition cost | $ 126,707 | |
[1]The intangible assets represent the value of the FDA license for the plasma collection facility at fair value (Level 3) at the acquisition date, based on the Greenfield Method. Under such method, the subject intangible asset is valued using a hypothetical cashflow scenario of developing an operating business in an entity that at inception only holds the subject intangible asset. In measuring the FDA license for the plasma collection facility, the Company used an appropriate discount rate of 19%.[2]The goodwill arising as part of the acquisition is attributed to the expected benefits from the synergies of the combination of the Company’s activities and those of the acquired plasma collection facility.[3] Inventory was valued at cost which represent its fair value. |
Business Combinations (Detail_4
Business Combinations (Details) - Schedule of intangible assets $ in Thousands | Dec. 31, 2022 USD ($) | |
Schedule Of Intangible Assets Abstract | ||
Customer Relations | $ 33,514 | [1] |
Intellectual property | 79,141 | [2] |
Assumed contract manufacturing agreement | 8,519 | [3] |
Total Intangible assets | $ 121,174 | |
[1] Customer Relations represents its fair value (Level 3) at the Acquisition Date, based on a Multi Period Excess Earnings Method (“MPEEM”). In measuring the Customer Relations, the Company used an appropriate risk-adjusted discount rate of 11% and churn rate of 5%. Intellectual property represents its fair value (Level 3) at the Acquisition Date, based on a Relief from Royalties (“RFRM”) Method. In measuring the Intellectual property, the Company used an appropriate risk-adjusted discount rate of 11% and Royalties rate of 15.2%. Assumed contact manufacturing agreement represents its fair value (Level 3) at the Acquisition Date, based on With and Without method. Under the With and Without method the value of an intangible asset is calculated by comparing the cash-flow in situation where the valued asset is part of the business versus the cash-flow in situation where the asset is not part of the business. The Company used an appropriate risk-adjusted discount rate of 11%. |
Cash and Cash Equivalents (Deta
Cash and Cash Equivalents (Details) - Bear Interest [Member] | Dec. 31, 2022 | Dec. 31, 2021 |
Cash and Cash Equivalents (Details) [Line Items] | ||
Interest rate on deposits | 0.28% | |
Bottom of range [member] | ||
Cash and Cash Equivalents (Details) [Line Items] | ||
Interest rate on deposits | 2.85% | |
Top of range [member] | ||
Cash and Cash Equivalents (Details) [Line Items] | ||
Interest rate on deposits | 3.80% |
Cash and Cash Equivalents (De_2
Cash and Cash Equivalents (Details) - Schedule of cash and cash equivalents - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | |
Schedule Of Cash And Cash Equivalents Abstract | |||
Cash and deposits for immediate withdrawal | $ 31,411 | $ 15,371 | |
Cash equivalents in NIS deposits | [1] | 2,847 | 3,216 |
Total Cash and Cash Equivalents | $ 34,258 | $ 18,587 | |
[1] The deposits bear interest of 2.85%-3.8% per year, as of December 31, 2022 and 0.28% per year, as of December 31, 2021. |
Trade Receivables, Net (Details
Trade Receivables, Net (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Trade Receivables, Net [Abstract] | |
Due debt amount | $ 18,660 |
Collected amount | $ 372 |
Trade Receivables, Net (Detai_2
Trade Receivables, Net (Details) - Schedule of trade receivables, net - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | |
Schedule Of Trade Receivables Net Abstract | |||
In NIS | $ 9,469 | $ 16,093 | |
In USD | 17,659 | 18,736 | |
Total open accounts | 27,128 | 34,829 | |
Checks receivable | 124 | 333 | |
Trade receivables, gross | 27,252 | 35,162 | |
Less allowance for doubtful accounts | [1] | ||
Total Trade receivables, net | $ 27,252 | $ 35,162 | |
[1]As of December 31, 2022 and 2021 no allowance for doubtful accounts was recognized. |
Trade Receivables, Net (Detai_3
Trade Receivables, Net (Details) - Schedule of analysis of past due but not impaired trade receivables - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Trade Receivables, Net (Details) - Schedule of analysis of past due but not impaired trade receivables [Line Items] | ||
Past due trade receivables | $ 27,252 | $ 35,162 |
Neither Past Due Nor Impaired [Member] | ||
Trade Receivables, Net (Details) - Schedule of analysis of past due but not impaired trade receivables [Line Items] | ||
Past due trade receivables | 22,710 | 33,454 |
Past Due Trade Receivables Up to 30 Days [Member] | ||
Trade Receivables, Net (Details) - Schedule of analysis of past due but not impaired trade receivables [Line Items] | ||
Past due trade receivables | 3,260 | 593 |
Past Due Trade Receivables 31-60 Days [Member] | ||
Trade Receivables, Net (Details) - Schedule of analysis of past due but not impaired trade receivables [Line Items] | ||
Past due trade receivables | 788 | 572 |
Past Due Trade Receivables 61-90 Days [Member] | ||
Trade Receivables, Net (Details) - Schedule of analysis of past due but not impaired trade receivables [Line Items] | ||
Past due trade receivables | 84 | 122 |
Past Due Trade Receivables 91-120 Days [Member] | ||
Trade Receivables, Net (Details) - Schedule of analysis of past due but not impaired trade receivables [Line Items] | ||
Past due trade receivables | 7 | 381 |
Past Due Trade Receivables Over 121 Days [Member] | ||
Trade Receivables, Net (Details) - Schedule of analysis of past due but not impaired trade receivables [Line Items] | ||
Past due trade receivables | $ 402 | $ 40 |
Other Accounts Receivables (Det
Other Accounts Receivables (Details) - Schedule of other accounts receivables - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Schedule Of Other Accounts Receivables Abstract | ||
Prepaid expenses | $ 3,875 | $ 3,992 |
Inventory designated for R&D activities | 3,732 | 4,407 |
Government authorities | 645 | 220 |
Derivatives financial instruments mainly measured at fair value through other comprehensive income | 73 | |
Accrued income | 451 | 173 |
Other | 7 | 7 |
Total Other Accounts Receivables | $ 8,710 | $ 8,872 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Inventories [Abstract] | |||
Impairment of inventories | $ 3,996 | $ 2,982 | $ 1,440 |
Finished products and raw materials | $ 2,942 |
Inventories (Details) - Schedul
Inventories (Details) - Schedule of Inventories - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Schedule of Inventories [Abstract] | ||
Finished products | $ 30,429 | $ 36,270 |
Purchased products | 4,754 | 6,251 |
Work in progress | 12,276 | 8,082 |
Raw materials | 21,326 | 16,820 |
Total Inventories | $ 68,785 | $ 67,423 |
Property, Plant and Equipment_2
Property, Plant and Equipment (Details) | 12 Months Ended | |
Dec. 31, 2022 USD ($) m² | Dec. 31, 2021 USD ($) m² | |
Property, Plant and Equipment (Details) [Line Items] | ||
Area of capitalized leasing rights from israel land administration | 16,880 | |
Plant area | 14,880 | |
Lease period with israel land administration | 2058 | |
Extension option for lease with israel land administration | 49 years | |
Machinery [member] | ||
Property, Plant and Equipment (Details) [Line Items] | ||
Cost of facilities, machinery and equipment | $ | $ 1,043,000 | $ 77,500 |
Property, Plant and Equipment_3
Property, Plant and Equipment (Details) - Schedule of composition and movement of property, plant and equipment - USD ($) $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2022 | Dec. 31, 2021 | ||||
Cost [Member] | |||||
Property, Plant and Equipment (Details) - Schedule of composition and movement of property, plant and equipment [Line Items] | |||||
Balance at beginning | $ 78,568 | $ 74,239 | |||
Additions | 3,801 | 4,329 | |||
Sale and write-off | (2) | ||||
Balance at ending | 82,367 | 78,568 | |||
Accumulated Depreciation [Member] | |||||
Property, Plant and Equipment (Details) - Schedule of composition and movement of property, plant and equipment [Line Items] | |||||
Balance at beginning | 52,261 | 48,560 | |||
Depreciation | 3,951 | 3,701 | |||
Sale and write-off | (2) | ||||
Balance at ending | 56,210 | 52,261 | |||
Depreciated cost | 26,157 | 26,307 | |||
Land and Buildings [Member] | Cost [Member] | |||||
Property, Plant and Equipment (Details) - Schedule of composition and movement of property, plant and equipment [Line Items] | |||||
Balance at beginning | [1] | 34,543 | [2] | 33,658 | |
Additions | 547 | [2] | 885 | [1] | |
Sale and write-off | [2] | ||||
Balance at ending | [2] | 35,090 | 34,543 | [1] | |
Land and Buildings [Member] | Accumulated Depreciation [Member] | |||||
Property, Plant and Equipment (Details) - Schedule of composition and movement of property, plant and equipment [Line Items] | |||||
Balance at beginning | [1] | 21,091 | [2] | 20,049 | |
Depreciation | 1,063 | [2] | 1,042 | [1] | |
Sale and write-off | [2] | ||||
Balance at ending | [2] | 22,154 | 21,091 | [1] | |
Depreciated cost | 12,936 | [2] | 13,451 | [1] | |
Machinery and Equipment [Member] | Cost [Member] | |||||
Property, Plant and Equipment (Details) - Schedule of composition and movement of property, plant and equipment [Line Items] | |||||
Balance at beginning | [1] | 33,439 | [2] | 31,299 | |
Additions | 1,906 | [2] | 2,140 | [1] | |
Sale and write-off | [2] | (2) | |||
Balance at ending | [2] | 35,343 | 33,439 | [1] | |
Machinery and Equipment [Member] | Accumulated Depreciation [Member] | |||||
Property, Plant and Equipment (Details) - Schedule of composition and movement of property, plant and equipment [Line Items] | |||||
Balance at beginning | [1] | 23,804 | [2] | 22,110 | |
Depreciation | 1,691 | [2] | 1,694 | [1] | |
Sale and write-off | [2] | (2) | |||
Balance at ending | [2] | 25,493 | 23,804 | [1] | |
Depreciated cost | 9,850 | [2] | 9,635 | [1] | |
Vehicles [Member] | Cost [Member] | |||||
Property, Plant and Equipment (Details) - Schedule of composition and movement of property, plant and equipment [Line Items] | |||||
Balance at beginning | 31 | 31 | |||
Additions | |||||
Sale and write-off | |||||
Balance at ending | 31 | 31 | |||
Vehicles [Member] | Accumulated Depreciation [Member] | |||||
Property, Plant and Equipment (Details) - Schedule of composition and movement of property, plant and equipment [Line Items] | |||||
Balance at beginning | 23 | 20 | |||
Depreciation | 3 | 3 | |||
Sale and write-off | |||||
Balance at ending | 26 | 23 | |||
Depreciated cost | 5 | 8 | |||
Computers, Software, Equipment and Office Furniture [Member] | Cost [Member] | |||||
Property, Plant and Equipment (Details) - Schedule of composition and movement of property, plant and equipment [Line Items] | |||||
Balance at beginning | 9,371 | 8,112 | |||
Additions | 966 | 1,260 | |||
Sale and write-off | |||||
Balance at ending | 10,337 | 9,371 | |||
Computers, Software, Equipment and Office Furniture [Member] | Accumulated Depreciation [Member] | |||||
Property, Plant and Equipment (Details) - Schedule of composition and movement of property, plant and equipment [Line Items] | |||||
Balance at beginning | 6,808 | 5,961 | |||
Depreciation | 1,074 | 847 | |||
Sale and write-off | |||||
Balance at ending | 7,882 | 6,808 | |||
Depreciated cost | 2,455 | 2,563 | |||
Leasehold Improvements [Member] | Cost [Member] | |||||
Property, Plant and Equipment (Details) - Schedule of composition and movement of property, plant and equipment [Line Items] | |||||
Balance at beginning | 1,184 | 1,139 | |||
Additions | 382 | 45 | |||
Sale and write-off | |||||
Balance at ending | 1,566 | 1,184 | |||
Leasehold Improvements [Member] | Accumulated Depreciation [Member] | |||||
Property, Plant and Equipment (Details) - Schedule of composition and movement of property, plant and equipment [Line Items] | |||||
Balance at beginning | 535 | 420 | |||
Depreciation | 120 | 115 | |||
Sale and write-off | |||||
Balance at ending | 655 | 535 | |||
Depreciated cost | $ 911 | $ 649 | |||
[1] Including labor costs charged in 2021 to the cost of facilities, machinery, and equipment in the amount of $775 thousands. Including labor costs charged in 2022 to the cost of facilities, machinery, and equipment in the amount of $1,043 thousands. |
Property, Plant and Equipment_4
Property, Plant and Equipment (Details) - Schedule of leasing rights of land from israel land administration - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Schedule Of Leasing Rights Of Land From Israel Land Administration Abstract | ||
Under finance lease | $ 1,119 | $ 1,150 |
Intangible Assets, Goodwill a_3
Intangible Assets, Goodwill and Other Long Term Assets (Details) | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Intangible Assets, Goodwill and Other Long Term Assets (Details) [Line Items] | |
Carrying amount percentage | 20% |
Carrying amount of goodwill (in Dollars) | $ 30,313 |
Estimated future cash flows | 5 years |
weighted-average cost of capital | 12.10% |
Growth rate | 1% |
Discount rate | 1% |
Bottom of range [member] | |
Intangible Assets, Goodwill and Other Long Term Assets (Details) [Line Items] | |
Proprietary products segments (in Dollars) | $ 4,000 |
Top of range [member] | |
Intangible Assets, Goodwill and Other Long Term Assets (Details) [Line Items] | |
Proprietary products segments (in Dollars) | $ 19,000 |
Intangible Assets, Goodwill a_4
Intangible Assets, Goodwill and Other Long Term Assets (Details) - Schedule of other long term assets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Schedule Of Other Long Term Assets Abstract | ||
Intangible Assets and Goodwill | $ 147,009 | $ 153,592 |
Long term pre-paid expenses | 63 | 71 |
Total Other Long-Term Assets | $ 147,072 | $ 153,663 |
Intangible Assets, Goodwill a_5
Intangible Assets, Goodwill and Other Long Term Assets (Details) - Schedule of composition and movement - USD ($) $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | ||
Cost [Member] | |||||
Intangible Assets, Goodwill and Other Long Term Assets (Details) - Schedule of composition and movement [Line Items] | |||||
Balance as of begining | $ 154,431 | ||||
Purchases | 600 | ||||
Balance as of ending | 155,031 | $ 155,031 | $ 154,431 | ||
Cost [Member] | Intellectual property [Member] | |||||
Intangible Assets, Goodwill and Other Long Term Assets (Details) - Schedule of composition and movement [Line Items] | |||||
Balance as of begining | 80,103 | ||||
Balance as of ending | 80,103 | 80,103 | 80,103 | ||
Cost [Member] | Customer Relationships [Member] | |||||
Intangible Assets, Goodwill and Other Long Term Assets (Details) - Schedule of composition and movement [Line Items] | |||||
Balance as of begining | 33,514 | ||||
Balance as of ending | 33,514 | 33,514 | 33,514 | ||
Cost [Member] | Goodwill [Member] | |||||
Intangible Assets, Goodwill and Other Long Term Assets (Details) - Schedule of composition and movement [Line Items] | |||||
Balance as of begining | 30,313 | ||||
Balance as of ending | 30,313 | 30,313 | 30,313 | ||
Cost [Member] | Other Intangibles [Member] | |||||
Intangible Assets, Goodwill and Other Long Term Assets (Details) - Schedule of composition and movement [Line Items] | |||||
Balance as of begining | [1] | 10,501 | |||
Purchases | [1] | 600 | |||
Balance as of ending | [1] | 11,101 | 11,101 | 10,501 | |
Accumulated amortization and impairment [Member] | |||||
Intangible Assets, Goodwill and Other Long Term Assets (Details) - Schedule of composition and movement [Line Items] | |||||
Balance as of begining | 839 | ||||
Amortization recognized in the year | 7,183 | ||||
Balance as of ending | 8,022 | 8,022 | |||
Amortized cost at December 31, 2022 | 147,009 | 147,009 | |||
Accumulated amortization and impairment [Member] | Intellectual property [Member] | |||||
Intangible Assets, Goodwill and Other Long Term Assets (Details) - Schedule of composition and movement [Line Items] | |||||
Balance as of begining | 477 | ||||
Amortization recognized in the year | 5,376 | ||||
Balance as of ending | 5,853 | 5,853 | |||
Amortized cost at December 31, 2022 | 74,250 | 74,250 | |||
Accumulated amortization and impairment [Member] | Customer Relationships [Member] | |||||
Intangible Assets, Goodwill and Other Long Term Assets (Details) - Schedule of composition and movement [Line Items] | |||||
Balance as of begining | 179 | ||||
Amortization recognized in the year | 1,676 | ||||
Balance as of ending | 1,855 | 1,855 | |||
Amortized cost at December 31, 2022 | 31,659 | 31,659 | |||
Accumulated amortization and impairment [Member] | Goodwill [Member] | |||||
Intangible Assets, Goodwill and Other Long Term Assets (Details) - Schedule of composition and movement [Line Items] | |||||
Balance as of begining | |||||
Amortization recognized in the year | |||||
Balance as of ending | |||||
Amortized cost at December 31, 2022 | 30,313 | 30,313 | |||
Accumulated amortization and impairment [Member] | Other Intangibles [Member] | |||||
Intangible Assets, Goodwill and Other Long Term Assets (Details) - Schedule of composition and movement [Line Items] | |||||
Balance as of begining | [1] | 183 | |||
Amortization recognized in the year | [1] | 131 | |||
Balance as of ending | [1] | 314 | 314 | ||
Amortized cost at December 31, 2022 | [1] | 10,787 | $ 10,787 | ||
Cost [Member] | |||||
Intangible Assets, Goodwill and Other Long Term Assets (Details) - Schedule of composition and movement [Line Items] | |||||
Balance as of begining | 154,431 | 1,492 | |||
Purchases | 490 | ||||
Business combination (b) | 152,449 | ||||
Balance as of ending | 154,431 | $ 1,492 | |||
Cost [Member] | Intellectual property [Member] | |||||
Intangible Assets, Goodwill and Other Long Term Assets (Details) - Schedule of composition and movement [Line Items] | |||||
Balance as of begining | 80,103 | ||||
Business combination (b) | 80,103 | ||||
Balance as of ending | 80,103 | ||||
Cost [Member] | Customer Relationships [Member] | |||||
Intangible Assets, Goodwill and Other Long Term Assets (Details) - Schedule of composition and movement [Line Items] | |||||
Balance as of begining | 33,514 | ||||
Business combination (b) | 33,514 | ||||
Balance as of ending | 33,514 | ||||
Cost [Member] | Goodwill [Member] | |||||
Intangible Assets, Goodwill and Other Long Term Assets (Details) - Schedule of composition and movement [Line Items] | |||||
Balance as of begining | 30,313 | ||||
Business combination (b) | 30,313 | ||||
Balance as of ending | 30,313 | ||||
Cost [Member] | Other Intangibles [Member] | |||||
Intangible Assets, Goodwill and Other Long Term Assets (Details) - Schedule of composition and movement [Line Items] | |||||
Balance as of begining | [1] | $ 10,501 | 1,492 | ||
Purchases | [1] | 490 | |||
Business combination (b) | [1] | 8,519 | |||
Balance as of ending | [1] | 10,501 | 1,492 | ||
Accumulated amortization and impairment [Member] | |||||
Intangible Assets, Goodwill and Other Long Term Assets (Details) - Schedule of composition and movement [Line Items] | |||||
Balance as of begining | 839 | ||||
Amortization recognized in the year | 839 | ||||
Balance as of ending | 839 | ||||
Amortized cost at December 31, 2022 | 153,592 | ||||
Accumulated amortization and impairment [Member] | Intellectual property [Member] | |||||
Intangible Assets, Goodwill and Other Long Term Assets (Details) - Schedule of composition and movement [Line Items] | |||||
Balance as of begining | 477 | ||||
Amortization recognized in the year | 477 | ||||
Balance as of ending | 477 | ||||
Amortized cost at December 31, 2022 | 79,626 | ||||
Accumulated amortization and impairment [Member] | Customer Relationships [Member] | |||||
Intangible Assets, Goodwill and Other Long Term Assets (Details) - Schedule of composition and movement [Line Items] | |||||
Balance as of begining | 179 | ||||
Amortization recognized in the year | 179 | ||||
Balance as of ending | 179 | ||||
Amortized cost at December 31, 2022 | 33,335 | ||||
Accumulated amortization and impairment [Member] | Goodwill [Member] | |||||
Intangible Assets, Goodwill and Other Long Term Assets (Details) - Schedule of composition and movement [Line Items] | |||||
Balance as of begining | |||||
Amortization recognized in the year | |||||
Balance as of ending | |||||
Amortized cost at December 31, 2022 | 30,313 | ||||
Accumulated amortization and impairment [Member] | Other Intangibles [Member] | |||||
Intangible Assets, Goodwill and Other Long Term Assets (Details) - Schedule of composition and movement [Line Items] | |||||
Balance as of begining | [1] | 183 | |||
Amortization recognized in the year | [1] | 183 | |||
Balance as of ending | [1] | $ 183 | |||
Amortized cost at December 31, 2022 | [1] | $ 10,318 | |||
[1] Includes assumed contract manufacturing agreement and distribution right of certain therapeutic products to be distributed in Israel, subject to IL MOH marketing authorization. The Company was required to make certain upfront and milestone payments on account of such distribution rights. These payments are accounted for as long-term assets through obtaining IL MOH marketing authorization and will subsequently be amortized during the expected distribution right’s useful life. |
Intangible Assets, Goodwill a_6
Intangible Assets, Goodwill and Other Long Term Assets (Details) - Schedule of amortization expenses of intangible assets - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule Of Amortization Expenses Of Intangible Assets Abstract | |||
Cost of Goods sold | $ 5,376 | $ 574 | |
Selling and marketing expenses | 1,807 | 265 | |
Total amortization expenses | $ 7,183 | $ 839 |
Intangible Assets, Goodwill a_7
Intangible Assets, Goodwill and Other Long Term Assets (Details) - Schedule of goodwill to cash-generating units - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Schedule Of Goodwill To Cash Generating Units Abstract | ||
Proprietary | $ 30,313 | $ 30,313 |
Trade Payables (Details) - Sche
Trade Payables (Details) - Schedule of trade payables - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Schedule Of Trade Payables Abstract | ||
Open debts mainly in USD | $ 12,731 | $ 7,354 |
Open debts in EUR | 10,629 | 9,174 |
Open debts in NIS | 9,557 | 8,576 |
Total Trade Payables | $ 32,917 | $ 25,104 |
Other Accounts Payables (Detail
Other Accounts Payables (Details) - Schedule of other accounts payables - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Schedule Of Other Accounts Payables Abstract | ||
Employees and payroll accruals | $ 6,683 | $ 6,348 |
Government grants | 201 | 207 |
Derivatives financial instruments | 92 | |
Accrued Expenses and Others | 609 | 587 |
Total Other Accounts Payables | $ 7,585 | $ 7,142 |
Other Accounts Payables (Deta_2
Other Accounts Payables (Details) - Schedule of financial statements - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Schedule Of Financial Statements Abstract | ||
Current Assets | $ 3 | $ 3 |
Current liability | 201 | 207 |
Royalties paid during the year | ||
Expense (income) carried to profit or loss | $ 29 | $ (29) |
Loans and Financial Liabiliti_3
Loans and Financial Liabilities (Details) $ in Thousands, ₪ in Millions | 1 Months Ended | 12 Months Ended | ||||
Jan. 01, 2023 USD ($) | Jan. 01, 2023 ILS (₪) | Nov. 15, 2021 USD ($) | Dec. 31, 2022 USD ($) | Jun. 16, 2022 | Dec. 31, 2021 USD ($) | |
Loans and Financial Liabilities (Details) [Line Items] | ||||||
Credit facility | $ 40,000 | |||||
Long-term loan | $ 20,000 | |||||
Short-term credit facility | $ 20,000 | |||||
Credit facility percentage | 1.75% | |||||
Commitment fee percentage | 0.20% | |||||
Credit facility | $ 10,000 | ₪ 35 | ||||
Loan and credit facility agreement description | (1)The Shareholder’s Equity shall at no time be less than 30% of the Total Assets; examined on a quarterly basis; (2) The Shareholder’s Equity shall at no time be less than $120,000 thousand; examined on a quarterly basis; (3) The ratio between:(a) the short term financial debt less current maturities of long term debt (in as much as such are included therein); and (b) the Working Capital, as such term is defined in the loan agreement, shall at no time exceed 0.8; examined on a quarterly basis; and (4) The ratio between: (a) the EBITDA as such term is defined in the loan agreement; and (b) the current maturities of long term debt to financial institutions plus out of pocket financial expenses, net, reported in the course of four consecutive quarters immediately preceding the examination date, shall not be less than 1.1 during each of the years 2022 and 2024 and not less than 1.25 in the year 2025 and onwards, examined on an annual basis. | |||||
Contingent consideration total | $ 23,534 | $ 21,995 | ||||
Increase amount of liability | 1,539 | |||||
Increase in changes of time value | 5,626 | |||||
Changes in expected payments | $ 5,626 | |||||
Forecast [Member] | ||||||
Loans and Financial Liabilities (Details) [Line Items] | ||||||
Interest rate | 0.55% | 0.55% | 2.18% | |||
Financing facility | $ 20,000 | |||||
Annual fee percentage | 0.275% | 0.275% | ||||
Bottom of range [member] | ||||||
Loans and Financial Liabilities (Details) [Line Items] | ||||||
Interest rate | 3.15% | |||||
Top of range [member] | ||||||
Loans and Financial Liabilities (Details) [Line Items] | ||||||
Interest rate | 3.55% |
Loans and Financial Liabiliti_4
Loans and Financial Liabilities (Details) - Schedule of loans and financial liabilities - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | |
Schedule Of Loans And Financial Liabilities Abstract | |||
Bank loans | [1] | $ 17,407 | $ 20,038 |
Less current maturities of bank loans | 4,444 | 2,631 | |
Total Long term bank loans | $ 12,963 | $ 17,407 | |
[1] Bank loan |
Loans and Financial Liabiliti_5
Loans and Financial Liabilities (Details) - Schedule of financial liabilities - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | |
Schedule Of Financial Liabilities Abstract | |||
Contingent consideration | [1] | $ 23,534 | $ 21,995 |
Assumed liabilities | [2] | 61,016 | 61,915 |
Less current maturities | (29,708) | (17,986) | |
Total Long term Contingent consideration and assumed liabilities | $ 54,842 | $ 43,929 | |
[1]At December 31, 2022 the fair value of the contingent consideration total $23,534 thousand. The increase in the amount of $1,539 thousands reflects the changes in the value of the liability during 2022 and was recognized as financing expenses in the statement of profit and loss. Through December 31, 2022, no payments were made by the Company on account of the contingent consideration. As of December 31, 2022, the first sales threshold was met and the first milestone payment on account of the contingent consideration is expected to be paid during the first quarter of 2023. Refer to Note 5b and Note 18 for details on the contingent consideration.[2] The assumed liabilities are measured at amortized cost. The decrease in the balance of the assumed liabilities reflects the changes in time value due to and changes in expected payments since the date of acquisition at an amount of $4,727 thousands, net of $5,626 thousands paid during 2022. The increase was recognized as financing expenses in the statement of profit and loss. Refer to Note 5 and Note 16 for details on the assumed liabilities. |
Leases (Details)
Leases (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Leases (Details) [Line Items] | ||
Interest expenses on lease liabilities | $ 148 | $ 253 |
Total cash outflow for leases | $ 1,164 | $ 1,221 |
Extension options term | 3 years | |
Bottom of range [Member] | ||
Leases (Details) [Line Items] | ||
Weighted average rate | 1.94% | 1.75% |
Top of range [Member] | ||
Leases (Details) [Line Items] | ||
Weighted average rate | 4.60% | 4.60% |
Leases (Details) - Schedule of
Leases (Details) - Schedule of right-of-use assets composition and changes in lease liabilities - USD ($) $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2022 | Dec. 31, 2021 | ||||
Leases (Details) - Schedule of right-of-use assets composition and changes in lease liabilities [Line Items] | |||||
Beginning balance | $ 3,093 | $ 3,440 | |||
Additions to right-of-use assets | 551 | 845 | |||
Termination lease | (52) | (125) | |||
Depreciation expense | (1,024) | (1,068) | |||
Ending balance | 2,568 | 3,093 | |||
Rented Offices [Member] | |||||
Leases (Details) - Schedule of right-of-use assets composition and changes in lease liabilities [Line Items] | |||||
Beginning balance | 2,165 | 2,599 | |||
Depreciation expense | (433) | (433) | |||
Exchange rate differences | [1] | ||||
Repayment of lease liabilities | [1] | ||||
Ending balance | 1,732 | 2,165 | |||
Vehicles [Member] | |||||
Leases (Details) - Schedule of right-of-use assets composition and changes in lease liabilities [Line Items] | |||||
Beginning balance | 913 | 821 | |||
Additions to right-of-use assets | 551 | 845 | |||
Termination lease | (52) | (125) | |||
Depreciation expense | (583) | (628) | |||
Ending balance | 829 | 913 | |||
Computers, Software, Equipment and Office Furniture [Member] | |||||
Leases (Details) - Schedule of right-of-use assets composition and changes in lease liabilities [Line Items] | |||||
Beginning balance | 15 | 20 | |||
Additions to right-of-use assets | [1] | ||||
Termination lease | [1] | ||||
Depreciation expense | (8) | (5) | |||
Ending balance | 7 | 15 | |||
Lease Liabilities [Member] | |||||
Leases (Details) - Schedule of right-of-use assets composition and changes in lease liabilities [Line Items] | |||||
Beginning balance | [2] | 4,314 | [1] | 4,665 | |
Additions to right-of-use assets | 551 | 845 | [2] | ||
Termination lease | (59) | (125) | [2] | ||
Exchange rate differences | (448) | 150 | [2] | ||
Repayment of lease liabilities | (1,164) | (1,221) | [2] | ||
Ending balance | [1] | $ 3,193 | $ 4,314 | [2] | |
[1] The weighted average incremental borrowing rate used to discount future lease payments in the calculation of the lease liability was in the range of 1.94%-4.6% evaluated based on credit risk, terms of the leases and other economic variables. The weighted average incremental borrowing rate used to discount future lease payments in the calculation of the lease liability was in the range of 1.75%-4.6% evaluated based on credit risk, terms of the leases and other economic variables. |
Leases (Details) - Schedule o_2
Leases (Details) - Schedule of maturity analysis of lease liabilities - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Leases (Details) - Schedule of maturity analysis of lease liabilities [Line Items] | ||
Lease liabilities (including interest) | $ 3,441 | $ 4,772 |
Less than one year [Member] | ||
Leases (Details) - Schedule of maturity analysis of lease liabilities [Line Items] | ||
Lease liabilities (including interest) | 1,119 | 1,307 |
1 to 2 [Member] | ||
Leases (Details) - Schedule of maturity analysis of lease liabilities [Line Items] | ||
Lease liabilities (including interest) | 907 | 1,100 |
2 to 3 [Member] | ||
Leases (Details) - Schedule of maturity analysis of lease liabilities [Line Items] | ||
Lease liabilities (including interest) | 732 | 849 |
3 to 5 [Member] | ||
Leases (Details) - Schedule of maturity analysis of lease liabilities [Line Items] | ||
Lease liabilities (including interest) | 683 | 1,485 |
6 and thereafter [Member] | ||
Leases (Details) - Schedule of maturity analysis of lease liabilities [Line Items] | ||
Lease liabilities (including interest) | $ 31 |
Financial Instruments (Details)
Financial Instruments (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Derivatives instruments not designated as hedging [Member] | |
Financial Instruments (Details) [Line Items] | |
Fair value of the derivative instruments not designated as hedging | $ 4 |
Open transactions for derivative instruments | 15,379 |
Cash flow hedges [Member] | |
Financial Instruments (Details) [Line Items] | |
Open transactions for derivative instruments | 412 |
Fair value of derivative instrument designated as hedging instrument | 88 |
Other comprehensive income | $ 141 |
“Monte Carlo Simulation” [Member] | |
Financial Instruments (Details) [Line Items] | |
Adjusted discount rate | 11.80% |
Volatility rate | 14.21% |
Fair value total | $ 23,534 |
Financial Instruments (Detail_2
Financial Instruments (Details) - Schedule of classification of financial assets and liabilities - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Financial assets | ||
Financial assets | $ 34,160 | $ 18,660 |
Financial liabilities | ||
Financial and lease liabilities | 105,242 | 108,262 |
Financial Liabilities at Fair Value through Profit or Loss Cash Flow Hedges [member] | ||
Financial liabilities | ||
Financial and lease liabilities | 92 | |
Financial liabilities at fair value through profit or loss: Contingent consideration in business combination [Member] | ||
Financial liabilities | ||
Financial and lease liabilities | 23,534 | 21,995 |
Financial liabilities at fair value through profit or loss: Foreign exchange forward contracts [Member] | ||
Financial liabilities | ||
Financial and lease liabilities | ||
Financial liabilities at fair value through profit or loss, category [member] | ||
Financial liabilities | ||
Financial and lease liabilities | 23,626 | 21,995 |
Financial liabilities measured at amortized cost: Assumed liabilities through business combination [Member] | ||
Financial liabilities | ||
Financial and lease liabilities | 61,016 | 61,915 |
Financial liabilities measured at amortized cost: Bank loans [Member] | ||
Financial liabilities | ||
Financial and lease liabilities | 17,407 | 20,038 |
Financial liabilities measured at amortized cost: Leases [Member] | ||
Financial liabilities | ||
Financial and lease liabilities | 3,193 | 4,314 |
Total Financial liabilities measured at amortized cost [Member] | ||
Financial liabilities | ||
Financial and lease liabilities | 81,616 | 86,267 |
Financial assets at fair value through profit or loss: Cash flow hedges [Member] | ||
Financial assets | ||
Financial assets | 73 | |
Total Financial assets at fair value through other comprehensive income [Member] | ||
Financial assets | ||
Financial assets | 73 | |
Financial assets at cost: Cash and cash equivalent [Member] | ||
Financial assets | ||
Financial assets | 34,258 | 18,587 |
Financial assets at cost - Total Financial assets at cost [Member] | ||
Financial assets | ||
Financial assets | $ 34,258 | $ 18,587 |
Financial Instruments (Detail_3
Financial Instruments (Details) - Schedule of maturity profile of company's financial liabilities based on contractual undiscounted payments - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | ||
Financial Instruments (Details) - Schedule of maturity profile of company's financial liabilities based on contractual undiscounted payments [Line Items] | |||
Trade payables | $ 32,917 | $ 25,104 | |
Assumed liabilities | 61,016 | [1] | 61,915 |
Other accounts payables | 7,585 | 7,142 | |
Bank loans (including interest) | 18,208 | 21,188 | |
Lease liabilities (including interest) | 3,441 | 4,772 | |
Financial liabilities | 123,167 | 120,121 | |
Less than one year [Member] | |||
Financial Instruments (Details) - Schedule of maturity profile of company's financial liabilities based on contractual undiscounted payments [Line Items] | |||
Trade payables | 32,917 | 25,104 | |
Assumed liabilities | 23,708 | [1] | 17,986 |
Other accounts payables | 7,585 | 7,142 | |
Bank loans (including interest) | 4,841 | 3,049 | |
Lease liabilities (including interest) | 1,119 | 1,307 | |
Financial liabilities | 70,170 | 54,588 | |
1 to 2 [Member] | |||
Financial Instruments (Details) - Schedule of maturity profile of company's financial liabilities based on contractual undiscounted payments [Line Items] | |||
Trade payables | |||
Assumed liabilities | 5,030 | [1] | 11,203 |
Other accounts payables | |||
Bank loans (including interest) | 4,677 | 4,773 | |
Lease liabilities (including interest) | 907 | 1,100 | |
Financial liabilities | 10,614 | 17,076 | |
2 to 3 [Member] | |||
Financial Instruments (Details) - Schedule of maturity profile of company's financial liabilities based on contractual undiscounted payments [Line Items] | |||
Trade payables | |||
Assumed liabilities | 4,087 | [1] | 4,671 |
Other accounts payables | |||
Bank loans (including interest) | 4,580 | 4,677 | |
Lease liabilities (including interest) | 732 | 849 | |
Financial liabilities | 9,399 | 10,197 | |
3 to 5 [Member] | |||
Financial Instruments (Details) - Schedule of maturity profile of company's financial liabilities based on contractual undiscounted payments [Line Items] | |||
Trade payables | |||
Assumed liabilities | 7,928 | [1] | 7,598 |
Other accounts payables | |||
Bank loans (including interest) | 4,111 | 8,689 | |
Lease liabilities (including interest) | 683 | 1,485 | |
Financial liabilities | 12,722 | 17,772 | |
6 and thereafter [Member] | |||
Financial Instruments (Details) - Schedule of maturity profile of company's financial liabilities based on contractual undiscounted payments [Line Items] | |||
Trade payables | |||
Assumed liabilities | 20,263 | [1] | 20,457 |
Other accounts payables | |||
Bank loans (including interest) | |||
Lease liabilities (including interest) | 31 | ||
Financial liabilities | $ 20,263 | $ 20,488 | |
[1] Due the nature of the account which include infinite payments for royalties and milestones to third party the assumed liabilities reflect the discounted amount. see Note 18e |
Financial Instruments (Detail_4
Financial Instruments (Details) - Schedule of changes in liabilities arising from financing activities $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 USD ($) | ||
Financial Instruments (Details) - Schedule of changes in liabilities arising from financing activities [Line Items] | ||
Beginning | $ 108,262 | |
Payments | (9,418) | |
Foreign exchange movement | (450) | |
New loans and leases | 551 | |
Business combination | ||
Revaluation | 6,266 | |
Write off | (59) | |
Ending | 105,152 | |
Contingent consideration [Member] | ||
Financial Instruments (Details) - Schedule of changes in liabilities arising from financing activities [Line Items] | ||
Beginning | 21,995 | [1] |
Payments | [1] | |
Foreign exchange movement | [1] | |
New loans and leases | [1] | |
Business combination | [1] | |
Revaluation | 1,539 | [1] |
Write off | [1] | |
Ending | 23,534 | |
Assumed Liabilities [Member] | ||
Financial Instruments (Details) - Schedule of changes in liabilities arising from financing activities [Line Items] | ||
Beginning | 61,915 | |
Payments | (5,626) | |
Foreign exchange movement | ||
Revaluation | 4,727 | |
Write off | ||
Ending | 61,016 | |
Bank loans [Member] | ||
Financial Instruments (Details) - Schedule of changes in liabilities arising from financing activities [Line Items] | ||
Beginning | 20,038 | |
Payments | (2,628) | |
Foreign exchange movement | (2) | |
Business combination | ||
Write off | ||
Ending | 17,408 | |
Leases [Member] | ||
Financial Instruments (Details) - Schedule of changes in liabilities arising from financing activities [Line Items] | ||
Beginning | 4,314 | |
Payments | (1,164) | |
Foreign exchange movement | (448) | |
New loans and leases | 551 | |
Write off | (59) | |
Ending | $ 3,193 | |
[1]The contingent consideration fair value as of December 31, 2022 was based on an Option Pricing Method (OPM), “Monte Carlo Simulation” model. In measuring the contingent consideration liability, the Company used an appropriate risk-adjusted discount rate of 11.8 % and volatility of 14.21 %. totaled $23,534 thousands. |
Financial Instruments (Detail_5
Financial Instruments (Details) - Schedule of carrying amount and fair value of financial instruments - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Financial Instruments (Details) - Schedule of carrying amount and fair value of financial instruments [Line Items] | ||
Financial liabilities Carrying Amount | $ 81,617 | $ 86,267 |
Financial liabilities Fair Value | 77,200 | 86,025 |
Assumed Liabilities [Member] | ||
Financial Instruments (Details) - Schedule of carrying amount and fair value of financial instruments [Line Items] | ||
Financial liabilities Carrying Amount | 61,016 | 61,915 |
Financial liabilities Fair Value | 56,946 | 61,915 |
Bank loans [Member] | ||
Financial Instruments (Details) - Schedule of carrying amount and fair value of financial instruments [Line Items] | ||
Financial liabilities Carrying Amount | 17,408 | 20,038 |
Financial liabilities Fair Value | 17,071 | 19,502 |
Leases [Member] | ||
Financial Instruments (Details) - Schedule of carrying amount and fair value of financial instruments [Line Items] | ||
Financial liabilities Carrying Amount | 3,193 | 4,314 |
Financial liabilities Fair Value | $ 3,183 | $ 4,608 |
Financial Instruments (Detail_6
Financial Instruments (Details) - Schedule of financial assets (liabilities) measured at fair value - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | |
Level 1 [Member] | |||
Financial Instruments (Details) - Schedule of financial assets (liabilities) measured at fair value [Line Items] | |||
Derivatives instruments | |||
Contingent consideration | [1] | ||
Financial assets (liabilities) measured at fair value | |||
Level 2 [Member] | |||
Financial Instruments (Details) - Schedule of financial assets (liabilities) measured at fair value [Line Items] | |||
Derivatives instruments | 73 | ||
Contingent consideration | |||
Financial assets (liabilities) measured at fair value | (92) | 73 | |
Level 3 [Member] | |||
Financial Instruments (Details) - Schedule of financial assets (liabilities) measured at fair value [Line Items] | |||
Derivatives instruments | |||
Contingent consideration | (21,705) | (21,995) | |
Financial assets (liabilities) measured at fair value | [1] | (23,534) | $ (21,995) |
Derivatives instruments [Member] | Level 1 [Member] | |||
Financial Instruments (Details) - Schedule of financial assets (liabilities) measured at fair value [Line Items] | |||
Derivatives instruments | |||
Derivatives instruments [Member] | Level 2 [Member] | |||
Financial Instruments (Details) - Schedule of financial assets (liabilities) measured at fair value [Line Items] | |||
Derivatives instruments | (92) | ||
Derivatives instruments [Member] | Level 3 [Member] | |||
Financial Instruments (Details) - Schedule of financial assets (liabilities) measured at fair value [Line Items] | |||
Derivatives instruments | |||
Contingent consideration [member] | Level 1 [Member] | |||
Financial Instruments (Details) - Schedule of financial assets (liabilities) measured at fair value [Line Items] | |||
Contingent consideration | [1] | ||
Contingent consideration [member] | Level 2 [Member] | |||
Financial Instruments (Details) - Schedule of financial assets (liabilities) measured at fair value [Line Items] | |||
Contingent consideration | |||
Contingent consideration [member] | Level 3 [Member] | |||
Financial Instruments (Details) - Schedule of financial assets (liabilities) measured at fair value [Line Items] | |||
Contingent consideration | $ (23,534) | ||
[1] For changes in Contingent liability see above |
Financial Instruments (Detail_7
Financial Instruments (Details) - Schedule of sensitivity analysis for market risks - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
5% increase in market price [Member] | ||
Financial Instruments (Details) - Schedule of sensitivity analysis for market risks [Line Items] | ||
Gain (loss) from sensitivity test to changes in market price of listed Securities | $ (13) | $ (23) |
5% decrease in market price [Member] | ||
Financial Instruments (Details) - Schedule of sensitivity analysis for market risks [Line Items] | ||
Gain (loss) from sensitivity test to changes in market price of listed Securities | 13 | 22 |
5% increase in NIS [Member] | ||
Financial Instruments (Details) - Schedule of sensitivity analysis for market risks [Line Items] | ||
Gain (loss) from sensitivity test to changes in market price of listed Securities | (57) | (30) |
5% decrease in NIS [Member] | ||
Financial Instruments (Details) - Schedule of sensitivity analysis for market risks [Line Items] | ||
Gain (loss) from sensitivity test to changes in market price of listed Securities | 57 | 30 |
5% increase in Euro [Member] | ||
Financial Instruments (Details) - Schedule of sensitivity analysis for market risks [Line Items] | ||
Gain (loss) from sensitivity test to changes in market price of listed Securities | (389) | (450) |
5% decrease in Euro [Member] | ||
Financial Instruments (Details) - Schedule of sensitivity analysis for market risks [Line Items] | ||
Gain (loss) from sensitivity test to changes in market price of listed Securities | $ 389 | $ 450 |
Financial Instruments (Detail_8
Financial Instruments (Details) - Schedule of linkage terms of financial liabilities by groups of financial instruments - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Financial Instruments (Details) - Schedule of linkage terms of financial liabilities by groups of financial instruments [Line Items] | ||
Total | $ 101,957 | $ 103,910 |
NIS [Member] | ||
Financial Instruments (Details) - Schedule of linkage terms of financial liabilities by groups of financial instruments [Line Items] | ||
Linkage terms of financial liabilities by groups of financial instruments pursuant to IFRS 9 | 3,193 | 4,352 |
Bank loans measured at amortized cost [Member] | NIS [Member] | ||
Financial Instruments (Details) - Schedule of linkage terms of financial liabilities by groups of financial instruments [Line Items] | ||
Linkage terms of financial liabilities by groups of financial instruments pursuant to IFRS 9 | 38 | |
Bank loans measured at amortized cost [Member] | USD [Member] | ||
Financial Instruments (Details) - Schedule of linkage terms of financial liabilities by groups of financial instruments [Line Items] | ||
Linkage terms of financial liabilities by groups of financial instruments pursuant to IFRS 9 | 17,407 | 20,000 |
Leases measured at amortized cost [Member] | NIS [Member] | ||
Financial Instruments (Details) - Schedule of linkage terms of financial liabilities by groups of financial instruments [Line Items] | ||
Linkage terms of financial liabilities by groups of financial instruments pursuant to IFRS 9 | 3,193 | 4,314 |
Contingent consideration at fair value through profit or loss [Member] | USD [Member] | ||
Financial Instruments (Details) - Schedule of linkage terms of financial liabilities by groups of financial instruments [Line Items] | ||
Linkage terms of financial liabilities by groups of financial instruments pursuant to IFRS 9 | 23,534 | 21,995 |
Assumed liabilities measured at amortized cost [Member] | USD [Member] | ||
Financial Instruments (Details) - Schedule of linkage terms of financial liabilities by groups of financial instruments [Line Items] | ||
Linkage terms of financial liabilities by groups of financial instruments pursuant to IFRS 9 | $ 61,016 | $ 61,915 |
Employee Benefit Liabilities,_3
Employee Benefit Liabilities, Net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Employee Benefit Liabilities, Net (Details) [Line Items] | |||
Expenses for defined benefit deposit | $ 873 | $ 1,023 | $ 1,299 |
Contributions amounts | 11 | ||
Actuarial assumption of discount rates [member] | Bottom of range [member] | |||
Employee Benefit Liabilities, Net (Details) [Line Items] | |||
Increase (decrease) in defined benefit obligation from a 1% increase in actuarial assumption | 110 | ||
Actuarial assumption of discount rates [member] | Top of range [member] | |||
Employee Benefit Liabilities, Net (Details) [Line Items] | |||
Increase (decrease) in defined benefit obligation from a 1% decrease in actuarial assumption | 165 | ||
Expected salary growth [Member] | Top of range [member] | |||
Employee Benefit Liabilities, Net (Details) [Line Items] | |||
Increase (decrease) in defined benefit obligation from a 1% increase in actuarial assumption | 158 | ||
Increase (decrease) in defined benefit obligation from a 1% decrease in actuarial assumption | $ 105 |
Employee Benefit Liabilities,_4
Employee Benefit Liabilities, Net (Details) - Schedule of expenses recognized in comprehensive income (loss) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule Of Expenses Recognized In Comprehensive Income Loss Abstract | |||
Current service cost | $ 223 | $ 281 | $ 264 |
Past service cost | 415 | ||
Interest expenses, net | 21 | 23 | 23 |
Total employee benefit expenses | 237 | 716 | 287 |
Actual return on plan assets | $ (25) | $ 349 | $ 35 |
Employee Benefit Liabilities,_5
Employee Benefit Liabilities, Net (Details) - Schedule of expenses presented in statement of comprehensive income (loss) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Employee Benefit Liabilities, Net (Details) - Schedule of expenses presented in statement of comprehensive income (loss) [Line Items] | |||
Total employee benefit expenses | $ 238 | $ 716 | $ 287 |
Cost of revenues [Member] | |||
Employee Benefit Liabilities, Net (Details) - Schedule of expenses presented in statement of comprehensive income (loss) [Line Items] | |||
Total employee benefit expenses | 166 | 499 | 195 |
Research and development [Member] | |||
Employee Benefit Liabilities, Net (Details) - Schedule of expenses presented in statement of comprehensive income (loss) [Line Items] | |||
Total employee benefit expenses | 24 | 90 | 45 |
Selling and marketing [Member] | |||
Employee Benefit Liabilities, Net (Details) - Schedule of expenses presented in statement of comprehensive income (loss) [Line Items] | |||
Total employee benefit expenses | 27 | 62 | 22 |
General and administrative [Member] | |||
Employee Benefit Liabilities, Net (Details) - Schedule of expenses presented in statement of comprehensive income (loss) [Line Items] | |||
Total employee benefit expenses | $ 21 | $ 65 | $ 25 |
Employee Benefit Liabilities,_6
Employee Benefit Liabilities, Net (Details) - Schedule of plan liabilities, net - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Schedule Of Plan Liabilities Net Abstract | ||
Defined benefit obligation | $ 4,379 | $ 5,434 |
Fair value of plan assets | 3,707 | 4,154 |
Total liabilities, net | $ 672 | $ 1,280 |
Employee Benefit Liabilities,_7
Employee Benefit Liabilities, Net (Details) - Schedule of changes in present value of defined benefit obligation - Defined Benefit Obligation [Member] - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Employee Benefit Liabilities, Net (Details) - Schedule of changes in present value of defined benefit obligation [Line Items] | ||
Balance at January 1, | $ 5,434 | $ 5,606 |
Interest costs | 78 | 84 |
Current service cost | 223 | 281 |
Past service cost | 0 | 415 |
Benefits paid | (202) | (1,309) |
Demographic assumptions | (9) | (10) |
Financial assumptions | (715) | (33) |
Past Experience | 206 | 149 |
Currency Exchange | (636) | 165 |
Balance at December 31, | $ 4,379 | $ 5,434 |
Employee Benefit Liabilities,_8
Employee Benefit Liabilities, Net (Details) - Schedule of changes in fair value of plan assets - Plan assets [member] - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Employee Benefit Liabilities, Net (Details) - Schedule of changes in fair value of plan assets [Line Items] | ||
Balance at January 1, | $ 4,154 | $ 4,200 |
Expected return | 62 | 62 |
Contributions by employer | 181 | 189 |
Benefits paid | (181) | (780) |
Demographic assumptions | 0 | 0 |
Financial assumptions | (4) | 0 |
Past Experience | (20) | 362 |
Currency exchange | (485) | 121 |
Balance at December 31, | $ 3,707 | $ 4,154 |
Employee Benefit Liabilities,_9
Employee Benefit Liabilities, Net (Details) - Schedule of principal assumptions underlying defined benefit plan | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Schedule Of Principal Assumptions Underlying Defined Benefit Plan Abstract | |||
Discount rate of the plan liability | 5.10% | 3.10% | 1.80% |
Future salary increases | 3% | 3% | 3% |
Contingent Liabilities and Co_2
Contingent Liabilities and Commitments (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||||||||
Jan. 14, 2021 | Aug. 23, 2010 | Dec. 31, 2019 | Jul. 31, 2019 | Nov. 30, 2006 | Jun. 30, 2023 | Dec. 31, 2022 | Jun. 30, 2022 | Dec. 31, 2021 | Mar. 31, 2021 | |
Contingent Liabilities and Commitments (Details) [Line Items] | ||||||||||
License agreement, description | In addition, upon initiation of sales of GLASSIA manufactured by Takeda, the Company would 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”). | |||||||||
Payments received | $ 2,000 | |||||||||
Royalty income | $ 12,200 | |||||||||
Agreements expiration period | 15 years | |||||||||
Upfront payment | $ 95,000 | |||||||||
Additional payments | 50,000 | |||||||||
Contingent consideration payments | 3,000 | |||||||||
Acquired inventory | 14,200 | |||||||||
Inventory quarterly installments amount | $ 1,500 | |||||||||
Assumed royalties liabilities, description | ●Royalties:10 % of the annual global net sales of CYTOGAM up to $25 million and 5 % of net sales that are greater than $25 million, in perpetuity; 2% of the annual global net sales of CYTOGAM in perpetuity; and, 8% of the annual global net sales of CYTOGAM for period of six years following the completion of the technology transfer of the manufacturing of CYTOGAM to the Company, subject to a maximum aggregate of $5 million per year and for total amount of $30 million throughout the entire six years period. | |||||||||
Manufacturing facility | $ 8,500 | |||||||||
Financing facility | 40,000 | |||||||||
Five-year loan amount | 20,000 | |||||||||
Short-term credit facility | 20,000 | |||||||||
Contract asset | 7,577 | $ 5,561 | ||||||||
Payment to royalties percentage | 24% | |||||||||
Baxter Healthcare Corporation [Member] | ||||||||||
Contingent Liabilities and Commitments (Details) [Line Items] | ||||||||||
Agreement term | 30 years | |||||||||
Agreement payment amount | 45,000 | |||||||||
Amount received from distribution agreement | 45,000 | |||||||||
Clinical studies total amount | $ 10,000 | |||||||||
Patents [Member] | ||||||||||
Contingent Liabilities and Commitments (Details) [Line Items] | ||||||||||
Agreements expiration period | 15 years | |||||||||
Master Clinical Services Agreement [Member] | ||||||||||
Contingent Liabilities and Commitments (Details) [Line Items] | ||||||||||
Agreements expiration period | 7 years | |||||||||
Manufacturing Agreement [Member] | ||||||||||
Contingent Liabilities and Commitments (Details) [Line Items] | ||||||||||
Agreements expiration period | 12 years | |||||||||
Forecast [Member] | ||||||||||
Contingent Liabilities and Commitments (Details) [Line Items] | ||||||||||
Annual net sales | $ 1,500 | $ 1,500 | ||||||||
Market exceeds amount | $ 18,400 | $ 18,800 | ||||||||
Top of Range [Member] | ||||||||||
Contingent Liabilities and Commitments (Details) [Line Items] | ||||||||||
Payments expired date | 2023 | |||||||||
Bottom of Range [Member] | ||||||||||
Contingent Liabilities and Commitments (Details) [Line Items] | ||||||||||
Payments expired date | 2027 |
Guarantees and Charges (Details
Guarantees and Charges (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Guarantees and Charges (Details) [Line Items] | |
Contingent liability | $ 3,000 |
Value of loans for which collateral has been pledged description | the Company secured a debt facility from an Israeli bank (see Note 14) pursuant to which, the Company undertook not to create any first ranking floating charge over all or materially all of its property and assets in favor of any third party unless certain terms, as defined in the loan agreement, have been satisfied. |
Contingent liability for guarantees [member] | |
Guarantees and Charges (Details) [Line Items] | |
Contingent liability | $ 308 |
Equity (Details)
Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Feb. 10, 2020 | Nov. 21, 2019 | Dec. 31, 2022 | Dec. 31, 2021 | |
Disclosure of classes of share capital [Abstract] | ||||
Share options, exercised | 8,325 | 28,672 | ||
Ordinary shares par value of NIS (in Dollars per share) | $ 1 | |||
Ordinary shares of NIS | 1,408 | 4,293 | ||
Number of share options vesteed expired in share | 31,608 | 58,328 | ||
Total consideration exercised (in Dollars) | $ 9 | $ 17 | ||
Issue of ordinary shares, description | FIMI Opportunity Fund 6, L.P. and FIMI Israel Opportunity Fund 6, Limited Partnership (the “FIMI Funds”) acquired 5,240,956 ordinary shares at a price of $6.00, representing ownership of approximately 13% of the Company’s outstanding shares. | |||
Private placement, description | Pursuant to the private placement the Company issued 4,166,667 ordinary shares at a price of $6.00 per share, for total gross proceeds of $25,000 thousands. | |||
Outstanding shares, percentage | 21% |
Equity (Details) - Schedule of
Equity (Details) - Schedule of share capital - shares | Dec. 31, 2022 | Dec. 31, 2021 |
Schedule 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 | 44,832,843 | 44,799,794 |
Equity (Details) - Schedule o_2
Equity (Details) - Schedule of movement in share capital - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Schedule of Movement in Share Capital [Abstract] | ||
Beginning balance | 44,799,794 | 44,742,963 |
Issue of shares | ||
Exercise of options into shares | 1,421 | 4,293 |
Vesting of restricted shares | 31,628 | 52,538 |
Ending balance | 44,832,843 | 44,799,794 |
Share-Based Payment (Details)
Share-Based Payment (Details) $ / shares in Units, $ in Thousands | 12 Months Ended | |||||||||||||||||||
Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares ₪ / shares shares | Feb. 27, 2023 shares | Dec. 31, 2022 ₪ / shares | Dec. 22, 2022 USD ($) shares | Dec. 22, 2022 ₪ / shares | Sep. 01, 2022 USD ($) $ / shares shares | Aug. 23, 2022 shares | May 01, 2022 USD ($) $ / shares shares | Mar. 15, 2022 USD ($) $ / shares shares | Mar. 13, 2022 USD ($) $ / shares shares | Mar. 13, 2022 ₪ / shares | Mar. 01, 2022 USD ($) $ / shares shares | Mar. 01, 2022 ₪ / shares | Feb. 28, 2022 USD ($) $ / shares shares | Feb. 28, 2022 ₪ / shares | Dec. 31, 2021 $ / shares | Dec. 31, 2021 ₪ / shares | Dec. 31, 2020 $ / shares | Dec. 31, 2019 $ / shares | |
Share-Based Payment (Details) [Line Items] | ||||||||||||||||||||
Granted options, percentage | 25% | 25% | ||||||||||||||||||
Option granted | 28,100 | 28,100 | 147,000 | 18,100 | 18,100 | 60,000 | 15,000 | 18,100 | 23,100 | |||||||||||
Exercise price of options | (per share) | $ 5.16 | $ 5.64 | $ 5.88 | $ 5.8 | ₪ 18.92 | $ 6.06 | $ 6.1 | $ 20.38 | $ 20.38 | $ 27.87 | ||||||||||
Fair value of options (in Dollars) | $ | $ 36 | $ 40 | $ 135 | $ 29 | $ 40 | $ 51 | ||||||||||||||
Exercise price range | (per share) | $ 5.36 | ₪ 16.47 | ||||||||||||||||||
Fair value of the options (in Dollars) | $ | $ 59 | ₪ 59 | ||||||||||||||||||
Exercise price (in New Shekels per share) | ₪ / shares | ₪ 20.33 | |||||||||||||||||||
Israeli [Member] | ||||||||||||||||||||
Share-Based Payment (Details) [Line Items] | ||||||||||||||||||||
Option granted | 143,667 | 143,667 | ||||||||||||||||||
Exercise price of options | (per share) | $ 4.5 | ₪ 4.5 | ₪ 16.53 | |||||||||||||||||
Fair value of the options (in Dollars) | $ | $ 89 | ₪ 89 | ||||||||||||||||||
Unites States [Member] | ||||||||||||||||||||
Share-Based Payment (Details) [Line Items] | ||||||||||||||||||||
Option granted | 3,333 | 3,333 | ||||||||||||||||||
Exercise price of options | $ / shares | $ 4.57 | ₪ 4.57 | ||||||||||||||||||
Fair value of the options (in Dollars) | $ | $ 59 | ₪ 59 | ||||||||||||||||||
2011 Option Plan [Member] | ||||||||||||||||||||
Share-Based Payment (Details) [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% on the first anniversary of the grant date and 6.25% at the end of each quarter thereafter. | 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% on the first anniversary of the grant date and 6.25% at the end of each quarter thereafter. | ||||||||||||||||||
Employees and Executive Officers [Member] | ||||||||||||||||||||
Share-Based Payment (Details) [Line Items] | ||||||||||||||||||||
Option granted | 1,327,500 | |||||||||||||||||||
Chief Executive Officer [Member] | ||||||||||||||||||||
Share-Based Payment (Details) [Line Items] | ||||||||||||||||||||
Option granted | 400,000 | 400,000 | ||||||||||||||||||
Exercise price of options | ₪ / shares | ₪ 21.34 | |||||||||||||||||||
Fair value of options (in Dollars) | $ | $ 447 | |||||||||||||||||||
Board of Directors members [Member] | ||||||||||||||||||||
Share-Based Payment (Details) [Line Items] | ||||||||||||||||||||
Option granted | 270,000 | 270,000 | ||||||||||||||||||
Fair value of options (in Dollars) | $ | $ 282 | |||||||||||||||||||
Share-Based Payment Arrangement, Option [Member] | ||||||||||||||||||||
Share-Based Payment (Details) [Line Items] | ||||||||||||||||||||
Option granted | 51,200 | 51,200 | 10,000 | 1,105,100 | ||||||||||||||||
Exercise price of options | (per share) | $ 6.04 | ₪ 19.54 | $ 5.97 | |||||||||||||||||
Fair value of options (in Dollars) | $ | $ 89 | ₪ 89 | $ 20 | $ 2,162 | ||||||||||||||||
Share-Based Payment Arrangement, Option [Member] | Israeli [Member] | ||||||||||||||||||||
Share-Based Payment (Details) [Line Items] | ||||||||||||||||||||
Exercise price of options | ₪ / shares | ₪ 19.36 | |||||||||||||||||||
Board of Directors [Member] | ||||||||||||||||||||
Share-Based Payment (Details) [Line Items] | ||||||||||||||||||||
Option granted | 79,300 | |||||||||||||||||||
Bottom of range [member] | Board of Directors members [Member] | ||||||||||||||||||||
Share-Based Payment (Details) [Line Items] | ||||||||||||||||||||
Exercise price of options | ₪ / shares | ₪ 17.35 | |||||||||||||||||||
Bottom of range [member] | Share-Based Payment Arrangement, Option [Member] | ||||||||||||||||||||
Share-Based Payment (Details) [Line Items] | ||||||||||||||||||||
Exercise price of options | (per share) | $ 5.27 | ₪ 5.27 | ₪ 17.18 |
Share-Based Payment (Details) -
Share-Based Payment (Details) - Schedule of expense recognized in financial statements - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-Based Payment (Details) - Schedule of expense recognized in financial statements [Line Items] | |||
Total share-based compensation | $ 1,138 | $ 529 | $ 977 |
Cost of revenues [Member] | |||
Share-Based Payment (Details) - Schedule of expense recognized in financial statements [Line Items] | |||
Total share-based compensation | 308 | 69 | 244 |
Research and development [Member] | |||
Share-Based Payment (Details) - Schedule of expense recognized in financial statements [Line Items] | |||
Total share-based compensation | 204 | 79 | 184 |
Selling and marketing [Member] | |||
Share-Based Payment (Details) - Schedule of expense recognized in financial statements [Line Items] | |||
Total share-based compensation | 254 | 34 | 39 |
General and administrative [Member] | |||
Share-Based Payment (Details) - Schedule of expense recognized in financial statements [Line Items] | |||
Total share-based compensation | $ 372 | $ 347 | $ 510 |
Share-Based Payment (Details)_2
Share-Based Payment (Details) - Schedule of change of awards - $ / shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of Change of Awards [Abstract] | |||
Number of Options, Outstanding at beginning of year (in Shares) | 1,504,678 | 1,660,958 | 2,336,554 |
Weighted Average Exercise Price, Outstanding at beginning of year | $ 20.38 | $ 20.38 | $ 27.87 |
Number of Options, Granted (in Shares) | 2,076,800 | 382,000 | |
Weighted Average Exercise Price, Granted | $ 19.27 | $ 24.36 | |
Number of Options, Exercised (in Shares) | (8,325) | (28,672) | (449,093) |
Weighted Average Exercise Price, Exercised | $ 16.47 | $ 16.93 | $ 18.49 |
Number of Options, Forfeited (in Shares) | (325,339) | (127,608) | (608,503) |
Weighted Average Exercise Price, Forfeited | $ 19.14 | $ 20.29 | $ 51.68 |
Number of Options, Outstanding at end of year (in Shares) | 3,247,814 | 1,504,678 | 1,660,958 |
Weighted Average Exercise Price, Outstanding at end of year | $ 19.91 | $ 20.65 | $ 20.38 |
Number of Options, Exercisable at end of year (in Shares) | 1,049,329 | 1,067,363 | 799,640 |
Weighted Average Exercise Price, Exercisable at end of year | $ 20.38 | $ 19.78 | $ 18.97 |
The weighted average remaining contractual life for the share options | $ 4.67 | $ 3.33 | $ 4.18 |
Share-Based Payment (Details)_3
Share-Based Payment (Details) - Schedule of number of RSs and modification in employee RSs - Number of RSs [Member] - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-Based Payment (Details) - Schedule of number of RSs and modification in employee RSs [Line Items] | |||
Outstanding at beginning of year | 49,561 | 104,519 | 145,896 |
Granted | 30,000 | ||
End of restriction period | (31,608) | (52,538) | (58,328) |
Forfeited | (3,248) | (2,420) | (13,049) |
Outstanding at end of year | 14,105 | 49,561 | 104,519 |
The weighted average remaining contractual life for the restricted share | 11 months 15 days | 3 years 4 months 24 days | 4 years 4 months 20 days |
Share-Based Payment (Details)_4
Share-Based Payment (Details) - Schedule of inputs to binomial model used for fair value measurement - $ / shares | 12 Months Ended | ||||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |||
Israeli [Member] | |||||
Share-Based Payment (Details) - Schedule of inputs to binomial model used for fair value measurement [Line Items] | |||||
Dividend yield (%) | [1] | ||||
Expected volatility of the share prices (%) | [1] | ||||
Risk-free interest rate (%) | [1] | ||||
Contractual term of up to (years) | 6 years 6 months | [1] | 6 years 6 months | ||
Exercise multiple (in Dollars per share) | $ 2 | [1] | $ 2 | ||
Weighted average share prices (NIS) (in Dollars per share) | [1] | ||||
Expected average forfeiture rate (%) | [1] | ||||
United States [Member] | |||||
Share-Based Payment (Details) - Schedule of inputs to binomial model used for fair value measurement [Line Items] | |||||
Dividend yield (%) | |||||
Expected volatility of the share prices (%) | |||||
Risk-free interest rate (%) | |||||
Contractual term of up to (years) | 6 years 6 months | ||||
Exercise multiple (in Dollars per share) | |||||
Weighted average share prices (NIS) (in Dollars per share) | |||||
Expected average forfeiture rate (%) | |||||
Bottom of range [member] | Israeli [Member] | |||||
Share-Based Payment (Details) - Schedule of inputs to binomial model used for fair value measurement [Line Items] | |||||
Dividend yield (%) | [1] | ||||
Expected volatility of the share prices (%) | 23% | [1] | 30% | ||
Risk-free interest rate (%) | 0.40% | [1] | 0.01% | ||
Exercise multiple (in Dollars per share) | [1] | ||||
Weighted average share prices (NIS) (in Dollars per share) | $ 13.6 | [1] | $ 20.28 | ||
Expected average forfeiture rate (%) | 0% | [1] | 1.90% | ||
Bottom of range [member] | United States [Member] | |||||
Share-Based Payment (Details) - Schedule of inputs to binomial model used for fair value measurement [Line Items] | |||||
Expected volatility of the share prices (%) | 27% | ||||
Risk-free interest rate (%) | 0.91% | ||||
Weighted average share prices (NIS) (in Dollars per share) | $ 4.8 | ||||
Expected average forfeiture rate (%) | 1.90% | ||||
Top of range [member] | Israeli [Member] | |||||
Share-Based Payment (Details) - Schedule of inputs to binomial model used for fair value measurement [Line Items] | |||||
Dividend yield (%) | [1] | ||||
Expected volatility of the share prices (%) | 40% | [1] | 55% | ||
Risk-free interest rate (%) | 3.55% | [1] | 0.58% | ||
Exercise multiple (in Dollars per share) | [1] | ||||
Weighted average share prices (NIS) (in Dollars per share) | $ 18.41 | [1] | $ 28.98 | ||
Expected average forfeiture rate (%) | 8.50% | [1] | 5.90% | ||
Top of range [member] | United States [Member] | |||||
Share-Based Payment (Details) - Schedule of inputs to binomial model used for fair value measurement [Line Items] | |||||
Dividend yield (%) | [1] | ||||
Expected volatility of the share prices (%) | 47% | ||||
Risk-free interest rate (%) | 3.54% | ||||
Weighted average share prices (NIS) (in Dollars per share) | $ 5.37 | ||||
Expected average forfeiture rate (%) | 8.50% | ||||
[1] During the year ended December 31, 2022, no grants of options or RS were made |
Taxes on Income (Details)
Taxes on Income (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
Aug. 05, 2013 | Dec. 22, 2017 | Dec. 31, 2016 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2014 | |
Taxes on Income (Details) [Line Items] | ||||||
Tax rate | 4% | |||||
Sales Tax percentage | 75% | |||||
Revenue percentage | 25% | |||||
Deferred tax asset when utilisation is dependent on future taxable profits in excess of profits from reversal of taxable temporary differences and entity has suffered loss in jurisdiction to which deferred tax asset relates (in Dollars) | $ 14,000 | |||||
Amendment encouragement law description | Amendment 73 to the Encouragement Law also prescribes special tax tracks for technological enterprises, which became effective in 2017, as follows: Preferred technological enterprise, which is defined in the Encouragement Law as a company that owns the enterprise and is a member of a group whose total consolidated revenues are less than NIS 10 billion in the tax year, will be subject to tax at a rate of 12% on profits deriving from intellectual property (in development area A - a tax rate of 7.5%).Special preferred technological enterprise which is a member of a group whose total consolidated revenues exceed NIS 10 billion in the tax year will be subject to tax at a rate of 6% on preferred income from the enterprise, regardless of the enterprise’s geographical location. Any dividends distributed to “foreign companies”, as defined in the Encouragement Law, deriving from income from the technological enterprises will be subject to tax at a rate of 4%, subject to the conditions prescribed in Section 51Z to the Encouragement Law. | |||||
Rate of tax | 12% | |||||
Carry forward losses (in Dollars) | $ 26,525 | |||||
Law for the Encouragement of Industry (Taxes), 1969 [Member] | ||||||
Taxes on Income (Details) [Line Items] | ||||||
Percentage of income that is generated from industrial enterprise | 90% | |||||
Period of right to deduct expenses related to public offerings | three | |||||
Law for the Encouragement of Capital Investments, 1959 [Member] | ||||||
Taxes on Income (Details) [Line Items] | ||||||
Reduced corporate tax | 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. | |||||
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. | |||||
Tax benefits under Amendment 60 [Member] | ||||||
Taxes on Income (Details) [Line Items] | ||||||
Tax rate | 15% | |||||
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 | 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 [Member] | ||||||
Taxes on Income (Details) [Line Items] | ||||||
Tax rate | 16% | 16% | 25% | 20% | ||
Rate of tax | 7.50% | |||||
2011 Amendment [Member] | ||||||
Taxes on Income (Details) [Line Items] | ||||||
Tax rate | 12.50% | |||||
Preferred technology enterprise [Member] | ||||||
Taxes on Income (Details) [Line Items] | ||||||
Tax rate | 12% | |||||
Special preferred technology enterprise [Member] | ||||||
Taxes on Income (Details) [Line Items] | ||||||
Tax rate | 6% | 6% | ||||
Dividends distributed from technology enterprise earnings [Member] | ||||||
Taxes on Income (Details) [Line Items] | ||||||
Tax rate | 4% | |||||
Legislative Amendments [Member] | ||||||
Taxes on Income (Details) [Line Items] | ||||||
Corporate income tax rate | 23% | |||||
Development Zone A [Member] | Law for the Encouragement of Capital Investments, 1959 [Member] | ||||||
Taxes on Income (Details) [Line Items] | ||||||
Tax rate | 24% | |||||
Development Zone A [Member] | Preferred Enterprise [Member] | ||||||
Taxes on Income (Details) [Line Items] | ||||||
Tax rate | 9% | |||||
Development Zone A [Member] | 2011 Amendment [Member] | ||||||
Taxes on Income (Details) [Line Items] | ||||||
Tax rate | 7% | |||||
Development Zone A [Member] | Preferred technology enterprise [Member] | ||||||
Taxes on Income (Details) [Line Items] | ||||||
Tax rate | 7.50% | |||||
Development Zone B [Member] | Law for the Encouragement of Capital Investments, 1959 [Member] | ||||||
Taxes on Income (Details) [Line Items] | ||||||
Tax rate | 10% | |||||
Alternative Track [Member] | Law for the Encouragement of Capital Investments, 1959 [Member] | ||||||
Taxes on Income (Details) [Line Items] | ||||||
Reduced corporate tax | 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. | |||||
Patents, know-how and certain other intangible [Member] | Law for the Encouragement of Industry (Taxes), 1969 [Member] | ||||||
Taxes on Income (Details) [Line Items] | ||||||
Useful life of intangible assets | eight | |||||
Bottom of range [member] | ||||||
Taxes on Income (Details) [Line Items] | ||||||
Corporate income tax rate | 21% | |||||
Bottom of range [member] | Development Zone A [Member] | Preferred Enterprise [Member] | ||||||
Taxes on Income (Details) [Line Items] | ||||||
Tax rate | 7.50% | |||||
Top of range [member] | ||||||
Taxes on Income (Details) [Line Items] | ||||||
Corporate income tax rate | 35% | |||||
Top of range [member] | Development Zone A [Member] | Preferred Enterprise [Member] | ||||||
Taxes on Income (Details) [Line Items] | ||||||
Tax rate | 9% |
Taxes on Income (Details) - Sch
Taxes on Income (Details) - Schedule of weighted combination of applicable rates | 12 Months Ended |
Dec. 31, 2022 | |
Percent of Foreign Ownership One [Member] | |
Taxes on Income (Details) - Schedule of weighted combination of applicable rates [Line Items] | |
Rate of Reduced Tax | 25% |
Percent of Foreign Ownership Two [Member] | |
Taxes on Income (Details) - Schedule of weighted combination of applicable rates [Line Items] | |
Rate of Reduced Tax | 25% |
Percent of Foreign Ownership Three [Member] | |
Taxes on Income (Details) - Schedule of weighted combination of applicable rates [Line Items] | |
Rate of Reduced Tax | 20% |
Percent of Foreign Ownership Four [Member] | |
Taxes on Income (Details) - Schedule of weighted combination of applicable rates [Line Items] | |
Rate of Reduced Tax | 15% |
Percent of Foreign Ownership Five [Member] | |
Taxes on Income (Details) - Schedule of weighted combination of applicable rates [Line Items] | |
Rate of Reduced Tax | 10% |
Bottom of range [member] | Percent of Foreign Ownership One [Member] | |
Taxes on Income (Details) - Schedule of weighted combination of applicable rates [Line Items] | |
Tax Exemption Period | 2% |
Reduced Tax Period | 5% |
Percent of Foreign Ownership | 0% |
Bottom of range [member] | Percent of Foreign Ownership Two [Member] | |
Taxes on Income (Details) - Schedule of weighted combination of applicable rates [Line Items] | |
Tax Exemption Period | 2% |
Reduced Tax Period | 8% |
Percent of Foreign Ownership | 25% |
Bottom of range [member] | Percent of Foreign Ownership Three [Member] | |
Taxes on Income (Details) - Schedule of weighted combination of applicable rates [Line Items] | |
Tax Exemption Period | 2% |
Reduced Tax Period | 8% |
Percent of Foreign Ownership | 49% |
Bottom of range [member] | Percent of Foreign Ownership Four [Member] | |
Taxes on Income (Details) - Schedule of weighted combination of applicable rates [Line Items] | |
Tax Exemption Period | 2% |
Reduced Tax Period | 8% |
Percent of Foreign Ownership | 74% |
Bottom of range [member] | Percent of Foreign Ownership Five [Member] | |
Taxes on Income (Details) - Schedule of weighted combination of applicable rates [Line Items] | |
Tax Exemption Period | 2% |
Reduced Tax Period | 8% |
Percent of Foreign Ownership | 90% |
Top of range [member] | Percent of Foreign Ownership One [Member] | |
Taxes on Income (Details) - Schedule of weighted combination of applicable rates [Line Items] | |
Tax Exemption Period | 10% |
Reduced Tax Period | 0% |
Percent of Foreign Ownership | 25% |
Top of range [member] | Percent of Foreign Ownership Two [Member] | |
Taxes on Income (Details) - Schedule of weighted combination of applicable rates [Line Items] | |
Tax Exemption Period | 10% |
Reduced Tax Period | 0% |
Percent of Foreign Ownership | 49% |
Top of range [member] | Percent of Foreign Ownership Three [Member] | |
Taxes on Income (Details) - Schedule of weighted combination of applicable rates [Line Items] | |
Tax Exemption Period | 10% |
Reduced Tax Period | 0% |
Percent of Foreign Ownership | 74% |
Top of range [member] | Percent of Foreign Ownership Four [Member] | |
Taxes on Income (Details) - Schedule of weighted combination of applicable rates [Line Items] | |
Tax Exemption Period | 10% |
Reduced Tax Period | 0% |
Percent of Foreign Ownership | 90% |
Top of range [member] | Percent of Foreign Ownership Five [Member] | |
Taxes on Income (Details) - Schedule of weighted combination of applicable rates [Line Items] | |
Tax Exemption Period | 10% |
Reduced Tax Period | 0% |
Percent of Foreign Ownership | 100% |
Taxes on Income (Details) - S_2
Taxes on Income (Details) - Schedule of deferred tax liabilities and assets - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Schedule Of Deferred Tax Liabilities And Assets Abstract | ||
Carryforward tax losses | ||
Carryforward tax losses | (1,330) | |
Employee benefits | ||
Deferred tax income (expenses) | (1,330) | |
Deferred tax assets, net |
Taxes on Income (Details) - S_3
Taxes on Income (Details) - Schedule of current taxes on income - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of current taxes on income [Abstract] | |||
Current taxes | $ 62 | $ 345 | $ 95 |
Deferred tax expenses (income) | 1,330 | ||
Taxes in respect of prior years | |||
Taxes on income | $ 62 | $ 345 | $ 1,425 |
Taxes on Income (Details) - S_4
Taxes on Income (Details) - Schedule of reconciliation of taxes on profit loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule Of Reconciliation Of Taxes On Profit Loss Abstract | |||
Gain before taxes on income | $ 18,565 | ||
Statutory tax rate | 23% | ||
Tax calculated using the statutory tax rate | $ 4,270 | ||
Taxable income with preferred income tax rates by virtue of the Encouragement Law | (3,082) | ||
Tax exempt income, income subject to special tax rates and nondeductible expenses and other | (303) | ||
Difference between measurement basis of income/expenses for tax purposes and measurement basis of income/expenses for financial reporting purposes | 441 | ||
Increase in unrecognized tax losses in the year | |||
Prior year taxes | |||
Other | 99 | ||
Tax on income | $ 1,425 | ||
Effective tax rate | 7.70% |
Supplementary Information to _3
Supplementary Information to the Statements of Profit and Loss (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Supplementary Information to the Statements of Profit and Loss (Details) [Line Items] | |||
Business combination. | $ 24,282 | ||
Cost of sales [Member] | |||
Supplementary Information to the Statements of Profit and Loss (Details) [Line Items] | |||
Amortization of intangible assets | $ 5,376 | 574 | $ 0 |
Selling, general and administrative expense [Member] | |||
Supplementary Information to the Statements of Profit and Loss (Details) [Line Items] | |||
Amortization of intangible assets | $ 1,807 | $ 265 | $ 0 |
Supplementary Information to _4
Supplementary Information to the Statements of Profit and Loss (Details) - Schedule of additional information about revenues - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | ||
Supplementary Information to the Statements of Profit and Loss (Details) - Schedule of additional information about revenues [Line Items] | ||||
Revenues from major customers | $ 42,655 | $ 56,240 | $ 97,164 | |
Customer A [Member] | ||||
Supplementary Information to the Statements of Profit and Loss (Details) - Schedule of additional information about revenues [Line Items] | ||||
Revenues from major customers | 16,195 | 11,947 | 18,290 | |
Customer B [Member] | ||||
Supplementary Information to the Statements of Profit and Loss (Details) - Schedule of additional information about revenues [Line Items] | ||||
Revenues from major customers | [1] | 14,205 | 31,936 | 65,081 |
Customer C [Member] | ||||
Supplementary Information to the Statements of Profit and Loss (Details) - Schedule of additional information about revenues [Line Items] | ||||
Revenues from major customers | [2] | $ 12,255 | $ 12,357 | $ 13,793 |
[1]Revenue is attributed to the Proprietary segment.[2] Revenue is attributed mainly to the Distribution segment. |
Supplementary Information to _5
Supplementary Information to the Statements of Profit and Loss (Details) - Schedule of revenues based on location of customers - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Supplementary Information to the Statements of Profit and Loss (Details) - Schedule of revenues based on location of customers [Line Items] | |||
Total Revenue | $ 129,338 | $ 103,642 | $ 133,246 |
U.S.A and North America [Member] | |||
Supplementary Information to the Statements of Profit and Loss (Details) - Schedule of revenues based on location of customers [Line Items] | |||
Total Revenue | 75,851 | 49,763 | 84,949 |
Israel [Member] | |||
Supplementary Information to the Statements of Profit and Loss (Details) - Schedule of revenues based on location of customers [Line Items] | |||
Total Revenue | 32,031 | 35,774 | 36,144 |
Europe [Member] | |||
Supplementary Information to the Statements of Profit and Loss (Details) - Schedule of revenues based on location of customers [Line Items] | |||
Total Revenue | 5,277 | 5,677 | 4,461 |
Latin America [Member] | |||
Supplementary Information to the Statements of Profit and Loss (Details) - Schedule of revenues based on location of customers [Line Items] | |||
Total Revenue | 11,293 | 9,127 | 6,867 |
Asia [Member] | |||
Supplementary Information to the Statements of Profit and Loss (Details) - Schedule of revenues based on location of customers [Line Items] | |||
Total Revenue | 4,581 | 3,167 | 766 |
Others [Member] | |||
Supplementary Information to the Statements of Profit and Loss (Details) - Schedule of revenues based on location of customers [Line Items] | |||
Total Revenue | $ 305 | $ 134 | $ 59 |
Supplementary Information to _6
Supplementary Information to the Statements of Profit and Loss (Details) - Schedule of income and expenses - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | ||
Cost of goods sold [Member] | ||||
Supplementary Information to the Statements of Profit and Loss (Details) - Schedule of income and expenses [Line Items] | ||||
Cost of materials | [1] | $ 53,666 | $ 63,945 | $ 54,745 |
Salary and related expenses | [2] | 14,967 | 17,486 | 17,957 |
Subcontractors | 4,673 | 4,892 | 4,876 | |
Depreciation and amortization | [3] | 8,553 | 3,627 | 3,248 |
Energy | 1,365 | 1,464 | 1,626 | |
Other manufacturing expenses | 1,785 | 1,298 | 575 | |
Total expenses | 85,009 | 92,712 | 83,027 | |
Decrease (increase) in inventories | (2,373) | (19,398) | 2,667 | |
Total Cost of goods sold | 82,636 | 73,314 | 85,694 | |
Research and development [Member] | ||||
Supplementary Information to the Statements of Profit and Loss (Details) - Schedule of income and expenses [Line Items] | ||||
Salary and related expenses | 5,608 | 5,076 | 6,045 | |
Subcontractors | 4,216 | 3,656 | 4,794 | |
Materials and allocation of facility costs | 2,538 | 1,896 | 1,682 | |
Depreciation and amortization | 574 | 616 | 725 | |
Others | 236 | 113 | 363 | |
Total Research and development | 13,172 | 11,357 | 13,609 | |
Selling and marketing [Member] | ||||
Supplementary Information to the Statements of Profit and Loss (Details) - Schedule of income and expenses [Line Items] | ||||
Salary and related expenses | 4,047 | 1,930 | 1,639 | |
Marketing support | 668 | 136 | 144 | |
Packing, shipping and delivery | 1,484 | 912 | 750 | |
Marketing and advertising | 2,812 | 1,193 | 586 | |
Registration and marketing fees | 3,463 | 1,262 | 934 | |
Depreciation and amortization | [4] | 2,056 | 488 | 147 |
Others | 754 | 357 | 318 | |
Total Selling and marketing | 15,284 | 6,278 | 4,518 | |
General and administrative [Member] | ||||
Supplementary Information to the Statements of Profit and Loss (Details) - Schedule of income and expenses [Line Items] | ||||
Salary and related expenses | 4,455 | 3,853 | 3,870 | |
Employees welfare | 1,299 | 1,259 | 978 | |
Professional fees and public company expense | 4,213 | 5,055 | 3,135 | |
Depreciation, amortization and impairment | 973 | 875 | 779 | |
Communication and software services | 905 | 977 | 924 | |
Others | 958 | 617 | 453 | |
Total General and administrative | 12,803 | 12,636 | 10,139 | |
Financial (expense)income [Member] | ||||
Financial income | ||||
Interest income and gains from marketable securities | 91 | 295 | 1,027 | |
Financial expense | ||||
Revaluation of long term liabilities | (6,266) | (994) | ||
Fees and interest paid to financial institutions | (914) | (283) | (266) | |
Derivatives instruments measured at fair value | 548 | (565) | (1,097) | |
Translation differences of financial assets and liabilities | (250) | 358 | (438) | |
Bond securities measured at fair value | 102 | |||
Total Financial (expense) income | $ (6,791) | $ (1,189) | $ (672) | |
[1] Costs of materials for the year ended December 31, 2021, includes $24,282 of inventory obtained in connection with the business combination. Refer to Note 5b for further detail on the business combination. Reduction of salary and related expenses was attributable to the 2022 labor strike. |
Income (Loss) Per Share (Detail
Income (Loss) Per Share (Details) - Schedule of details of number of shares and income (loss) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of Details of Number of Shares And Income Loss [Abstract] | |||
Weighted Number of Shares For the computation of basic income (loss) | 44,815,248 | 44,771,766 | 44,140,771 |
Income Attributed to equity holders of the Company For the computation of basic income (loss) | $ (2,321) | $ (2,230) | $ 17,140 |
Weighted Number of Shares Effect of potential dilutive ordinary shares | 41,328 | 130,177 | 449,107 |
Income Attributed to equity holders of the Company Effect of potential dilutive ordinary shares | |||
Weighted Number of Shares For the computation of diluted income (loss) | 44,856,576 | 44,901,943 | 44,589,878 |
Loss Attributed to equity holders of the Company For the computation of diluted income (loss) | $ (2,321) | $ (2,230) | $ 17,140 |
Operating Segments (Details) -
Operating Segments (Details) - Schedule of reporting on operating segments - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Operating Segments (Details) - Schedule of reporting on operating segments [Line Items] | |||
Revenues | $ 129,339 | $ 103,642 | $ 133,246 |
Gross profit | 46,703 | 30,328 | 47,552 |
Unallocated corporate expenses | (42,171) | (31,024) | (28,315) |
Finance income, net | (6,791) | (1,189) | (672) |
Income before taxes on income | (2,259) | (1,885) | 18,565 |
Proprietary Products [Member] | |||
Operating Segments (Details) - Schedule of reporting on operating segments [Line Items] | |||
Revenues | 102,598 | 75,521 | 100,916 |
Gross profit | 44,369 | 27,327 | 43,166 |
Distribution [Member] | |||
Operating Segments (Details) - Schedule of reporting on operating segments [Line Items] | |||
Revenues | 26,741 | 28,121 | 32,330 |
Gross profit | $ 2,334 | $ 3,001 | $ 4,386 |
Balances and Transactions wit_3
Balances and Transactions with Related Parties (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Mar. 20, 2020 | Feb. 10, 2020 | Nov. 21, 2019 | Dec. 31, 2022 | Jul. 04, 2022 | |
Balances and Transactions with Related Parties (Details) [Line Items] | |||||
Funding | $ 30,000 | ||||
Employment terms, description | the Company’s shareholders approved an amendment to the employment terms of the Company’s CEO, pursuant to which the monthly gross salary was increased to NIS 88,000 (or $25,462), effective as July 1, 2019. On October 12, 2021, the Company’s Board of Directors approved an amendment to the employment terms of the Company’s CEO, pursuant to which the CEO’s monthly gross salary increased to NIS 92,400 (or $28,607), effective as of July 1, 2021. On November 21, 2022, the Company’s Board of Directors approved an amendment to the employment terms of the Company’s CEO, pursuant to which the CEO’s monthly gross salary increased to NIS 96,000 (or $28,575), effective as of July 1, 2022. | ||||
FIMI Funds [Member] | |||||
Balances and Transactions with Related Parties (Details) [Line Items] | |||||
Shares purchased (in Shares) | 4,166,667 | 5,240,956 | |||
Share price (in Dollars per share) | $ 6 | $ 6 | |||
Interest rate, percentage | 13% | ||||
FIMI Funds [Member] | Non-adjusting events after reporting period [Member] | |||||
Balances and Transactions with Related Parties (Details) [Line Items] | |||||
Gross proceeds | $ 25,000,000 | ||||
Funds ownership percentage | 21% | ||||
Chief Executive Officer [Member] | |||||
Balances and Transactions with Related Parties (Details) [Line Items] | |||||
Annual bonus | $ 175,000 |
Balances and Transactions wit_4
Balances and Transactions with Related Parties (Details) - Schedule of balances with related parties - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Schedule of Balances with Related Parties [Abstract] | ||
Trade receivable | $ 544 | $ 1,295 |
Other accounts payables | $ 186 | $ 101 |
Balances and Transactions wit_5
Balances and Transactions with Related Parties (Details) - Schedule of transactions with employed/directors that accounts as related parties | 12 Months Ended | ||
Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
Schedule of Transactions with Employed Directors that Accounts as Related Parties [Abstract] | |||
Remuneration of directors not employed by the Company or on its behalf (in Dollars) | $ 331 | $ 487 | $ 506 |
Directors not employed by the Company | 9 | 9 | 9 |
Total Directors employed and not employed by the Company | 9 | 9 | 9 |
Balances and Transactions wit_6
Balances and Transactions with Related Parties (Details) - Schedule of transactions with key executive personnel - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of Transactions with Key Executive Personnel [Abstract] | |||
Salary and Related Expenses | $ 3,590 | $ 2,791 | $ 3,237 |
Share-based payment | 547 | 255 | 457 |
Total | $ 4,137 | $ 3,046 | $ 3,694 |
Balances and Transactions wit_7
Balances and Transactions with Related Parties (Details) - Schedule of transactions with related parties - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of Transactions with Related Parties [Abstract] | |||
Revenues | $ 5,298 | $ 5,356 | $ 3,899 |
Cost of Goods Sold | 19 | 51 | 255 |
Selling and marketing expenses | 0 | 0 | 0 |
General and administrative expenses | $ 214 | $ 227 | $ 522 |