Document and Entity Information
Document and Entity Information | 12 Months Ended |
Dec. 31, 2021shares | |
Document Information [Line Items] | |
Document Type | 20-F |
Document Registration Statement | false |
Document Annual Report | true |
Document Period End Date | Dec. 31, 2021 |
Document Transition Report | false |
Document Shell Company Report | false |
Entity File Number | 001-35773 |
Entity Registrant Name | RedHill Biopharma Ltd. |
Entity Incorporation, State or Country Code | L3 |
Entity Address, Address Line One | 21 Ha’arba’a Street |
Entity Address, City or Town | Tel Aviv |
Entity Address, Postal Zip Code | 6473921 |
Entity Address, Country | IL |
Entity Common Stock, Shares Outstanding | 526,842,294 |
Entity Well-known Seasoned Issuer | No |
Entity Voluntary Filers | No |
Entity Current Reporting Status | Yes |
Entity Interactive Data Current | Yes |
Entity Filer Category | Accelerated Filer |
Entity Emerging Growth Company | false |
ICFR Auditor Attestation Flag | true |
Document Accounting Standard | International Financial Reporting Standards |
Entity Shell Company | false |
Entity Central Index Key | 0001553846 |
Current Fiscal Year End Date | --12-31 |
Document Fiscal Year Focus | 2021 |
Document Fiscal Period Focus | FY |
Amendment Flag | false |
Auditor Name | Kesselman & Kesselman |
Auditor Location | Tel-Aviv, Israel |
Auditor Firm ID | 1309 |
American Depositary Shares, each representing ten Ordinary Shares | |
Document Information [Line Items] | |
Title of 12(b) Security | American Depositary Shares, each representing ten Ordinary Shares (1) |
Trading Symbol | RDHL |
Security Exchange Name | NASDAQ |
Ordinary shares | |
Document Information [Line Items] | |
Title of 12(b) Security | Ordinary Shares, par value NIS 0.01 per share (2) |
Trading Symbol | RDHL |
Security Exchange Name | NASDAQ |
Business contact | |
Document Information [Line Items] | |
Entity Address, Address Line One | 21 Ha’arba’a Street |
Entity Address, City or Town | Tel Aviv |
Entity Address, Postal Zip Code | 6473921 |
Entity Address, Country | IL |
City Area Code | 972 |
Local Phone Number | 3-541-3131 |
Contact Personnel Name | Micha Ben Chorin |
Contact Personnel Fax Number | 972-3-541-3144 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | |||
NET REVENUES | $ 85,757 | $ 64,359 | $ 6,291 |
COST OF REVENUES | 49,406 | 36,892 | 2,259 |
GROSS PROFIT | 36,351 | 27,467 | 4,032 |
RESEARCH AND DEVELOPMENT EXPENSES | 29,498 | 16,491 | 17,419 |
SELLING AND MARKETING EXPENSES | 55,623 | 49,285 | 18,333 |
GENERAL AND ADMINISTRATIVE EXPENSES | 32,365 | 25,375 | 11,481 |
OPERATING LOSS | 81,135 | 63,684 | 43,201 |
FINANCIAL INCOME | 51 | 270 | 1,335 |
FINANCIAL EXPENSES | 16,660 | 12,759 | 438 |
FINANCIAL EXPENSES (INCOME), net | 16,609 | 12,489 | (897) |
LOSS AND COMPREHENSIVE LOSS FOR THE PERIOD | $ 97,744 | $ 76,173 | $ 42,304 |
LOSS PER ORDINARY SHARE, basic (U.S. dollars) | $ 0.21 | $ 0.21 | $ 0.14 |
LOSS PER ORDINARY SHARE, diluted (U.S. dollars) | $ 0.21 | $ 0.21 | $ 0.14 |
WEIGHTED AVERAGE OF ORDINARY SHARES (in thousands) | 465,273 | 364,276 | 296,922 |
CONSOLIDATED STATEMENTS OF FINA
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 29,474 | $ 29,295 |
Bank deposits | 8,530 | 17 |
Financial assets at fair value through profit or loss | 481 | |
Trade receivables | 31,677 | 28,655 |
Prepaid expenses and other receivables | 4,661 | 5,521 |
Inventory | 14,810 | 6,526 |
Total current assets | 89,152 | 70,495 |
NON-CURRENT ASSETS: | ||
Restricted cash | 16,169 | 16,164 |
Fixed assets | 572 | 511 |
Right-of-use assets | 3,651 | 5,192 |
Intangible assets | 71,644 | 87,879 |
Total non-current assets | 92,036 | 109,746 |
TOTAL ASSETS | 181,188 | 180,241 |
CURRENT LIABILITIES: | ||
Accounts payable | 11,664 | 11,553 |
Lease liabilities | 1,618 | 1,710 |
Allowance for deductions from revenue | 30,711 | 18,343 |
Accrued expenses and other current liabilities | 20,896 | 24,082 |
Payable in respect of intangible asset purchase | 16,581 | 17,547 |
Total current liabilities | 81,470 | 73,235 |
NON-CURRENT LIABILITIES: | ||
Borrowing | 83,620 | 81,386 |
Payable in respect of intangible assets purchase | 3,899 | 7,199 |
Lease liabilities | 2,574 | 3,807 |
Royalty obligation | 750 | 750 |
Total non-current liabilities | 90,843 | 93,142 |
TOTAL LIABILITIES | 172,313 | 166,377 |
EQUITY: | ||
Ordinary shares | 1,495 | 1,054 |
Additional paid-in capital | 375,246 | 293,144 |
Accumulated deficit | (367,866) | (280,334) |
TOTAL EQUITY | 8,875 | 13,864 |
TOTAL LIABILITIES AND EQUITY | $ 181,188 | $ 180,241 |
CONSOLIDATED STATEMENTS OF CHAN
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY - USD ($) $ in Thousands | Ordinary share | Additional paid-in capital | Accumulated deficit | Total |
Balance at beginning of period at Dec. 31, 2018 | $ 767 | $ 219,505 | $ (169,086) | $ 51,186 |
Share-based compensation to employees and service providers | 3,027 | 3,027 | ||
Issuance of ordinary shares, net of expenses | 195 | 47,893 | 48,088 | |
Exercise of options into ordinary shares | 5 | 5 | ||
Comprehensive loss | (42,304) | (42,304) | ||
Balance at end of period at Dec. 31, 2019 | 962 | 267,403 | (208,363) | 60,002 |
Share-based compensation to employees and service providers | 4,202 | 4,202 | ||
Issuance of ordinary shares, net of expenses | 84 | 23,783 | 23,867 | |
Exercise of options into ordinary shares | 52 | 52 | ||
Share-based compensation in consideration for intangible assets | 8 | 1,906 | 1,914 | |
Comprehensive loss | (76,173) | (76,173) | ||
Balance at end of period at Dec. 31, 2020 | 1,054 | 293,144 | (280,334) | 13,864 |
Share-based compensation to employees and service providers | 10,212 | 10,212 | ||
Issuance of ordinary shares, net of expenses | 424 | 78,113 | 78,537 | |
Exercise of options into ordinary shares | 17 | 3,989 | 4,006 | |
Comprehensive loss | (97,744) | (97,744) | ||
Balance at end of period at Dec. 31, 2021 | $ 1,495 | $ 375,246 | $ (367,866) | $ 8,875 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
OPERATING ACTIVITIES: | |||
Comprehensive loss | $ (97,744) | $ (76,173) | $ (42,304) |
Adjustments in respect of income and expenses not involving cash flow: | |||
Share-based compensation to employees and service providers | 10,212 | 4,202 | 3,027 |
Depreciation | 1,914 | 1,710 | 997 |
Amortization and impairment of intangible assets | 16,235 | 7,035 | 216 |
Non-cash interest expenses related to borrowing and payable in respect of intangible assets purchase | 5,366 | 6,032 | |
Fair value adjustments on derivative financial instruments | (344) | ||
Fair value (gains) losses on financial assets at fair value through profit or loss | 5 | 94 | (27) |
Exchange differences and revaluation of bank deposits | 118 | 101 | 24 |
Total adjustments in respect of income and expenses not involving cash flow | 33,850 | 19,174 | 3,893 |
Changes in assets and liability items: | |||
Increase in trade receivables | (3,021) | (27,439) | (258) |
Decrease (increase) in prepaid expenses and other receivables | 860 | (3,277) | (368) |
Increase in inventories | (8,285) | (4,644) | (1,113) |
Increase in accounts payable | 111 | 7,369 | 860 |
Increase (decrease) in accrued expenses and other liabilities | (3,186) | 19,335 | (2,726) |
Increase in allowance for deductions from revenue | 12,368 | 17,076 | 1,267 |
Total changes in assets and liability items | (1,153) | 8,420 | (2,338) |
Net cash used in operating activities | (65,047) | (48,579) | (40,749) |
INVESTING ACTIVITIES: | |||
Purchase of fixed assets | (115) | (406) | (168) |
Purchase of intangible assets | (53,368) | (35) | |
Change in investment in current bank deposits | (8,500) | 10,200 | (2,069) |
Purchase of financial assets at fair value through profit or loss | (4,325) | ||
Proceeds from sale of financial assets at fair value through profit or loss | 475 | 7,925 | 11,761 |
Net cash provided by (used in) investing activities | (8,140) | (35,649) | 5,164 |
FINANCING ACTIVITIES: | |||
Proceeds from long-term borrowing, net of transaction costs | 78,061 | ||
Proceeds from issuance of ordinary shares, net of issuance costs | 78,536 | 23,867 | 36,300 |
Exercise of options into ordinary shares | 4,006 | 52 | 5 |
Repayment of payable in respect of intangible asset purchase | (7,397) | ||
Increase in restricted cash | (20,000) | ||
Decrease in restricted cash | 4,000 | ||
Payment of principal with respect to lease liabilities | (1,683) | (1,610) | (796) |
Net cash provided by financing activities | 73,462 | 84,370 | 35,509 |
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 275 | 142 | (76) |
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS | (96) | 130 | 94 |
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 29,295 | 29,023 | 29,005 |
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD | 29,474 | 29,295 | 29,023 |
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH | 47 | 414 | 753 |
SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH | 11,280 | 6,654 | 251 |
Acquisition of right-of-use assets by means of lease liabilities | $ 303 | 2,930 | 2,805 |
Purchase of intangible assets posted as payable | 24,619 | ||
Purchase of an intangible asset in consideration for issuance of shares | $ 1,914 | $ 11,788 |
GENERAL
GENERAL | 12 Months Ended |
Dec. 31, 2021 | |
GENERAL | |
GENERAL | NOTE 1 - GENERAL: a. General: 1) The Company’s ordinary shares were traded on the Tel-Aviv Stock Exchange (“TASE”) from February 2011 to February 2020, after which the Company voluntarily delisted from trading on the TASE, effective February 13, 2020. The Company’s American Depositary Shares (“ADSs”) were traded on the Nasdaq Capital Market from December 27, 2012 and have been listed on the Nasdaq Global Market (“Nasdaq”) since July 20, 2018. The Company’s registered address is 21 Ha’arba’a St, Tel-Aviv, Israel. 2) Since the Company established its commercial presence in the U.S. in 2017, it has promoted or commercialized various GI-related products that were either developed internally or acquired through in-licensing agreements. As of the date of approval of these financial statements, the Company commercializes in the U.S., mainly, Talicia ® , for the treatment of Helicobacter pylori infection in adults , the first product approved by the U .S. Food and Drug Administration (“FDA”) being developed primarily internally by the Company, and Movantik ® , for the treatment of opioid-induced constipation. Effective April 1, 2020, RedHill Inc. entered into an exclusive license agreement (the “License Agreement”) with AstraZeneca AB (“AstraZeneca”), granting RedHill Inc. exclusive, worldwide (excluding Europe, Canada) commercialization and development rights to Movantik ® 3) The Company plans to further fund its future operations through commercialization and out-licensing of its therapeutic candidates, commercialization of in-licensed or acquired products and raising additional capital through equity or debt financing or through non-dilutive financing. The Company’s current cash resources are not sufficient to complete the research and development of all of its therapeutic candidates and to fully support its commercial operations until generation of sustainable positive cash flows. Management expects that the Company will incur additional losses as it continues to focus its resources on advancing the development of its therapeutic candidates, as well as advancing its commercial operations, based on a prioritized plan that will result in negative cash flows from operating activities. The Company believes its existing capital resources should be sufficient to fund its current and planned operations for at least the next 12 months. If the Company is unable to out-license, sell or commercialize its therapeutic candidates, generate sufficient and sustainable revenues from its commercial operations, or obtain future financing, the Company may be forced to delay, reduce the scope of, or eliminate one or more of its research and development or commercialization programs, any of which may have a material adverse effect on the Company’s business, financial condition or results of operations. The current COVID-19 pandemic has presented substantial public health and economic challenges around the world and specifically in the Company’s target markets in the U.S., affecting employees, patients, medical clinics, medical diagnosis, communities and business operations. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted at this stage. The Company took actions designed to mitigate the potential impact of the COVID-19 pandemic on its business operations and to date, the COVID-19 pandemic has not caused significant disruptions to the supply chain and the Company has sufficient supply on hand to meet U.S. commercial demand and clinical studies’ needs. A number of the Company’s commercial activities have been impacted by the COVID-19 pandemic, including some launch sales and marketing activities for Talicia ® H. pylori ® ® Although no major disruptions, other than manageable impact on its development and commercial activities, the Company continues to assess the potential impact of the COVID-19 pandemic on its business and operations, including on its sales, expenses, supply chain, financial resources, and clinical trials. b. Approval of the financial statements: The date of the approval of these financial statements by the Board of Directors (the "BoD") is March 17, 2022. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2021 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES a. Basis for presentation of the financial statements The consolidated financial statements of the Company have been prepared in accordance with International Financial Reporting Standards (“IFRS”), as issued by the International Accounting Standards Board (“IASB”). The significant accounting policies described below have been applied consistently in relation to all the periods presented, unless otherwise stated. The consolidated financial statements have been prepared under the historical cost convention, subject to adjustments in respect of revaluation of financial assets and financial liabilities at fair value through profit or loss. The preparation of financial statements in conformity with IFRS requires the use of certain critical accounting estimates. It also requires management to exercise its judgment in applying the Company’s accounting policies. The areas involving a higher degree of judgment or complexity, or areas where assumptions and estimates are significant to the financial statements, are disclosed in note 3. Actual results could differ significantly from those estimates and assumptions. b. Translation of foreign currency transactions and balances 1) Functional and presentation currency Items included in the consolidated financial statements are measured using the currency of the primary economic environment in which the Company and its subsidiary operate (the “Functional Currency”). The consolidated financial statements are presented in U.S. dollars (“$”), which is the Company’s functional and presentation currency. 2) Transactions and balances Foreign currency transactions in currencies different from the Functional Currency (hereafter foreign currency, mostly New Israeli Shekel (“NIS”) and Euro are translated into the Functional Currency using the exchange rates at the dates of the transactions. Foreign exchange differences resulting from the settlement of such transactions and from the translation of period-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recorded in the Statements of Comprehensive Loss under financial income or financial expenses. c. Principles of consolidation The Company’s consolidated financial statements include the accounts of the Company and its subsidiary. All intercompany balances and transactions have been eliminated in consolidation. d. Cash and cash equivalents Cash and cash equivalents include cash on hand and unrestricted short-term bank deposits with maturities of three months or less. e. Trade receivables Trade receivables are recognized initially at the amount of consideration that is unconditional. They are subsequently measured at amortized cost using the effective interest method, less expected loss allowance. See also note (i)(3). f. Inventory The Company’s inventory represents items purchased by the Company and held for sale in the ordinary course of business, as well as inventory in the process of production for a sale in the ordinary course of business or materials or supplies to be used in the production process, to the extent they are recoverable. The inventory is stated at the lower of cost or net realizable value. Cost of inventory is determined using the first-in, first-out method. The Company continually evaluates inventory for potential loss due to excess quantity or obsolete or slow-moving inventory by comparing sales history and sales projections to the inventory on hand. When evidence indicates that the carrying value of a product may not be recoverable, a charge is recorded to reduce the inventory to its current net realizable value. g. Fixed assets Fixed assets items are stated at cost less accumulated depreciation. Depreciation is computed by the straight-line method, to reduce the cost of fixed assets to their residual value over their estimated useful lives as follows: % Computer equipment 33 Office furniture and equipment 8-15 Leasehold improvements are depreciated by the straight-line method over the shorter of the term of the lease or the estimated useful life of the improvements. h. Intangible assets 1) Licenses The Company’s intangible assets represent in-licenses of development-phase compounds acquired by the Company, where the Company continues or has the option to continue to do the development work (“R&D assets”), as well as commercialization rights Commercialization R&D assets that are available for use are stated at cost and amortized on a straight-line basis over their useful life from the time they are available for use. R&D assets that are not available for use are tested for impairment at least annually. Commercialization In determining the useful life of a commercialization Amounts due for future payment based on contractual agreements are accrued upon reaching the relevant milestones. All intangible assets are tested for impairment if any events have occurred or changes in circumstances have taken place which might indicate that their carrying amounts may not be recoverable. See also note 3 for key assumptions used in the determination of the recoverable amounts. An impairment loss is recognized for the amount by which the asset’s carrying amount exceeds its recoverable amount. The recoverable amount is the higher of an asset’s fair value less costs to sell and value in use. For purposes of assessing impairment, assets are grouped at the lowest levels for which there are separately identifiable cash flows (cash-generating units). 2) Research and development Research expenses are recognized as an expense as incurred. An intangible asset arising from the development of the Company’s therapeutic candidates is recognized if all of the following conditions are met: ● it is technically feasible to complete the intangible asset so that it will be available for use; ● management intends to complete the intangible asset and use it or sell it; ● there is an ability to use or sell the intangible asset; ● it can be demonstrated how the intangible asset will generate probable future economic benefits; and ● adequate technical, financial and other resources to complete the development and to use or sell the intangible asset are available and costs associated with the intangible asset during development can be measured reliably. Other development costs that do not meet the above criteria are recognized as expenses as incurred. Development costs previously recognized as an expense are not recognized as an asset in a subsequent period. Research and development costs for the performance of pre-clinical trials, clinical trials, and manufacturing by subcontractors are recognized as expenses when incurred. i. Financial assets 1) Classification The financial assets of the Company are classified into the following categories: financial assets at fair value through profit or loss, and financial assets at amortized cost. The classification is done on the basis of the Company’s business model for managing the financial asset and the contractual cash flow characteristics of the financial asset. a) Financial assets at amortized cost are assets held within a business model whose objective is to hold assets in order to collect contractual cash flows and the contractual terms of the financial asset give rise on specified dates to cash flows that are solely payments of principal and interest on the principal amount outstanding . Financial assets at amortized cost are included in current assets, except for those with maturities greater than 12 months after the Statements of Financial Position date (for which they are classified as noncurrent assets). Financial assets at amortized cost of the Company are included in trade receivables, and other receivables and bank deposits in the Statements of Financial Position. b) Financial assets at fair value through profit or loss of the Company are assets not measured at amortized cost in accordance with (1)(a) above. Assets in this category are classified as current assets if they are expected to be settled within 12 months; otherwise, they are classified as noncurrent. 2) Regular purchases and sales of financial assets are recognized on the settlement date, which is the date on which the asset is delivered to the Company or delivered by the Company. Investments are initially recognized at fair value plus direct incremental transaction costs for all financial assets not recorded at fair value through profit or loss, except for trade receivables, that are recognized initially at the amount of consideration that is unconditional. Financial assets measured at fair value through profit or loss are initially recognized at fair value, related transaction costs are expensed to profit or loss. Financial assets are derecognized when the rights to receive cash flows from the investments have expired or have been transferred and the Company has transferred substantially all risks and rewards of ownership. Financial assets at fair value through profit or loss are subsequently recorded at fair value. Financial assets at amortized cost are measured in subsequent periods at amortized cost using the effective interest method. Gains or losses arising from changes in the fair value of financial assets at fair value through profit or loss are presented in the Statements of Comprehensive Loss under “Financial Expenses (Income), net.” 3) The Company recognizes a loss allowance for expected credit losses on financial assets at amortized cost. At each reporting date, the Company assesses whether the credit risk on a financial instrument has increased significantly since initial recognition. If the financial instrument is determined to have a low credit risk at the reporting date, the Company assumes that the credit risk on a financial instrument has not increased significantly since initial recognition. The Company measures the loss allowance for expected credit losses on trade receivables that are within the scope of IFRS 15 and on financial instruments for which the credit risk has increased significantly since initial recognition based on lifetime expected credit losses. Otherwise, the Company measures the loss allowance at an amount equal to 12-month expected credit losses at the current reporting date. j. Financial liabilities Financial liabilities are initially recognized at their fair value minus transaction costs that are directly attributable to the issue of the financial liability and are subsequently measured at amortized cost. The Company’s financial liabilities at amortized cost include: accounts payable, accrued expenses and other current liabilities, lease liabilities, borrowing, payable in respect of the intangible asset and royalty obligation. k. Share capital The Company ’ l. Employee benefits 1) Pension and retirement benefit obligations In any matter related to payment of pension and severance pay to employees in Israel to be dismissed or to retire from the Company, the Company operates in accordance with labor laws. Labor laws and agreements in Israel, as well as the Company’s practice, require the Company to pay severance pay and/or pensions to employees dismissed or retired, in certain circumstances. The Company has a severance pay plan in accordance with Section 14 of the Israeli Severance Pay Law which is treated as a defined contribution plan. According to the plan, the Company regularly makes payments to severance pay or pension funds without having a legal or constructive obligation to pay further contributions if the fund does not hold sufficient assets to pay the related payments to employees’ service in current and prior periods. Contributions for severance pay or pension are recognized as employee benefit expenses when they are due commensurate with receipt of work services from the employee, and no further provision is required in the financial statements. The Company’s subsidiary provides, at will, benefit contributions for its employees. 2) Vacation and recreation pay Under Israeli law, each employee in Israel is entitled to vacation days and recreation pay, both computed on an annual basis. This entitlement is based on the period of employment. The Company records expenses and liability for vacation and recreation pay based on the benefit accumulated by each employee. m. Share-based payments The Company operates several equity-settled, share-based compensation plans to employees (as defined in IFRS 2 “Share-Based Payments”) and service providers. As part of the plans, the Company grants employees and service providers, from time to time and at its discretion, options to purchase Company shares. The fair value of the employee and service provider services received in exchange for the grant of the options is recognized as an expense in profit or loss and is recorded as accumulated deficit within equity. For employees, the total amount recognized as an expense over the vesting period of the options (the period during which all vesting conditions are expected to be met) is determined by reference to the fair value of the options granted at the date of grant. For service providers (including equity instruments granted in consideration for intangible assets, see note 16(4), the Company measures the awards based on the fair value of the asset or service received. Vesting conditions are included in the assumptions about the number of options that are expected to vest. The total expense is recognized over the vesting period, which is the period over which all of the specified vesting conditions are to be satisfied. At the end of each reporting period, the Company revises its estimates of the number of options that are expected to vest based on non-market vesting conditions. The Company recognizes the impact of the revision to original estimates, if any, in profit or loss, with a corresponding adjustment to accumulated deficit. When exercising options, the Company issues new shares. The proceeds, less directly attributable transaction costs, are recognized as share capital (par value) and share premium. n. Revenue from contracts with customers The Company generated revenue in the years presented in these financial statements from product sales, including in-licensed products, and from promotional services provided in relation to third-party products. 1) Revenue from the sale of products The Company sells products mainly to wholesale distributors. Revenue is recognized at a point in time when control over the product is transferred to the customer (upon delivery), at the net selling price, which reflects reserves for variable consideration, including discounts and allowances. The transaction price in these arrangements is the consideration to which the Company expects to be entitled from the customer. The consideration promised in a contract with the Company’s customers may include fixed amounts and variable amounts. The Company estimates the variable consideration and includes it in the transaction price using the most likely outcome method, and only to the extent it is highly probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The specific considerations the Company uses in estimating these amounts related to variable consideration are as follows: Trade discounts and distribution fees Rebates and patient discount programs. Product returns. Principal versus agent considerations 2) Revenue from promotional services In 2020, the Company terminated the promotional agreements and recognized immaterial revenues from promotional services. In 2019 the Company recognized revenue from promotional services as it satisfied its performance obligation over time, in an amount equal to the consideration to which it expected to be entitled to, taking into consideration the constraint on variable considerations stipulated in IFRS 15. 3) Practical expedients and exemptions The Company expenses sales commissions when incurred since the amortization period of the asset that the Company otherwise would have recognized would have been for less than one year. These costs are recorded as selling and marketing expenses. o. Advertising and promotional expenses Advertising and promotional costs include, among others, distribution of free p. Loss per ordinary share The computation of basic loss per share is based on the Company’s loss divided by the weighted average number of ordinary shares outstanding during the period. In calculating the diluted loss per share, the Company adds the weighted average of the number of shares to be issued to the average number of shares outstanding used to calculate the basic loss per share, assuming all shares that have a potentially dilutive effect have been exercised into shares. q. Deferred taxes Deferred income tax is recognized using the liability method for temporary differences arising between the tax bases of assets and liabilities and their carrying amounts in these financial statements. Deferred income tax is determined using tax rates (and laws) that have been enacted or substantially enacted by the date of the Statements of Financial Position and are expected to apply when the related deferred income tax asset will be realized, or the deferred income tax liability will be settled. Deferred income tax assets are recognized only to the extent that it is probable that future taxable profit will be available against which the temporary differences can be utilized. Since the Company is unable to assess whether it will have taxable income in the foreseeable future, no deferred tax assets were recorded in these financial statements. r. Leases From January 1, 2019, the leases are recognized as a right-of-use asset and a corresponding liability at the date at which the leased asset is available for use by the Company. Each lease payment is allocated between the liability and finance cost. The finance cost is charged to profit or loss over the lease period so as to produce a constant periodic rate of interest on the remaining balance of the liability for each period. The right-of-use asset is depreciated over the shorter of the asset’s useful life and the lease term on a straight-line basis. Assets and liabilities arising from a lease are initially measured on a present value basis. Lease liabilities include the net present value of the following lease payments: fixed payments (including in-substance fixed payments) and variable lease payments that are based on an index or a rate. The lease payments are discounted using the lessee’s incremental borrowing rate, being the rate that the lessee would have to pay to borrow the funds necessary to obtain an asset of similar value in a similar economic environment with similar terms and conditions. Right-of-use assets are measured at cost being the amount of the initial measurement of the lease liability. Payments associated with short-term leases and leases of low-value assets are not recognized as right-of-use assets or lease liabilities but are recognized on a straight-line basis as an expense in profit or loss. Short-term leases are leases with a lease term of 12 months or less. Low-value assets include IT-equipment and small items of office furniture. Contracts may contain both lease and non-lease components. For leases of properties, the Company allocates the consideration in the contract to the lease and non-lease components based on their relative stand-alone prices. However, for leases of vehicles, for which the Company is a lessee, it has elected not to separate lease and non-lease components and instead accounts for these as a single lease component. s. Recently issued accounting pronouncements: 1) Amendments to IAS 1 regarding classifying liabilities as current or non-current In January 2020, the IASB issued amendment to IAS 1 to specify the requirements for classifying liabilities as current or non-current. The amendments clarify: the definition of a right to defer a settlement, that a right to defer must exist at the end of the reporting period, that classification is unaffected by the likelihood that an entity will exercise its deferral right, that only if an embedded derivative in a convertible liability is itself an equity instrument would the terms of a liability not impact its classification. The amendment is effective for annual periods beginning on or after January 1, 2023. At this stage the Company cannot evaluate the effect of the amendment on the financial statements. 2) Amendments to IFRS 9, IFRS 7, IFRS 16, IFRS 4 and IAS 39 regarding the IBOR reform In August 2020, the IASB issued amendments to IFRS 9, “Financial Instruments”, IFRS 7, “Financial Instruments: Disclosures”, IAS 39, “Financial Instruments: Recognition and Measurement”, IFRS 4, “Insurance Contracts”, and IFRS 16, “Leases” (“IBOR Amendments”). The IBOR Amendments provide practical expedients when accounting for the effects of the replacement of benchmark InterBank Offered Rates (IBORs) by alternative Risk-Free Interest Rates (RFRs). Pursuant to one of the practical expedients, an entity will treat contractual changes or changes to cash flows that are directly required by the reform as changes to a floating interest rate. That is, an entity recognizes the changes in interest rates as an adjustment of the effective interest rate without adjusting the carrying amount of the financial instrument. The use of this practical expedient is subject to the condition that the transition from IBOR to RFR takes place on an economically equivalent basis. The IBOR Amendments include new disclosure requirements in connection with the expected effect of the reform on an entity’s financial statements, such as how the entity is managing the process to transition to the interest rate reform, the risks to which it is exposed due to the reform and quantitative information about IBOR-referenced financial instruments that are expected to change. The IBOR Amendments are effective for annual periods beginning on or after January 1, 2021. The IBOR Amendments are to be applied retrospectively. However, restatement of comparative periods is not required. Early application is permitted. The Company adopted the IBOR amendments as from January 1, 2021. The adoption of the IBOR Amendment does not have an effect on the Company’s financial statements. |
CRITICAL ACCOUNTING ESTIMATES A
CRITICAL ACCOUNTING ESTIMATES AND JUDGMENTS | 12 Months Ended |
Dec. 31, 2021 | |
CRITICAL ACCOUNTING ESTIMATES AND JUDGMENTS | |
CRITICAL ACCOUNTING ESTIMATES AND JUDGMENTS | NOTE 3 - CRITICAL ACCOUNTING ESTIMATES AND JUDGMENTS: The preparation of financial statements requires management to make estimates which, by definition, will seldom equal the actual results and will affect the reported amounts in the Company’s consolidated financial statements and the accompanying notes. Some of the policies described in note 2 of the Company’s consolidated financial statements involve a high degree of judgment or complexity. The Company believes ● Recognition and measurement of allowance for rebates and patient discount programs ● Impairment reviews of intangible R&D assets . ● Estimated recoverable amount of the Aemcolo ® asset . ● Estimated useful life of the acquired assets in the Movantik ® acquisition. Recognition and measurement of allowance for rebates and patient discount programs The Company offers various rebate and patient discount programs, which result in discounted prescriptions to qualified patients. Rebates and discounts provided to the wholesalers and to the patients under these arrangements are accounted for as variable consideration, and recognized as a reduction in revenue, for which unsettled amounts are accrued. The allowance for these rebates is calculated based on historical and estimated utilization of the rebate and discount programs at the time the revenues are recognized. The main estimates used in recognizing and measuring this allowance relate to the amount of products sold to customers not yet prescribed to patients (units “in the channel”) and the mix of rebate and discount programs estimated for future prescription utilization. The Company periodically evaluates it estimates against actual results and, if necessary, updates the estimates accordingly. See also note14. Impairment reviews of intangible R&D assets The Company reviews annually or when events or changes in circumstances indicate the carrying value of the R&D assets may not be recoverable. When and if necessary, an impairment loss is recognized for the amount by which the asset’s carrying amount exceeds its recoverable amount. The recoverable amount is determined using discounted cash flow calculations where the asset’s expected post-tax cash flows are risk-adjusted over their estimated remaining useful economic life. The risk-adjusted cash flows are discounted using the estimated Company’s post-tax weighted average cost of capital (“WACC”) which is 16%. The main estimates used in calculating the recoverable amount include: outcome of the therapeutic candidates R&D activities; probability of success in gaining regulatory approval, size of the potential market and the Company’s asset’s specific share in it and amount and timing of projected future cash flows. Estimated recoverable amount of the Aemcolo ® asset The Aemcolo ® ® 1 ® ® Estimated useful life of the acquired assets in the Movantik ® acquisition In connection with the agreements mentioned in note 1a(2) above, the Company accounted for the acquisition of rights to Movantik ® ® ® 12.5 years |
FINANCIAL INSTRUMENTS AND FINAN
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT | 12 Months Ended |
Dec. 31, 2021 | |
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT | |
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT | NOTE 4 - FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT: Financial risk management: 1) Financial risk factors The Company’s activities expose it to a variety of financial risks: market risks (including foreign exchange risk and interest risk), credit risk and liquidity risk. The Company’s overall risk management program focuses on the unpredictability of financial markets and seeks to minimize potential adverse effects on the Company’s results of operations and financial position. Risk management is performed by the Chief Financial Officer of the Company who identifies and evaluates financial risks in close cooperation with the Company’s Chief Executive Officer. The Company’s finance department is responsible for carrying out financial risk management activities in accordance with policies approved by its BoD. The BoD provides general guidelines for overall financial risk management, as well as policies dealing with specific areas, such as exchange rate risk, interest rate risk, credit risk, use of financial instruments, and investment of excess cash. In order to minimize market risk and credit risk, the Company invests the majority of its cash balances in low-risk investments, such as (i) highly-rated bank deposits with terms of up to one-year term with exit points and (ii) a managed portfolio of select corporate bonds comprised of a diversified mix of highly-rated bonds. No more than 10% of the total value of the Company’s corporate bonds portfolio is invested in a single bond issuer. (a) Market risks (i) The Company could be exposed to foreign exchange risk as a result of its payments to employees and service providers and investment of some liquidity in currencies other than the U.S. dollar (i.e., the Functional Currency). The Company manages the foreign exchange risk by aligning the currencies for holding liquidity with the currencies of expected expenses, based on the expected cash flows of the Company. Had the Functional Currency of the Company been stronger by 5% against the NIS, assuming all other variables remained constant, the Company would have recognized a negligible a reduction in expenses in all the years presented in these financial statements. The foreign exchange risks associated with these balances are immaterial. (ii) The Company’s main interest rate risk arises from long-term borrowing with interest on the outstanding loan computed as the 3-month USD LIBOR rate (hereinafter – the “LIBOR”), subject to a 1.75% floor rate, plus 8.2% fixed rate, which was decreased to 6.7%, starting April 1, 2021. The Company regularly monitors the LIBOR, as well as the LIBOR forward curve. Based on that, the Company estimates that the 1.75% floor rate will remain effective (i.e. – LIBOR will remain below 1.75%) throughout the entire period of the borrowing and therefore the interest rate on this loan is effectively fixed. In July 2017, the United Kingdom’s Financial Conduct Authority (“FCA”), which regulates LIBOR, announced its intention to stop compelling the group of major banks that sustain LIBOR to submit rate quotations after the end of 2021 (the “LIBOR Reform”). ICE Benchmark Administration Limited (IBA), the administrator of the LIBOR, intends to cease the publication of the LIBOR settings immediately following the LIBOR publication on June 30, 2023. The IBA noted that any publication of the LIBOR settings based on panel bank submissions beyond December 31, 2021, will need to comply with applicable regulations, including as to representativeness. Based on current information from panel banks, IBA anticipates there being a representative panel for the continuation of these USD LIBOR settings through to June 30, 2023. As described above and in note 15, the Company’s long-term borrowing, which matures in 2026, is linked to the LIBOR. It is unclear whether new methods of calculating LIBOR will be established or if alternative benchmark reference rates will be adopted. The borrowing agreement stipulates that if the administrator responsible for determining and publishing the LIBOR has made a public announcement identifying a date certain on or after which such rate shall no longer be provided or published, as the case may be, then the lender may, upon prior written notice to the Company, choose a reasonably comparable index or source to enable to preserve the current all-in yield (including interest rate margins, any interest rate floors and original issue discount, but without regard to future fluctuations of such alternative index). As mentioned above, and despite the LIBOR Reform, the Company estimates that the effective floor rate will remain 1.75% throughout the entire period of the borrowing. (b) Credit risk Credit risk arises Credit risk of trade receivables is the risk that customers may fail to pay their debts. The Company manages credit risk by setting credit limits, performing controls and monitoring qualitative and quantitative indicators of trade receivable balances such as the period of credit taken and overdue payments. Customer credit risk also arises as a result of the concentration of the Company’s revenues with its largest customers. See also note 25(b). The Company’s vast majority of sales is to three U.S.-based large wholesale customers, which their historical loss rate is practically zero. Based on the above information, as well as analyzing if there is any relevant forward-looking information related to the Company’s customers, the Company did not record a loss allowance for trade receivables as of December 31, 202 1 20 (c) Liquidity risk Prudent liquidity risk management requires maintaining sufficient cash or the availability of funding through an adequate amount of committed credit facilities. Management monitors rolling forecasts of the Company’s liquidity reserve (comprising of cash and cash equivalents As of December 31, 2021, the Company has generated revenues from commercialization activities, however no sufficient revenue was generated to compensate for operating expenses and therefore the Company is exposed to liquidity risk. The tables below break down the Company’s financial liabilities into relevant maturity groupings based on their contractual and estimated maturities. The amounts disclosed in the tables are the contractual and estimated undiscounted cash flows. Contractual maturities of financial liabilities At 31 December 2021 Less than 1 year 2-5 years More than 5 years Total contractual cash flows Carrying amount U.S. Dollars in Thousands Accounts payable 11,664 11,664 11,664 Lease liabilities 2,109 2,553 4,662 4,192 Accrued expenses and other current liabilities 20,896 20,896 20,896 Borrowing 9,159 107,213 9,000 125,371 83,620 Payable in respect of intangible assets purchase 17,600 5,000 22,600 20,480 Royalty obligation - 1,011 1,351 2,362 750 Contractual maturities of financial liabilities At 31 December 2020 Less than 1 year 2-5 years More than 5 years Total contractual cash flows Carrying amount U.S. Dollars in Thousands Accounts payable 11,553 11,553 11,553 Lease liabilities 1,985 4,210 — 6,195 5,517 Accrued expenses and other current liabilities 24,082 24,082 24,082 Borrowing 10,154 107,514 18,530 136,198 81,386 Payable in respect of intangible assets purchase 20,600 10,000 30,600 24,745 Royalty obligation 127 747 912 1,786 750 2) Capital risk management The Company’s objectives when managing capital are to safeguard the Company’s ability to continue as a going concern in order to provide returns for shareholders, maintain optimal capital structure, and to reduce the cost of capital. As discussed in note 3) Fair value estimation As of December 31, 2020, the Company had an immaterial balance of assets measured at fair value through profit or loss, all based on quoted prices (unadjusted) in active markets for identical assets (level 1). The carrying amount of cash equivalents, restricted cash, bank deposits, receivables, account payables and accrued expenses approximate their fair value due to their short-term characteristics. The fair values of the Borrowing and the Payable in respect of intangible assets purchase balances as of December 31, 2021, are approximately $96 million and $23 million (as of December 31, 2020-$94 million and $26 million, respectively). These fair values are based on discounted cash flows using a current borrowing rate. The fair value of the Royalty obligation balance is not materially different from its carrying amount. |
CASH AND CASH EQUIVALENTS
CASH AND CASH EQUIVALENTS | 12 Months Ended |
Dec. 31, 2021 | |
CASH AND CASH EQUIVALENTS. | |
CASH AND CASH EQUIVALENTS | NOTE 5 - CASH AND CASH EQUIVALENTS: December 31, 2021 2020 U.S. dollars in thousands Cash in bank 28,890 14,265 Short-term bank deposits 584 15,030 29,474 29,295 The carrying amounts of the cash and cash equivalents approximate their fair values. |
FINANCIAL ASSETS AT FAIR VALUE
FINANCIAL ASSETS AT FAIR VALUE THROUGH PROFIT OR LOSS | 12 Months Ended |
Dec. 31, 2021 | |
FINANCIAL ASSETS AT FAIR VALUE THROUGH PROFIT OR LOSS. | |
FINANCIAL ASSETS AT FAIR VALUE THROUGH PROFIT OR LOSS | NOTE 6 – FINANCIAL ASSETS AT FAIR VALUE THROUGH PROFIT OR LOSS There are no financial assets as of December 31, 202 1 The Company’s business model regarding this portfolio is to realize cash flows through the sale of its assets, rather than hold these assets to collect their contractual cash flows or both to collect contractual cash flows and to sell these financial assets. The Company is primarily focused on fair value information and uses that information to assess the assets’ performance and to make decisions. Therefore, this portfolio is classified as financial assets at fair value through profit or loss. The fair value of the securities is based on their exchange market price at the end of each trading day and reporting period. |
PREPAID EXPENSES AND OTHER RECE
PREPAID EXPENSES AND OTHER RECEIVABLES | 12 Months Ended |
Dec. 31, 2021 | |
PREPAID EXPENSES AND OTHER RECEIVABLES | |
PREPAID EXPENSES AND OTHER RECEIVABLES | NOTE 7 - PREPAID EXPENSES AND OTHER RECEIVABLES: December 31, 2021 2020 U.S. dollars in thousands Advance to suppliers 632 2,543 Government institutions 847 634 Prepaid expenses and others 3,182 2,344 4,661 5,521 The fair value of other receivables, which constitute of financial assets, approximate their carrying amount. |
INVENTORY
INVENTORY | 12 Months Ended |
Dec. 31, 2021 | |
INVENTORY | |
INVENTORY | NOTE 8 - INVENTORY: December 31, 2021 2020 U.S. dollars in thousands Raw materials 3,012 1,792 Work in progress 5,195 — Finished goods 6,603 4,734 14,810 6,526 During the years ended December 31, 20 2 7.7 Write-downs of inventories to net realizable value amounted to $ 0.3 2 |
FIXED ASSETS
FIXED ASSETS | 12 Months Ended |
Dec. 31, 2021 | |
FIXED ASSETS | |
FIXED ASSETS | NOTE 9 - FIXED ASSETS: The composition of assets and accumulated depreciation are grouped by major classifications: Cost Accumulated depreciation Depreciated balance December 31 December 31 December 31 2021 2020 2021 2020 2021 2020 U.S. dollars in thousands Office furniture and equipment (including computers) 1,024 753 677 479 347 274 Leasehold improvements 357 357 132 120 225 237 1,381 1,110 809 599 572 511 |
LEASES
LEASES | 12 Months Ended |
Dec. 31, 2021 | |
LEASES | |
LEASES | NOTE 10 - LEASES: Amounts recognized in the consolidated statements of financial position: Year Ended December 31, 2021 2020 U.S dollars in thousands Right-of-use assets: Properties 1,986 2,593 Vehicles 1,665 2,599 3,651 5,192 Lease liabilities: Current 1,618 1,710 Non-current 2,574 3,807 4,192 5,517 Additions to the right-of-use assets and lease liabilities during the years ended 2021 2020 Amounts recognized in the consolidated statements of comprehensive loss: Year Ended December 31, 2021 2020 Depreciation charge of right-of-use assets Properties 608 607 Vehicles 1,282 948 1,890 1,555 Interest expense (included in financial expenses) 397 574 Expenses relating to short-term leases and leases of low-value assets are immaterial. The total cash outflow for leases in 2021 and 2020 was $1.9 million and $2 million respectively. |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 12 Months Ended |
Dec. 31, 2021 | |
INTANGIBLE ASSETS | |
INTANGIBLE ASSETS | NOTE 11 - INTANGIBLE ASSETS: a. Commercialization ® ® Year Ended December 31, 2021 2020 U.S. dollars in thousands R&D assets: Cost: Balance at beginning of year 5,757 5,355 Additions during the year — 402 Balance at end of year 5,757 5,757 Accumulated amortization: Balance at beginning of year (50) — Amortization charges (66) (50) Balance at end of year (116) (50) 5,641 5,707 Commercialization assets: Cost: Balance at beginning of year 89,373 11,788 Additions during the year see notes 16(4) - 16(6) — 77,585 Balance at end of year 89,373 89,373 Accumulated impairments and amortization: Balance at beginning of year (7,201) (216) Amortization and impairment charges see (b) below (16,169) (6,985) Balance at end of year (23,370) (7,201) 66,003 82,172 71,644 87,879 The Company estimated the useful life of assets related to Movantik ® 10.5 years 12.5 years ® ® b. Intangible assets impairment: Following the prolongation of the COVID-19 pandemic and its significant impact on worldwide travel, the Company expects a continued decrease in U.S. outbound travel and the potential market for Aemcolo ® ® ® Company’s investment in the asset. The impairment loss was recognized under Cost of Revenues in the Consolidated Statements of Comprehensive Loss. As there were no indicators for impairment of any of the other amortized intangible assets, the Company did not specifically evaluate their recoverable amounts. |
LIABILITY FOR EMPLOYEE RIGHTS U
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT | 12 Months Ended |
Dec. 31, 2021 | |
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT | |
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT | NOTE 12 - LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT: a. Labor laws and agreements in Israel require the Company to pay severance pay and/or pensions to an employee dismissed or retiring from their employment in certain circumstances. b. The Company’s pension liability and the Company’s liability for payment of severance pay for employees in Israel for whom the liability is within the scope of Section 14 of the Severance Pay Law, is covered by ongoing deposits with defined contribution plans. The amounts deposited are not included in the Statements of Financial Position. The amounts charged as an expense with respect to defined contribution plans in 2021, 2020, and 2019 were $285,000, $214,000, and $184,000, respectively. |
ACCRUED EXPENSES AND OTHER CURR
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | 12 Months Ended |
Dec. 31, 2021 | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | NOTE 13 - ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES: December 31, 2021 2020 U.S. dollars in thousands Accrued expenses 17,234 18,972 Employees and related liabilities 3,496 4,963 Government institutions 167 147 20,896 24,082 |
ALLOWANCE FOR DEDUCTIONS FROM R
ALLOWANCE FOR DEDUCTIONS FROM REVENUES | 12 Months Ended |
Dec. 31, 2021 | |
ALLOWANCE FOR DEDUCTIONS FROM REVENUES | |
ALLOWANCE FOR DEDUCTIONS FROM REVENUES | NOTE 14 - ALLOWANCE FOR DEDUCTIONS FROM REVENUES: The following table shows the movement of the allowance for deductions from revenue: Rebates and patient discount programs Product returns Total U.S. dollars in thousands As of January 1, 2021 16,380 1,963 18,343 Increases 94,640 851 95,491 Decreases (utilized) (80,633) (2,179) (82,812) Adjustments (645) 334 (311) As of December 31, 2021 29,742 969 30,711 Rebates and patient discount programs Product returns Total U.S. dollars in thousands As of January 1, 2020 1,001 266 1,267 Increases 56,669 2,469 59,138 Decreases (utilized) (40,656) (772) (41,428) Adjustments (634) - (634) As of December 31, 2020 16,380 1,963 18,343 Rebates and patient discount programs Product returns Total U.S. dollars in thousands As of January 1, 2019 573 385 958 Increases 2,485 303 2,788 Decreases (utilized) (2,057) (72) (2,129) Adjustments - (350) (350) As of December 31, 2019 1,001 266 1,267 |
BORROWING
BORROWING | 12 Months Ended |
Dec. 31, 2021 | |
BORROWING. | |
BORROWING | NOTE 15 – BORROWING: a. General On February 23, 2020 (“Closing Date”) RedHill Inc. entered into a credit agreement and certain security documents (the “Credit Agreement”) with HCR Collateral Management, LLC (“HCRM”). Under the terms of the Credit Agreement, RedHill Inc. received on March 12, 2020, a $30 million term loan to support its commercial operations. On March 31, 2020, RedHill Inc. received an additional $50 million term loan to fund the acquisition of rights to Movantik ® For each quarter for the period from January 1, 2021, to December 31, 2029, HCRM will receive royalties of 4% of the Company’s worldwide net revenues, subject to a $75 million cap per annum, as well as interest on the outstanding term loan to be computed as the 3-month LIBOR rate (“LIBOR”), subject to a 1.75% floor rate, plus 8.2% fixed rate, which was decreased to 6.7% starting April 1, 2021. The term loans mature in six years with no principal payments required in the first three years. The term loans can be prepaid at RedHill Inc.’s discretion, subject to customary prepayment fees, which decrease over time. Upon the prepayment or repayment of all or any portion of the term loans, RedHill Inc. will pay HCRM 4% on the principal amount of the term loan being repaid or prepaid as an exit fee. The borrowings under the Credit Agreement are secured by a first priority lien on substantially all of the current and future assets of RedHill Inc., all assets related in any material respect to Talicia ® The Credit Agreement contains certain customary affirmative and negative covenants, which were all met as of December 31, 2021. The Credit Agreement also contains a financial covenant requiring RedHill Inc. to maintain a minimum level of cash, as well as a covenant requiring it to maintain minimum net sales for the trailing four fiscal quarter periods, beginning with the fiscal quarter ending June 30, 2022. The minimum level of cash is relative to the amount borrowed under the term loan facility. The Credit Agreement contains defined events of default, in certain cases subject to a grace period, following which the lenders may declare any outstanding principal and unpaid interest immediately due and payable. As of December 31, 2021, the minimum level of cash, which relates to the term loans is $16 million. This amount is presented as restricted cash on the consolidated statement of financial position. b. Accounting treatment A financial liability is recognized for each tranche upon drawdown, at the amount drawn less transaction costs attributable to that tranche. Upon initial recognition, the effective interest rate is calculated by estimating the future cash flows throughout the expected life of that tranche, taking into account the transaction costs allocated to each tranche. The Company determined that the basis of the royalty payments due to HCRM, the Company’s worldwide net revenues, is a non-financial variable and specific to the Company. Moreover, the royalty feature is an integral part of the terms and conditions of the term loans and cannot be transferred or settled separately from the term loan. Therefore, the royalties feature is not classified separately, does not meet the definition of a derivative, and is not measured separately. Instead, the royalty feature and other net revenues features are taken into account in estimating the effective interest rate. Determining the weighted effective interest rate requires certain judgment related to the estimation of the timing and amounts of the Company’s future worldwide net revenues. The weighted effective interest rate on the Closing Date was approximately 16.5%. Each tranche drawn down is subsequently measured at amortized cost. The effective interest rate is re-estimated at each interest rate determination date, as defined in the Credit Agreement, by updating per the LIBOR, if needed, taking into account the LIBOR floor (that is considered to be closely related to the host debt contract and is not separated from the host debt). Furthermore, revisions to estimated amounts or timing of future cash flows, if needed, shall adjust the amortized cost of each tranche drawn down to reflect the present value of actual and revised estimated contractual cash flows, discounted using the original effective interest rate (adjusted for changes in the LIBOR, as described above). The adjustment will be recognized in profit or loss as a financial income or expense. As described above, the Credit Agreement contains a financial covenant requiring the Company to maintain a level of cash liquidity, on any business day from the Closing Date to the maturity date, in accounts that are subject to HCRM’s control. Therefore, the amounts of minimum cash and cash equivalents are excluded from cash and cash equivalents in the Statements of Financial Position and the Statements of Cash Flows. Instead, these amounts are presented as restricted cash in the Statements of Financial Position and the movements in this restricted cash are presented as financing activities in the Statements of Cash Flows. The minimum cash amounts Further details of the Company’s exposure to risks arising from the Credit Agreement, as well as maturities and fair value information, are set out in note 4. C. Reconciliation of liabilities arising from financing activities: Non-cash changes U.S. dollars in thousands January 1, 2021 Proceeds from borrowings Principal and interest payments Addition during the year Interest expense Foreign exchange movement December 31, 2021 Borrowing $81,386 ($9,701) $11,935 $83,620 Payable in respect of intangible assets purchase $24,746 ($8,500) $4,234 $20,480 Lease liabilities $5,517 ($2,107) $385 355 42 $4,192 Non-cash changes January 1, 2020 Proceeds from borrowings Principal and interest payments Addition during the year Interest expense Foreign exchange movement December 31, 2020 Borrowing - $78,061 ($6,246) $9,571 $81,386 Payable in respect of intangible assets purchase - $22,288 $2,458 $24,746 Lease liabilities $3,815 ($1,802) $2,930 $406 $168 $5,517 Non-cash changes January 1, 2019 Proceeds from borrowings Principal and interest payments Addition during the year Interest expense Foreign exchange movement December 31, 2019 Lease liabilities $1,667 ($1,047) $2,805 $251 $139 $3,815 |
COMMITMENTS
COMMITMENTS | 12 Months Ended |
Dec. 31, 2021 | |
COMMITMENTS | |
COMMITMENTS | NOTE 16 - COMMITMENTS: Agreements to purchase intellectual property and commercial products: 1) On August 11, 2010, the Company entered into an agreement with a publicly-traded Australian company in an asset purchase agreement to acquire intellectual property relating to three therapeutic candidates for the treatment of gastrointestinal conditions. Pursuant to the asset purchase agreement, as amended, the Company paid the Australian company an initial amount of $500,000 and undertook to pay future payments in the range of 7% - 20% from the Company’s revenues that may be generated from the sale and sublicense of the therapeutic candidates, less certain deductible amounts, as detailed in the agreement. Such potential payments are due until termination or expiration of the last of the patents transferred to the Company pursuant to the agreement (each on a product-by-product basis). Through December 31, 2021, the Company has paid the Australian company in total $1.5 million. 2) On June 30, 2014, the Company entered into an agreement with a German company that granted the Company the exclusive worldwide (excluding China, Hong Kong, Taiwan, and Macao) development and commercialization rights to all indications to a therapeutic candidate. Under the terms of the agreement, the Company paid the German company an upfront payment of $1 million and agreed to pay the German company potential tiered royalties, less certain deductible amounts, as detailed in the agreement, ranging from mid-teens and up to 30%. Such potential royalties are due until the later of (i) the expiration of the last to expire licensed patent that covers the product in the relevant country and (ii) the expiration of regulatory exclusivity in the relevant country. Through December 31, 202 1 3) On March 30, 2015, the Company entered into an agreement with a U.S.-based private company that granted the Company the exclusive worldwide development and commercialization rights for all indications to a therapeutic candidate, and additional intellectual property rights, targeting multiple oncology, inflammatory and GI indications. Under the terms of the agreement, the Company undertook to pay the U.S. company an initial amount of $1.5 million and an additional amount of $2 million to be paid on a specific date. In addition, the Company undertook to pay up to $2 million in potential development milestone payments, and potential tiered royalties on revenues, less certain deductible amounts starting in the low double-digits, as detailed in the agreement. Such potential royalties are due until the later of (i) the expiration of the last to expire licensed patent that covers the product in the relevant country; and (ii) the expiration of regulatory exclusivity in the relevant country. Through December 31, 2021, the Company paid the U.S. company a total of $3 million. Following 4) On October 17, 2019, the Company entered into a strategic collaboration with Cosmo Pharmaceuticals N.V. (“Cosmo”), which includes an exclusive license agreement, as amended, for the U.S. rights to Aemcolo ® Under the terms of the license agreement, Cosmo invested $36.3 million in cash and granted the Company the exclusive rights to commercialize Aemcolo ® The license agreement also grants the Company certain rights related to the potential development of additional indications for Aemcolo ® ® With respect to this agreement, the Company measured the commercialization rights based on their fair value (approximately $11.8 million, as of the date of the acquisition) with a corresponding credit to equity. See also note 11(b). 5) Movantik ® acquisition: 1. General In connection with the agreements mentioned in note 1a(2), on April 1, 2020 (“Effective Date”), RedHill Inc. made an upfront payment of $52.5 million to AstraZeneca, and the AstraZeneca License Agreement, the Supply Agreement and the TSA became effective. Under the terms of the AstraZeneca License Agreement, as amended on July 14, 2020, RedHill Inc. agreed to pay a further non-contingent payment of $15.5 million in December 2021. On March 11, 2021, RedHill Inc and AstraZeneca signed an amendment to the License Agreement, pursuant to which, the $15.5 million payment due in December 2021 was adjusted to gradual payments starting in March 2021 and ending in December 2022, totaling $16 million. The amendment is not considered a substantial modification of the terms and resulted in an adjustment of approximately $0.5 million in the carrying amount of the payable in respect of intangible assets purchase and a corresponding charge in the consolidated statements of comprehensive loss, under financial expenses. RedHill Inc. will also assume responsibility for sales-based royalty, currently at a rate of 20%, as well as sales-based potential milestone payments that AstraZeneca is required to pay to Nektar Therapeutics (“Nektar”), the originator of Movantik ® In addition, AstraZeneca transferred on the Effective Date to RedHill Inc. a co-commercialization agreement with Daiichi Sankyo, Inc. (“DSI”) for Movantik ® ® Under its Supply Agreement with AstraZeneca used in connection with its commercialization of Movantik ® ® On February 22, 2021, Aether Therapeutics Inc. (“Aether”), filed a complaint against RedHill Inc in the United States District Court for the District of Delaware ("Aether Litigation"). The complaint asserts that the Company's marketing of the Movantik ® ® 2. Accounting treatment The Company, in accordance with IFRS 3 – Business Combinations and IAS 38 – Intangible Assets, accounted for the acquisition of rights to Movantik ® (a) The Supply Agreement provides RedHill Inc. with the ability to purchase finished products and materials from AstraZeneca during a transition period at approximately fair value, without acquiring AstraZeneca's organized workforce or existing processes required to manufacture Movantik ® (b) The TSA is intended to allow a smooth transition of the different activities related to Movantik ® for a relatively short period and is not intended for RedHill Inc. to acquire AstraZeneca's organized workforce, supply chain or distribution processes. The TSA had terminated on September 30, 2020. (c) In addition, the Company determined that the concentration test under the new definition of a business is met, since substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. (the rights to produce and sell Movantik®). Therefore, the Movantik® acquisition does not represent a business combination, rather than an asset acquisition. The total acquisition consideration, including upfront payment, discounted present value of the deferred payment and directly attributable transaction costs amounted to approximately $65 million. Since all acquired assets are intended to generate revenues from sales of Movantik ® and have a similar useful life, the Company attributed this consideration to a single intangible asset representing the acquired rights to Movantik ® . The intangible asset shall be amortized commencing the Effective Date on a straight-line basis over its useful life, which was re-estimated at approximately 12.5 years from the Effective Date (see also note 11(a) with regards to change in estimation of the useful life). With respect to sales-based royalties and milestone payments aforementioned, the Company applied an accounting policy, pursuant to which these variable payments shall not be included in the initial measurement of the cost of the intangible asset acquired, as they are not a present obligation of RedHill Inc. Through September 30, 2020, AstraZeneca provided, among other services, Sales Order-To-Cash (SOTC) services. During this period, AstraZeneca remitted to RedHill Inc. the Sales Margin, as defined in the TSA, for the products sold and RedHill Inc. paid a fee of 4.5% of Net Revenues, as well as non-sales-based fees and out-of-pocket costs for the services rendered. During the SOTC period, the Company recognized revenues in the gross amount of consideration to which it expects to be entitled in exchange for the finished products transferred to the customers (the wholesalers). The fees and out-of-pocket costs were expensed as incurred. Starting October 1, 2020, AstraZeneca no longer provided the abovementioned services . 6) As described in note 16 (5) above, as part of the Movantik ® ® Effective July 1, 2020, RedHill Inc. and DSI replaced the co-commercialization agreement with a new royalty-bearing agreement, under which RedHill Inc. bears all responsibilities and costs for commercializing Movantik ® in the U.S. During the term of this new agreement, RedHill Inc. will pay DSI a mid-teen royalty rate on net sales of Movantik ® in the U.S. in addition to $5.1 million paid in January 2022 and $5 million to be paid in July of each of the years 2022 and 2023. Concurrently, the Company also entered into a security purchase agreement, under which DSI received 283,387 ADSs as a partial consideration in relation to Movantik ® . The Company recognized an intangible asset in the amount of approximately $12.5 million. This amount includes approximately $10.5 million for the present value of the above-mentioned payments, recognized against a corresponding financial liability and approximately $2 million for the ADSs issued to DSI. The intangible asset recognized has similar estimated useful life as the intangible asset discussed in note 16 (5) above and are amortized on a straight-line basis over its useful life. 7) As for an exclusive license agreement with Gaelan Medical Trade LLC for Talicia® in the United Arab Emirates (UAE) - see Note 28b. |
INCOME TAX
INCOME TAX | 12 Months Ended |
Dec. 31, 2021 | |
INCOME TAX | |
INCOME TAX | NOTE 17 - INCOME TAX: a. Taxation of the Company in Israel: 1) Measurement of results for tax purposes The Company elected to compute its taxable income in accordance with Income Tax Regulations (Rules for Accounting for Foreign Investors Companies and Certain Partnerships and Setting their Taxable Income), 1986. Accordingly, the Company’s taxable income or loss is calculated in U.S. dollars. The results of the Company are measured for tax purposes in accordance with Accounting Principles Generally Accepted in Israel (Israeli GAAP). These financial statements are prepared in accordance with IFRS. The differences between IFRS and Israeli GAAP, both on an annual and a cumulative basis cause differences between taxable results and the results are reflected in these financial statements. 2) Tax rates The net income of the Company is subject to the Israeli corporate tax rate. Israeli corporate tax rates is 23%. b. U.S. subsidiary: The Company’s subsidiary is incorporated in the U.S. and is taxed under U.S. tax laws. As a general rule, inter-company transactions between the Israel-resident Company and its U.S-resident subsidiary are subject to the reporting provisions of the Income Tax Regulations, section 85-A, 2006 of the Israeli Tax Ordinance of the Israeli Tax Ordinance. c Carryforward losses : As of December 31, 2021, the Company had net operating loss (“NOLs”) carried forward of approximately $265 million. Under Israeli tax laws, carryforward tax losses have no expiration date. As of December 31, 2021, the U.S. subsidiary had a net operating loss carryforward of approximately $77 million, of which approximately $10 million expires in 2037, and approximately $67 million does not expire, but is limited to offset 80% of the net income in the year it is utilized. Under U.S. tax laws, for NOLs arising after December 31, 2017, the 2017 Act limits a taxpayer’s ability to utilize NOL carryforwards to 80% of taxable income. In addition, NOLs arising after 2017 can be carried forward indefinitely, but carryback is generally prohibited. NOLs generated in tax years beginning before January 1, 2018, will not be subject to the foregoing taxable income limitation and will continue to have a two-year carryback and twenty-year carryforward period. Furthermore, in accordance with Coronavirus Aid, Relief, and Economic Security Act (CARES Act) of 2020, losses from tax years beginning in 2018, 2019 or 2020 can be carried back 5 years. Deferred tax assets on losses for tax purposes carried forward to subsequent years are recognized if utilization of the related tax benefit against a future taxable income is expected. The Company has not created deferred taxes on its carryforward losses since their utilization is not expected in the foreseeable future. d Deductible temporary differences: The amount of cumulative deductible temporary differences, other than carryforward losses (as mentioned in c. above), for which deferred tax assets have not been recognized in the Statements of Financial Position as of December 31, 2021, and 2020, were $20 million and $12 million, respectively. These temporary differences have no expiration dates. e Tax assessments: The Company has not been assessed for tax purposes since its incorporation. The Company’s tax assessments for 2016 are therefore considered final. |
SHARE CAPITAL
SHARE CAPITAL | 12 Months Ended |
Dec. 31, 2021 | |
SHARE CAPITAL | |
SHARE CAPITAL | NOTE 18 - SHARE CAPITAL: a. Composition: Company share capital is composed of shares of NIS 0.01 par value, as follows: Number of shares December 31, 2021 2020 In thousands Authorized ordinary shares 794,000 794,000 Authorized preferred shares (reserved) 6,000 6,000 Issued and paid ordinary shares 524,016 383,981 In May 2020, a general meeting of the Company’s shareholders approved the increase of the authorized share capital of the Company to 800,000,000 shares. Consisting of 794,000,000 Ordinary Shares, NIS 0.01 par value per share and 6,000,000 preferred shares, NIS 0.01 par value b. During 2021, the Company issued 12,522,245 ADSs from underwritten offerings for gross proceeds of approximately $77 million. Net proceeds to the Company from the offerings, following underwriting commissions and other offering expenses, were approximately $72.7 million. c. In October 2021, the Company has entered into an agreement with Kukbo Co. Ltd. (“Kukbo”), a South Korean corporation, for the sale of the Company’s ADSs in a private placement of up to $10 million. Kukbo’s investment in the Company is to be made in two tranches, with the first tranche of $5 million paid in October 2021 and the second tranche of $5 million to follow within six months, subject to satisfaction of certain conditions. As part of the first tranche, RedHill has issued 827,586 ADSs at a purchase price of $6.04 , which represented a 20% premium over the 30-day weighted average price of the ADSs on the Nasdaq. The $5 million consideration for the first tranche was attributed in full to equity, Likewise, the number of ADSs to be issued in the second tranche will be calculated based on a price per ADS representing a 20% premium over the 30-day weighted average at the closing. In addition, under the terms of the agreement, the Company has agreed to grant Kukbo a right of first offer, for a period of six months, for a license with respect to one or more of the Company’s late-stage clinical assets, Opaganib, RHB-107 (upamostat) and Talicia®, for one or more of the territories of South Korea, Japan, Indonesia, Vietnam, Thailand and Malaysia. Kukbo has the right to elect not to purchase the ADSs in the second tranche if no such license agreement is executed within six months of the closing of the first tranche. See also note 28(c). d . During 2021, the Company sold 87,624 ADSs under an “at-the-market” equity offering program (“ATM program”) at an average price of $9.03 per ADS. Net and gross proceeds to the Company were approximately $0.8 million. The sales are under the Company's sales agreements with SVB Leerink LLC and Cantor Fitzgerald & Co. Upon the terms and subject to the conditions and limitations in the sales agreements, the Company may elect from time to time, to offer and sell its ADSs having aggregate gross sales proceeds of up to $100 million through the ATM program, under which SVB Leerink LLC and Cantor Fitzgerald & Co act as the sales agents. During 2020, the Company sold 2,837,038 ADSs under an ATM program at an average price of $8.62 per ADS. Net proceeds to the Company, following issuance expenses of approximately $0.6 million, were approximately $23.8 million. e. f. In July 2020, as part of the transaction described in note above, the Company entered into a security purchase agreement with DSI and subsequently issued to DSI 283,387 ADSs for approximately $2 million. g. In October 2019, the Company, under the strategic collaboration discussed in note 16(4), issued 5,185,715 ADSs to Cosmo for proceeds in cash of $36.3 million and 1,714,286 ADSs to Cosmo Technologies Ltd, a wholly-owned subsidiary of Cosmo, as an upfront payment for the U.S commercialization rights of Aemcolo ® . |
SHARE-BASED PAYMENTS
SHARE-BASED PAYMENTS | 12 Months Ended |
Dec. 31, 2021 | |
SHARE-BASED PAYMENTS | |
SHARE-BASED PAYMENTS | NOTE 19 - SHARE-BASED PAYMENTS: On May 30, 2010, a general meeting of shareholders approved the option plan of the Company (the “Option Plan”), after being approved by the BoD. In 2017 the Option Plan was amended and restated as the 2010 Award Plan (the “Award Plan”). As of December 31, 2021, the Award Plan allows the Company to allocate up to 59,206,448 options to purchase ordinary shares to employees, consultants, and directors and are reserved by the BoD for issuance under the Award Plan. The terms and conditions of the grants were determined by the BoD and are according to the Award Plan. a. The following is information on options granted in 2021: Number of options granted According to the Award Plan Exercise Fair value of of the Company price for 1 options on date of Other than to ADS ($) grant in U.S. dollars Date of Grant directors (1) To directors (1)(2) Total in thousands (1)(2)(3) March 2021 40,500 — 40,500 9.44 151 April 2021 2,036,440 — 2,036,440 7.08 8,274 May 2021 22,500 — 22,500 7.05 90 July 2021 17,000 310,341 327,341 6.9-7.08 1,377 August 2021 53,500 53,500 6.97-7.18 210 September 2021 12,000 — 12,000 4.56 31 November 2021 24,500 — 24,500 4.54 63 December 2021 17,000 — 17,000 2.65 26 2,223,440 310,341 2,533,781 10,221 1) The options will vest as follows: for directors, employees and consultants of the Company and the Company's subsidiary who had provided services exceeding one year as of the grant date, options will vest in 16 equal quarterly installments over a four-year period. For directors, employees and consultants of the Company and the Company's subsidiary who had not provided services exceeding one year as of the grant date, the options will vest as follows: 1/4 The options are exercisable into the Company’s ADSs. 2) The general meeting of the Company’s shareholders held on July 26 1 3) The fair value of the options was computed using the binomial model and the underlying data used was mainly the following: price of the Company’s ADSs: $4.28 - $9.19, expected volatility: 64.05% - 66.65 %, risk-free interest rate: 1.26% 4) Exchange of options to purchase the Company’s ADSs: a. On April 26, 2021, the Company made an o ffer ( the “Exchange Offer”) to eligible option holders (as defined in the offer), subject to specified conditions, to exchange some or all of their outstanding options to purchase ADSs ( the “Exchanged Options”) for new options to purchase ADSs ( the “New Options” ). On May 26, 2021, concurrently with the expiration of the Exchange Offer, the Company granted New Options to purchase 2,805,281 ADSs of the Company, pursuant to the terms of the Exchange Offer and the Company’s Amended and Restated Award Plan (2010). The New Options have lower exercise price per ADS than the Exchanged Options and subject to meeting certain performance conditions, specified in the Exchange Offer, may be further lowered. Other than the exercise price, each New Option has the same expiration date, vesting schedule and other terms as the Exchanged Options . b. The incremental compensation expense recognized by the Company has been measured as the excess of the fair value of each New Option granted, as of the date the New Options were granted, over the fair value of the Exchanged Options, measured immediately prior to the exchange. The total incremental value measured by the Company is approximately $3.5 million, of which $3.3 million was recognized as an expense for the year ended December 31, 2021. The remaining incremental value will be recognized over the remaining vesting period of the New Options. c. b. The following is information on options granted in 2020: Number of options granted According to the Award Plan Exercise Fair value of of the Company price for 1 options on date of Other than to Ads grant in U.S. dollars Date of BoD directors (1) To directors (1) (2) Total ($) in thousands (3) January 2020 95,000 — 95,000 6.60 243 February 2020 52,500 — 52,500 6.05 119 March 2020 285,000 — 285,000 4.87 683 May 2020 143,000 219,000 362,000 7.50 1,118 June 2020 767,500 — 767,500 7.72 2,671 July 2020 12,500 — 12,500 7.69 45 August 2020 55,500 — 55,500 8.72 264 November 2020 21,000 — 21,000 10.20 90 1,432,000 219,000 1,651,000 5,233 1) The options vesting terms are as described in note 19(a)(1) above. 2) The general meeting of the Company’s shareholders held on May 4, 2020, subsequent to approval of the Company’s BoD, approved the grant of 219,000 options under the Company’s Award Plan, to directors and to the Company's Chief Executive Officer. 3) The fair value of the options was computed using the binomial model and the underlying data used was mainly the following: price of the Company’s ADSs: $4.28 - $9.19, expected volatility: 57.73% - 63.63%, risk-free interest rate: 0.64% - 1.51% and the expected term was derived based on the contractual term of the options, the expected exercise behavior and expected post-vesting forfeiture rates. the expected volatility assumption used in based on the historical volatility of the Company’s ordinary share. c. Changes in the number of options in ADSs and weighted averages of exercise prices are as follows: Year Ended December 31, 2021 2020 Weighted Weighted average of average of Number of exercise Number of exercise options price ($) options price ($) Outstanding at beginning of year 5,428,803 9.08 4,050,898 10.30 Exercised (565,998) 7.08 (8,156) 6.38 Expired and forfeited (575,095) 8.02 (264,939) 9.65 Granted 2,533,781 7.05 1,651,000 6.90 Outstanding at end of year 6,821,491 6.50 5,428,803 9.08 Exercisable at end of year 3,615,662 6.14 3,178,317 10.19 d. The following is information about the exercise price and remaining useful life of outstanding options at year-end: Year Ended December 31, 2021 2020 Number of Number of options Weighted options Weighted outstanding average of outstanding average of at end of Exercise price remaining at end of Exercise price remaining year range useful life year range useful life 6,821,491 $2.65-$15.6 6.8 5,428,803 $5.6-$16.1 5.9 e. Expenses recognized in profit or loss for the options are as follows: Year Ended December 31, 2021 2020 2019 U.S. dollars in thousands 10,212 4,202 3,027 The remaining compensation expenses as of December 31, 2021, are $7.6 million and will be expensed in full by September 2025. |
NET REVENUES
NET REVENUES | 12 Months Ended |
Dec. 31, 2021 | |
NET REVENUES | |
NET REVENUES | NOTE 20 - NET REVENUES: Year Ended December 31, 2021 2020 2019 U.S dollars in thousands Movantik® revenues 76,767 59,356 — Other products (1) 8,989 5,003 6,291 85,757 64,359 6,291 1) During 2019 $3.1 million were attributed to the promotional services, and $3.2 million, were attributed to commercialization of products. In 2020, the Company terminated the promotional agreements and recognized immaterial revenues from promotional services . |
RESEARCH AND DEVELOPMENT EXPENS
RESEARCH AND DEVELOPMENT EXPENSES | 12 Months Ended |
Dec. 31, 2021 | |
RESEARCH AND DEVELOPMENT EXPENSES. | |
RESEARCH AND DEVELOPMENT EXPENSES | NOTE 21 - RESEARCH AND DEVELOPMENT EXPENSES: Year Ended December 31, 2021 2020 2019 U.S. dollars in thousands Payroll and related expenses 839 636 623 Professional services 1,821 1,752 2,345 Share-based payments 1,910 883 671 Clinical and pre-clinical trials 23,905 12,569 12,840 Intellectual property development 349 298 317 Other 674 353 623 29,498 16,491 17,419 |
SELLING AND MARKETING EXPENSES
SELLING AND MARKETING EXPENSES | 12 Months Ended |
Dec. 31, 2021 | |
SELLING AND MARKETING EXPENSES | |
SELLING AND MARKETING EXPENSES | NOTE 22 - SELLING AND MARKETING EXPENSES: Year Ended December 31, 2021 2020 2019 U.S. dollars in thousands Payroll and related expenses 24,227 20,756 9,335 Share-based payments 2,570 1,464 941 Professional services 17,441 18,957 3,680 Samples 1,008 438 178 Travel, Fleet, meals and related expenses 7,305 5,729 2,193 Office-related expenses 1,285 957 789 Other 1,787 984 1,217 55,623 49,285 18,333 |
GENERAL AND ADMINISTRATIVE EXPE
GENERAL AND ADMINISTRATIVE EXPENSES | 12 Months Ended |
Dec. 31, 2021 | |
GENERAL AND ADMINISTRATIVE EXPENSES | |
GENERAL AND ADMINISTRATIVE EXPENSES | NOTE 23 - GENERAL AND ADMINISTRATIVE EXPENSES: Year Ended December 31, 2021 2020 2019 U.S. dollars in thousands Payroll and related expenses 11,974 11,159 4,903 Share-based payments 5,732 1,855 1,415 Professional services 11,040 9,132 3,479 Medical affairs 1,600 1,052 299 Office-related expenses 1,438 1,168 585 Other 581 1,009 800 32,365 25,375 11,481 |
FINANCIAL EXPENSES (INCOME), ne
FINANCIAL EXPENSES (INCOME), net | 12 Months Ended |
Dec. 31, 2021 | |
FINANCIAL EXPENSES (INCOME), net | |
FINANCIAL EXPENSES (INCOME), net | NOTE 24 - FINANCIAL EXPENSES (INCOME), net : Year Ended December 31, 2021 2020 2019 U.S dollars in thousands Financial income: Fair value gains on derivative financial instruments — — 344 Gains on financial assets at fair value through profit or loss — 94 474 Gains from changes in exchange rates — — 74 Interest from bank deposits 51 176 443 51 270 1,335 Financial expenses: Interest and finance charges for lease liabilities 395 405 390 Loss from changes in exchange rates 28 9 — Interest expenses related to borrowing and payable in respect of intangible assets purchase 16,172 12,045 — Other 65 300 48 16,660 12,759 438 Financial expenses (income), 16,609 12,489 (897) |
SEGMENT INFORMATION
SEGMENT INFORMATION | 12 Months Ended |
Dec. 31, 2021 | |
SEGMENT INFORMATION | |
SEGMENT INFORMATION | NOTE 25 - SEGMENT INFORMATION: The Chief Executive Officer is the Company’s Chief Operating Decision Maker (“CODM”). The CODM allocates resources and assesses the Company’s performance based on the following segmentation: Effective December 31, 2021, the Company changed its operating segments to reflect the manner in which the Company's CODM The CODM does not review assets by operating segment. ® a. Segment information 1) Revenues 2) Adjusted EBITDA by segment: The following table presents segment profitability and a reconciliation to the consolidated net loss and comprehensive loss for the periods indicated: Year Ended December 31, 2021 2020 2019 U.S. dollars in thousands Commercial Operations Segment Adjusted EBITDA (15,527) (27,236) (15,913) Research And Development Adjusted EBITDA (37,247) (23,501) (23,048) Financial expenses (income), net 16,609 12,489 (897) Share-based compensation to employees and service providers 10,212 4,202 3,027 Depreciation 1,914 1,710 997 Amortization and impairment of intangible assets 16,235 7,035 216 Consolidated Comprehensive loss (97,744) (76,173) (42,304) b. Major customers The following table represent the percentages of total net revenues from the major customers: Year Ended December 31, 2021 2020 2019 Customer A 32% 35% Customer B 31% 28% Customer C 32% 35% 10% Customer D 45% Customer E 18% The Company’s revenues were entirely in the U.S. and the payment terms for all customers are 30 to 60 days. c. Segment assets The Company’s non-current assets located in Israel as of December 31, 2021, amount to $7 |
LOSS PER ORDINARY SHARE
LOSS PER ORDINARY SHARE | 12 Months Ended |
Dec. 31, 2021 | |
LOSS PER ORDINARY SHARE | |
LOSS PER ORDINARY SHARE | NOTE 26 - LOSS PER ORDINARY SHARE: a. Basic The basic loss per share is calculated by dividing the loss by the weighted average number of ordinary shares in issue during the period. The following is data taken into account in the computation of basic loss per share: Year Ended December 31, 2021 2020 2019 Loss (U.S. dollars in thousands) 97,744 76,173 42,304 Weighted average number of ordinary shares outstanding during the period (in thousands) 465,273 364,276 296,922 Basic loss per share (U.S. dollars) 0.21 0.21 0.14 b. Diluted Diluted loss per share is calculated by adjusting the weighted average number of ordinary shares outstanding, assuming conversion of all potentially dilutive ordinary shares, using the treasury stock method. The Company had two categories of potentially dilutive ordinary shares: warrants issued to investors and options issued to employees and service providers. The effect of these options and warrants for all reporting years is anti-dilutive. |
RELATED PARTIES
RELATED PARTIES | 12 Months Ended |
Dec. 31, 2021 | |
RELATED PARTIES | |
RELATED PARTIES | NOTE 27 - RELATED PARTIES: a. Key management in 2021 includes members of the Board of Directors, including the Company’s Chief Commercial Officer and Chief Executive Officer: Year Ended December 31, 2021 2020 2019 U.S. dollars in thousands Key management compensation: Salaries and other short-term employee benefits 1,668 1,526 876 Post-employment benefits 91 61 43 Share-based payments 1,611 661 468 Other long-term benefits 54 33 26 b. Balances with related parties: December 31, 2021 2020 U.S. dollars in thousand Current liabilities - Credit balance in “accrued expenses and other current liabilities” 399 484 |
EVENTS SUBSEQUENT TO DECEMBER 3
EVENTS SUBSEQUENT TO DECEMBER 31, 2021 | 12 Months Ended |
Dec. 31, 2021 | |
EVENT SUBSEQUENT TO DECEMBER 31, 2021 | |
EVENTS SUBSEQUENT TO DECEMBER 31, 2021 | NOTE 28 - EVENTS SUBSEQUENT TO DECEMBER 31, 2021: a. On January 20, 2022, the Company's BoD approved a grant of 1,920,500 Restricted Stock Units (“RSUs”), each one equal to one ADS of the Company, to officers, employees, and consultants of the Company and of RedHill Inc. and 140,000 RSUs to the Company's directors and Chief Executive Officer (subject to an approval by the Annual General Meeting of the Company's shareholders), under the Company’s 2010 Award Plan. The estimated fair value of the RSUs as of the date of BoD approval date was $6 million. b. In October 2021, the Company entered into an exclusive license agreement (the “License Agreement”) with Gaelan Medical Trade LLC ("Gaelan") for Talicia® in the United Arab Emirates (UAE). Under the terms of the License Agreement, the Company will receive an upfront payment of $2 million. In addition, the Company is eligible for additional milestone payments as well as tiered royalties up to mid-teens on net sales of Talicia in the UAE. Gaelan will receive the exclusive rights to commercialize Talicia® in the UAE, as well as a right of first refusal to commercialize Talicia® in the Gulf Cooperation Council region (Saudi Arabia, Kuwait, Qatar, Bahrain and Oman) for a pre-determined period. Gaelan shall be responsible for obtaining and maintaining regulatory approvals, as well as to conduct any and all required clinical and other studies. In addition, upon receipt of necessary regulatory approvals, Gaelan is to become “Medical Authorization Holder” in the UAE. In connection with the License Agreement, the Company and Gaelan entered into a supply agreement, according to which, the Company will exclusively manufacture (by a third party CMO) and supply to Gaelan during the term of the agreement. c. In March 2022 The company entered into an exclusive license agreement with Kukbo for oral opaganib for the treatment of COVID-19, in South Korea. Under the terms of the license agreement, which follows the strategic investment by Kukbo noted in note in note 18(c) above, RedHill will receive an upfront payment of $1.5 million and is eligible for up to $5.6 million in milestone payments as well as low double-digit royalties on net sales of oral opaganib in South Korea. Kukbo will receive the exclusive rights to commercialize opaganib in South Korea for COVID-19. d. During February and March 2022, the Company sold 282,626 ADSs under the ATM program at an average price of $2.2 per ADS for aggregate net proceeds of approximately $0.6 million, net of an immaterial amount of issuance expenses. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Basis for presentation of the financial statements | a. Basis for presentation of the financial statements The consolidated financial statements of the Company have been prepared in accordance with International Financial Reporting Standards (“IFRS”), as issued by the International Accounting Standards Board (“IASB”). The significant accounting policies described below have been applied consistently in relation to all the periods presented, unless otherwise stated. The consolidated financial statements have been prepared under the historical cost convention, subject to adjustments in respect of revaluation of financial assets and financial liabilities at fair value through profit or loss. The preparation of financial statements in conformity with IFRS requires the use of certain critical accounting estimates. It also requires management to exercise its judgment in applying the Company’s accounting policies. The areas involving a higher degree of judgment or complexity, or areas where assumptions and estimates are significant to the financial statements, are disclosed in note 3. Actual results could differ significantly from those estimates and assumptions. |
Translation of foreign currency transactions and balances | b. Translation of foreign currency transactions and balances 1) Functional and presentation currency Items included in the consolidated financial statements are measured using the currency of the primary economic environment in which the Company and its subsidiary operate (the “Functional Currency”). The consolidated financial statements are presented in U.S. dollars (“$”), which is the Company’s functional and presentation currency. 2) Transactions and balances Foreign currency transactions in currencies different from the Functional Currency (hereafter foreign currency, mostly New Israeli Shekel (“NIS”) and Euro are translated into the Functional Currency using the exchange rates at the dates of the transactions. Foreign exchange differences resulting from the settlement of such transactions and from the translation of period-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recorded in the Statements of Comprehensive Loss under financial income or financial expenses. |
Principles of consolidation | c. Principles of consolidation The Company’s consolidated financial statements include the accounts of the Company and its subsidiary. All intercompany balances and transactions have been eliminated in consolidation. |
Cash and cash equivalents | d. Cash and cash equivalents Cash and cash equivalents include cash on hand and unrestricted short-term bank deposits with maturities of three months or less. |
Trade receivables | e. Trade receivables Trade receivables are recognized initially at the amount of consideration that is unconditional. They are subsequently measured at amortized cost using the effective interest method, less expected loss allowance. See also note (i)(3). |
Inventory | f. Inventory The Company’s inventory represents items purchased by the Company and held for sale in the ordinary course of business, as well as inventory in the process of production for a sale in the ordinary course of business or materials or supplies to be used in the production process, to the extent they are recoverable. The inventory is stated at the lower of cost or net realizable value. Cost of inventory is determined using the first-in, first-out method. The Company continually evaluates inventory for potential loss due to excess quantity or obsolete or slow-moving inventory by comparing sales history and sales projections to the inventory on hand. When evidence indicates that the carrying value of a product may not be recoverable, a charge is recorded to reduce the inventory to its current net realizable value. |
Fixed assets | g. Fixed assets Fixed assets items are stated at cost less accumulated depreciation. Depreciation is computed by the straight-line method, to reduce the cost of fixed assets to their residual value over their estimated useful lives as follows: % Computer equipment 33 Office furniture and equipment 8-15 Leasehold improvements are depreciated by the straight-line method over the shorter of the term of the lease or the estimated useful life of the improvements. |
Intangible assets | h. Intangible assets 1) Licenses The Company’s intangible assets represent in-licenses of development-phase compounds acquired by the Company, where the Company continues or has the option to continue to do the development work (“R&D assets”), as well as commercialization rights Commercialization R&D assets that are available for use are stated at cost and amortized on a straight-line basis over their useful life from the time they are available for use. R&D assets that are not available for use are tested for impairment at least annually. Commercialization In determining the useful life of a commercialization Amounts due for future payment based on contractual agreements are accrued upon reaching the relevant milestones. All intangible assets are tested for impairment if any events have occurred or changes in circumstances have taken place which might indicate that their carrying amounts may not be recoverable. See also note 3 for key assumptions used in the determination of the recoverable amounts. An impairment loss is recognized for the amount by which the asset’s carrying amount exceeds its recoverable amount. The recoverable amount is the higher of an asset’s fair value less costs to sell and value in use. For purposes of assessing impairment, assets are grouped at the lowest levels for which there are separately identifiable cash flows (cash-generating units). 2) Research and development Research expenses are recognized as an expense as incurred. An intangible asset arising from the development of the Company’s therapeutic candidates is recognized if all of the following conditions are met: ● it is technically feasible to complete the intangible asset so that it will be available for use; ● management intends to complete the intangible asset and use it or sell it; ● there is an ability to use or sell the intangible asset; ● it can be demonstrated how the intangible asset will generate probable future economic benefits; and ● adequate technical, financial and other resources to complete the development and to use or sell the intangible asset are available and costs associated with the intangible asset during development can be measured reliably. Other development costs that do not meet the above criteria are recognized as expenses as incurred. Development costs previously recognized as an expense are not recognized as an asset in a subsequent period. Research and development costs for the performance of pre-clinical trials, clinical trials, and manufacturing by subcontractors are recognized as expenses when incurred. |
Research and development | 2) Research and development Research expenses are recognized as an expense as incurred. An intangible asset arising from the development of the Company’s therapeutic candidates is recognized if all of the following conditions are met: ● it is technically feasible to complete the intangible asset so that it will be available for use; ● management intends to complete the intangible asset and use it or sell it; ● there is an ability to use or sell the intangible asset; ● it can be demonstrated how the intangible asset will generate probable future economic benefits; and ● adequate technical, financial and other resources to complete the development and to use or sell the intangible asset are available and costs associated with the intangible asset during development can be measured reliably. Other development costs that do not meet the above criteria are recognized as expenses as incurred. Development costs previously recognized as an expense are not recognized as an asset in a subsequent period. Research and development costs for the performance of pre-clinical trials, clinical trials, and manufacturing by subcontractors are recognized as expenses when incurred. |
Financial assets | i. Financial assets 1) Classification The financial assets of the Company are classified into the following categories: financial assets at fair value through profit or loss, and financial assets at amortized cost. The classification is done on the basis of the Company’s business model for managing the financial asset and the contractual cash flow characteristics of the financial asset. a) Financial assets at amortized cost are assets held within a business model whose objective is to hold assets in order to collect contractual cash flows and the contractual terms of the financial asset give rise on specified dates to cash flows that are solely payments of principal and interest on the principal amount outstanding . Financial assets at amortized cost are included in current assets, except for those with maturities greater than 12 months after the Statements of Financial Position date (for which they are classified as noncurrent assets). Financial assets at amortized cost of the Company are included in trade receivables, and other receivables and bank deposits in the Statements of Financial Position. b) Financial assets at fair value through profit or loss of the Company are assets not measured at amortized cost in accordance with (1)(a) above. Assets in this category are classified as current assets if they are expected to be settled within 12 months; otherwise, they are classified as noncurrent. 2) Regular purchases and sales of financial assets are recognized on the settlement date, which is the date on which the asset is delivered to the Company or delivered by the Company. Investments are initially recognized at fair value plus direct incremental transaction costs for all financial assets not recorded at fair value through profit or loss, except for trade receivables, that are recognized initially at the amount of consideration that is unconditional. Financial assets measured at fair value through profit or loss are initially recognized at fair value, related transaction costs are expensed to profit or loss. Financial assets are derecognized when the rights to receive cash flows from the investments have expired or have been transferred and the Company has transferred substantially all risks and rewards of ownership. Financial assets at fair value through profit or loss are subsequently recorded at fair value. Financial assets at amortized cost are measured in subsequent periods at amortized cost using the effective interest method. Gains or losses arising from changes in the fair value of financial assets at fair value through profit or loss are presented in the Statements of Comprehensive Loss under “Financial Expenses (Income), net.” 3) The Company recognizes a loss allowance for expected credit losses on financial assets at amortized cost. At each reporting date, the Company assesses whether the credit risk on a financial instrument has increased significantly since initial recognition. If the financial instrument is determined to have a low credit risk at the reporting date, the Company assumes that the credit risk on a financial instrument has not increased significantly since initial recognition. The Company measures the loss allowance for expected credit losses on trade receivables that are within the scope of IFRS 15 and on financial instruments for which the credit risk has increased significantly since initial recognition based on lifetime expected credit losses. Otherwise, the Company measures the loss allowance at an amount equal to 12-month expected credit losses at the current reporting date. |
Financial liabilities | j. Financial liabilities Financial liabilities are initially recognized at their fair value minus transaction costs that are directly attributable to the issue of the financial liability and are subsequently measured at amortized cost. The Company’s financial liabilities at amortized cost include: accounts payable, accrued expenses and other current liabilities, lease liabilities, borrowing, payable in respect of the intangible asset and royalty obligation. |
Share capital | k. Share capital The Company ’ |
Employee benefits | l. Employee benefits 1) Pension and retirement benefit obligations In any matter related to payment of pension and severance pay to employees in Israel to be dismissed or to retire from the Company, the Company operates in accordance with labor laws. Labor laws and agreements in Israel, as well as the Company’s practice, require the Company to pay severance pay and/or pensions to employees dismissed or retired, in certain circumstances. The Company has a severance pay plan in accordance with Section 14 of the Israeli Severance Pay Law which is treated as a defined contribution plan. According to the plan, the Company regularly makes payments to severance pay or pension funds without having a legal or constructive obligation to pay further contributions if the fund does not hold sufficient assets to pay the related payments to employees’ service in current and prior periods. Contributions for severance pay or pension are recognized as employee benefit expenses when they are due commensurate with receipt of work services from the employee, and no further provision is required in the financial statements. The Company’s subsidiary provides, at will, benefit contributions for its employees. 2) Vacation and recreation pay Under Israeli law, each employee in Israel is entitled to vacation days and recreation pay, both computed on an annual basis. This entitlement is based on the period of employment. The Company records expenses and liability for vacation and recreation pay based on the benefit accumulated by each employee. |
Share-based payments | m. Share-based payments The Company operates several equity-settled, share-based compensation plans to employees (as defined in IFRS 2 “Share-Based Payments”) and service providers. As part of the plans, the Company grants employees and service providers, from time to time and at its discretion, options to purchase Company shares. The fair value of the employee and service provider services received in exchange for the grant of the options is recognized as an expense in profit or loss and is recorded as accumulated deficit within equity. For employees, the total amount recognized as an expense over the vesting period of the options (the period during which all vesting conditions are expected to be met) is determined by reference to the fair value of the options granted at the date of grant. For service providers (including equity instruments granted in consideration for intangible assets, see note 16(4), the Company measures the awards based on the fair value of the asset or service received. Vesting conditions are included in the assumptions about the number of options that are expected to vest. The total expense is recognized over the vesting period, which is the period over which all of the specified vesting conditions are to be satisfied. At the end of each reporting period, the Company revises its estimates of the number of options that are expected to vest based on non-market vesting conditions. The Company recognizes the impact of the revision to original estimates, if any, in profit or loss, with a corresponding adjustment to accumulated deficit. When exercising options, the Company issues new shares. The proceeds, less directly attributable transaction costs, are recognized as share capital (par value) and share premium. |
Revenue from contracts with customers | n. Revenue from contracts with customers The Company generated revenue in the years presented in these financial statements from product sales, including in-licensed products, and from promotional services provided in relation to third-party products. 1) Revenue from the sale of products The Company sells products mainly to wholesale distributors. Revenue is recognized at a point in time when control over the product is transferred to the customer (upon delivery), at the net selling price, which reflects reserves for variable consideration, including discounts and allowances. The transaction price in these arrangements is the consideration to which the Company expects to be entitled from the customer. The consideration promised in a contract with the Company’s customers may include fixed amounts and variable amounts. The Company estimates the variable consideration and includes it in the transaction price using the most likely outcome method, and only to the extent it is highly probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The specific considerations the Company uses in estimating these amounts related to variable consideration are as follows: Trade discounts and distribution fees Rebates and patient discount programs. Product returns. Principal versus agent considerations 2) Revenue from promotional services In 2020, the Company terminated the promotional agreements and recognized immaterial revenues from promotional services. In 2019 the Company recognized revenue from promotional services as it satisfied its performance obligation over time, in an amount equal to the consideration to which it expected to be entitled to, taking into consideration the constraint on variable considerations stipulated in IFRS 15. 3) Practical expedients and exemptions The Company expenses sales commissions when incurred since the amortization period of the asset that the Company otherwise would have recognized would have been for less than one year. These costs are recorded as selling and marketing expenses. |
Advertising and promotional expenses | o. Advertising and promotional expenses Advertising and promotional costs include, among others, distribution of free |
Loss per ordinary share | p. Loss per ordinary share The computation of basic loss per share is based on the Company’s loss divided by the weighted average number of ordinary shares outstanding during the period. In calculating the diluted loss per share, the Company adds the weighted average of the number of shares to be issued to the average number of shares outstanding used to calculate the basic loss per share, assuming all shares that have a potentially dilutive effect have been exercised into shares. |
Deferred taxes | q. Deferred taxes Deferred income tax is recognized using the liability method for temporary differences arising between the tax bases of assets and liabilities and their carrying amounts in these financial statements. Deferred income tax is determined using tax rates (and laws) that have been enacted or substantially enacted by the date of the Statements of Financial Position and are expected to apply when the related deferred income tax asset will be realized, or the deferred income tax liability will be settled. Deferred income tax assets are recognized only to the extent that it is probable that future taxable profit will be available against which the temporary differences can be utilized. Since the Company is unable to assess whether it will have taxable income in the foreseeable future, no deferred tax assets were recorded in these financial statements. |
Leases | r. Leases From January 1, 2019, the leases are recognized as a right-of-use asset and a corresponding liability at the date at which the leased asset is available for use by the Company. Each lease payment is allocated between the liability and finance cost. The finance cost is charged to profit or loss over the lease period so as to produce a constant periodic rate of interest on the remaining balance of the liability for each period. The right-of-use asset is depreciated over the shorter of the asset’s useful life and the lease term on a straight-line basis. Assets and liabilities arising from a lease are initially measured on a present value basis. Lease liabilities include the net present value of the following lease payments: fixed payments (including in-substance fixed payments) and variable lease payments that are based on an index or a rate. The lease payments are discounted using the lessee’s incremental borrowing rate, being the rate that the lessee would have to pay to borrow the funds necessary to obtain an asset of similar value in a similar economic environment with similar terms and conditions. Right-of-use assets are measured at cost being the amount of the initial measurement of the lease liability. Payments associated with short-term leases and leases of low-value assets are not recognized as right-of-use assets or lease liabilities but are recognized on a straight-line basis as an expense in profit or loss. Short-term leases are leases with a lease term of 12 months or less. Low-value assets include IT-equipment and small items of office furniture. Contracts may contain both lease and non-lease components. For leases of properties, the Company allocates the consideration in the contract to the lease and non-lease components based on their relative stand-alone prices. However, for leases of vehicles, for which the Company is a lessee, it has elected not to separate lease and non-lease components and instead accounts for these as a single lease component. |
Recently issued accounting pronouncements | s. Recently issued accounting pronouncements: 1) Amendments to IAS 1 regarding classifying liabilities as current or non-current In January 2020, the IASB issued amendment to IAS 1 to specify the requirements for classifying liabilities as current or non-current. The amendments clarify: the definition of a right to defer a settlement, that a right to defer must exist at the end of the reporting period, that classification is unaffected by the likelihood that an entity will exercise its deferral right, that only if an embedded derivative in a convertible liability is itself an equity instrument would the terms of a liability not impact its classification. The amendment is effective for annual periods beginning on or after January 1, 2023. At this stage the Company cannot evaluate the effect of the amendment on the financial statements. 2) Amendments to IFRS 9, IFRS 7, IFRS 16, IFRS 4 and IAS 39 regarding the IBOR reform In August 2020, the IASB issued amendments to IFRS 9, “Financial Instruments”, IFRS 7, “Financial Instruments: Disclosures”, IAS 39, “Financial Instruments: Recognition and Measurement”, IFRS 4, “Insurance Contracts”, and IFRS 16, “Leases” (“IBOR Amendments”). The IBOR Amendments provide practical expedients when accounting for the effects of the replacement of benchmark InterBank Offered Rates (IBORs) by alternative Risk-Free Interest Rates (RFRs). Pursuant to one of the practical expedients, an entity will treat contractual changes or changes to cash flows that are directly required by the reform as changes to a floating interest rate. That is, an entity recognizes the changes in interest rates as an adjustment of the effective interest rate without adjusting the carrying amount of the financial instrument. The use of this practical expedient is subject to the condition that the transition from IBOR to RFR takes place on an economically equivalent basis. The IBOR Amendments include new disclosure requirements in connection with the expected effect of the reform on an entity’s financial statements, such as how the entity is managing the process to transition to the interest rate reform, the risks to which it is exposed due to the reform and quantitative information about IBOR-referenced financial instruments that are expected to change. The IBOR Amendments are effective for annual periods beginning on or after January 1, 2021. The IBOR Amendments are to be applied retrospectively. However, restatement of comparative periods is not required. Early application is permitted. The Company adopted the IBOR amendments as from January 1, 2021. The adoption of the IBOR Amendment does not have an effect on the Company’s financial statements. |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Schedule of estimated useful lives of fixed assets | % Computer equipment 33 Office furniture and equipment 8-15 |
FINANCIAL INSTRUMENTS AND FIN_2
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT | |
Schedule of company's financial liabilities and estimated maturities | Contractual maturities of financial liabilities At 31 December 2021 Less than 1 year 2-5 years More than 5 years Total contractual cash flows Carrying amount U.S. Dollars in Thousands Accounts payable 11,664 11,664 11,664 Lease liabilities 2,109 2,553 4,662 4,192 Accrued expenses and other current liabilities 20,896 20,896 20,896 Borrowing 9,159 107,213 9,000 125,371 83,620 Payable in respect of intangible assets purchase 17,600 5,000 22,600 20,480 Royalty obligation - 1,011 1,351 2,362 750 Contractual maturities of financial liabilities At 31 December 2020 Less than 1 year 2-5 years More than 5 years Total contractual cash flows Carrying amount U.S. Dollars in Thousands Accounts payable 11,553 11,553 11,553 Lease liabilities 1,985 4,210 — 6,195 5,517 Accrued expenses and other current liabilities 24,082 24,082 24,082 Borrowing 10,154 107,514 18,530 136,198 81,386 Payable in respect of intangible assets purchase 20,600 10,000 30,600 24,745 Royalty obligation 127 747 912 1,786 750 |
CASH AND CASH EQUIVALENTS (Tabl
CASH AND CASH EQUIVALENTS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
CASH AND CASH EQUIVALENTS. | |
Schedule of cash and cash equivalents | December 31, 2021 2020 U.S. dollars in thousands Cash in bank 28,890 14,265 Short-term bank deposits 584 15,030 29,474 29,295 |
PREPAID EXPENSES AND OTHER RE_2
PREPAID EXPENSES AND OTHER RECEIVABLES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
PREPAID EXPENSES AND OTHER RECEIVABLES | |
Schedule of prepaid expenses and other receivables | December 31, 2021 2020 U.S. dollars in thousands Advance to suppliers 632 2,543 Government institutions 847 634 Prepaid expenses and others 3,182 2,344 4,661 5,521 |
INVENTORY (Tables)
INVENTORY (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
INVENTORY | |
Schedule of Inventory | December 31, 2021 2020 U.S. dollars in thousands Raw materials 3,012 1,792 Work in progress 5,195 — Finished goods 6,603 4,734 14,810 6,526 |
FIXED ASSETS (Tables)
FIXED ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
FIXED ASSETS | |
Schedule of composition of assets and accumulated depreciation, grouped by major classifications | Cost Accumulated depreciation Depreciated balance December 31 December 31 December 31 2021 2020 2021 2020 2021 2020 U.S. dollars in thousands Office furniture and equipment (including computers) 1,024 753 677 479 347 274 Leasehold improvements 357 357 132 120 225 237 1,381 1,110 809 599 572 511 |
LEASES (Tables)
LEASES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
GENERAL | |
Schedule of amounts recognized for leases | Year Ended December 31, 2021 2020 U.S dollars in thousands Right-of-use assets: Properties 1,986 2,593 Vehicles 1,665 2,599 3,651 5,192 Lease liabilities: Current 1,618 1,710 Non-current 2,574 3,807 4,192 5,517 Additions to the right-of-use assets and lease liabilities during the years ended 2021 2020 Amounts recognized in the consolidated statements of comprehensive loss: Year Ended December 31, 2021 2020 Depreciation charge of right-of-use assets Properties 608 607 Vehicles 1,282 948 1,890 1,555 Interest expense (included in financial expenses) 397 574 Expenses relating to short-term leases and leases of low-value assets are immaterial. The total cash outflow for leases in 2021 and 2020 was $1.9 million and $2 million respectively. |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
INTANGIBLE ASSETS | |
Schedule of intangible assets changes | Year Ended December 31, 2021 2020 U.S. dollars in thousands R&D assets: Cost: Balance at beginning of year 5,757 5,355 Additions during the year — 402 Balance at end of year 5,757 5,757 Accumulated amortization: Balance at beginning of year (50) — Amortization charges (66) (50) Balance at end of year (116) (50) 5,641 5,707 Commercialization assets: Cost: Balance at beginning of year 89,373 11,788 Additions during the year see notes 16(4) - 16(6) — 77,585 Balance at end of year 89,373 89,373 Accumulated impairments and amortization: Balance at beginning of year (7,201) (216) Amortization and impairment charges see (b) below (16,169) (6,985) Balance at end of year (23,370) (7,201) 66,003 82,172 71,644 87,879 |
ACCRUED EXPENSES AND OTHER CU_2
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | |
Schedule of accrued expenses and other current liabilities | December 31, 2021 2020 U.S. dollars in thousands Accrued expenses 17,234 18,972 Employees and related liabilities 3,496 4,963 Government institutions 167 147 20,896 24,082 |
ALLOWANCE FOR DEDUCTIONS FROM_2
ALLOWANCE FOR DEDUCTIONS FROM REVENUES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
ALLOWANCE FOR DEDUCTIONS FROM REVENUES | |
Schedule of movement of allowance for deductions from revenue | Rebates and patient discount programs Product returns Total U.S. dollars in thousands As of January 1, 2021 16,380 1,963 18,343 Increases 94,640 851 95,491 Decreases (utilized) (80,633) (2,179) (82,812) Adjustments (645) 334 (311) As of December 31, 2021 29,742 969 30,711 Rebates and patient discount programs Product returns Total U.S. dollars in thousands As of January 1, 2020 1,001 266 1,267 Increases 56,669 2,469 59,138 Decreases (utilized) (40,656) (772) (41,428) Adjustments (634) - (634) As of December 31, 2020 16,380 1,963 18,343 Rebates and patient discount programs Product returns Total U.S. dollars in thousands As of January 1, 2019 573 385 958 Increases 2,485 303 2,788 Decreases (utilized) (2,057) (72) (2,129) Adjustments - (350) (350) As of December 31, 2019 1,001 266 1,267 |
BORROWING (Tables)
BORROWING (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
BORROWING. | |
Schedule of reconciliation of liabilities arising from financing activities | Non-cash changes U.S. dollars in thousands January 1, 2021 Proceeds from borrowings Principal and interest payments Addition during the year Interest expense Foreign exchange movement December 31, 2021 Borrowing $81,386 ($9,701) $11,935 $83,620 Payable in respect of intangible assets purchase $24,746 ($8,500) $4,234 $20,480 Lease liabilities $5,517 ($2,107) $385 355 42 $4,192 Non-cash changes January 1, 2020 Proceeds from borrowings Principal and interest payments Addition during the year Interest expense Foreign exchange movement December 31, 2020 Borrowing - $78,061 ($6,246) $9,571 $81,386 Payable in respect of intangible assets purchase - $22,288 $2,458 $24,746 Lease liabilities $3,815 ($1,802) $2,930 $406 $168 $5,517 Non-cash changes January 1, 2019 Proceeds from borrowings Principal and interest payments Addition during the year Interest expense Foreign exchange movement December 31, 2019 Lease liabilities $1,667 ($1,047) $2,805 $251 $139 $3,815 |
SHARE CAPITAL (Tables)
SHARE CAPITAL (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
SHARE CAPITAL | |
Schedule of composition of share capital | Number of shares December 31, 2021 2020 In thousands Authorized ordinary shares 794,000 794,000 Authorized preferred shares (reserved) 6,000 6,000 Issued and paid ordinary shares 524,016 383,981 |
SHARE-BASED PAYMENTS (Tables)
SHARE-BASED PAYMENTS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
SHARE-BASED PAYMENTS | |
Schedule of information on options granted | a. The following is information on options granted in 2021: Number of options granted According to the Award Plan Exercise Fair value of of the Company price for 1 options on date of Other than to ADS ($) grant in U.S. dollars Date of Grant directors (1) To directors (1)(2) Total in thousands (1)(2)(3) March 2021 40,500 — 40,500 9.44 151 April 2021 2,036,440 — 2,036,440 7.08 8,274 May 2021 22,500 — 22,500 7.05 90 July 2021 17,000 310,341 327,341 6.9-7.08 1,377 August 2021 53,500 53,500 6.97-7.18 210 September 2021 12,000 — 12,000 4.56 31 November 2021 24,500 — 24,500 4.54 63 December 2021 17,000 — 17,000 2.65 26 2,223,440 310,341 2,533,781 10,221 1) The options will vest as follows: for directors, employees and consultants of the Company and the Company's subsidiary who had provided services exceeding one year as of the grant date, options will vest in 16 equal quarterly installments over a four-year period. For directors, employees and consultants of the Company and the Company's subsidiary who had not provided services exceeding one year as of the grant date, the options will vest as follows: 1/4 The options are exercisable into the Company’s ADSs. 2) The general meeting of the Company’s shareholders held on July 26 1 3) The fair value of the options was computed using the binomial model and the underlying data used was mainly the following: price of the Company’s ADSs: $4.28 - $9.19, expected volatility: 64.05% - 66.65 %, risk-free interest rate: 1.26% 4) Exchange of options to purchase the Company’s ADSs: a. On April 26, 2021, the Company made an o ffer ( the “Exchange Offer”) to eligible option holders (as defined in the offer), subject to specified conditions, to exchange some or all of their outstanding options to purchase ADSs ( the “Exchanged Options”) for new options to purchase ADSs ( the “New Options” ). On May 26, 2021, concurrently with the expiration of the Exchange Offer, the Company granted New Options to purchase 2,805,281 ADSs of the Company, pursuant to the terms of the Exchange Offer and the Company’s Amended and Restated Award Plan (2010). The New Options have lower exercise price per ADS than the Exchanged Options and subject to meeting certain performance conditions, specified in the Exchange Offer, may be further lowered. Other than the exercise price, each New Option has the same expiration date, vesting schedule and other terms as the Exchanged Options . b. The incremental compensation expense recognized by the Company has been measured as the excess of the fair value of each New Option granted, as of the date the New Options were granted, over the fair value of the Exchanged Options, measured immediately prior to the exchange. The total incremental value measured by the Company is approximately $3.5 million, of which $3.3 million was recognized as an expense for the year ended December 31, 2021. The remaining incremental value will be recognized over the remaining vesting period of the New Options. c. b. The following is information on options granted in 2020: Number of options granted According to the Award Plan Exercise Fair value of of the Company price for 1 options on date of Other than to Ads grant in U.S. dollars Date of BoD directors (1) To directors (1) (2) Total ($) in thousands (3) January 2020 95,000 — 95,000 6.60 243 February 2020 52,500 — 52,500 6.05 119 March 2020 285,000 — 285,000 4.87 683 May 2020 143,000 219,000 362,000 7.50 1,118 June 2020 767,500 — 767,500 7.72 2,671 July 2020 12,500 — 12,500 7.69 45 August 2020 55,500 — 55,500 8.72 264 November 2020 21,000 — 21,000 10.20 90 1,432,000 219,000 1,651,000 5,233 1) The options vesting terms are as described in note 19(a)(1) above. 2) The general meeting of the Company’s shareholders held on May 4, 2020, subsequent to approval of the Company’s BoD, approved the grant of 219,000 options under the Company’s Award Plan, to directors and to the Company's Chief Executive Officer. 3) The fair value of the options was computed using the binomial model and the underlying data used was mainly the following: price of the Company’s ADSs: $4.28 - $9.19, expected volatility: 57.73% - 63.63%, risk-free interest rate: 0.64% - 1.51% and the expected term was derived based on the contractual term of the options, the expected exercise behavior and expected post-vesting forfeiture rates. the expected volatility assumption used in based on the historical volatility of the Company’s ordinary share. |
Schedule of number of shares and weighted averages of exercise prices | Year Ended December 31, 2021 2020 Weighted Weighted average of average of Number of exercise Number of exercise options price ($) options price ($) Outstanding at beginning of year 5,428,803 9.08 4,050,898 10.30 Exercised (565,998) 7.08 (8,156) 6.38 Expired and forfeited (575,095) 8.02 (264,939) 9.65 Granted 2,533,781 7.05 1,651,000 6.90 Outstanding at end of year 6,821,491 6.50 5,428,803 9.08 Exercisable at end of year 3,615,662 6.14 3,178,317 10.19 |
Schedule of information about exercise price and remaining useful life of outstanding options | Year Ended December 31, 2021 2020 Number of Number of options Weighted options Weighted outstanding average of outstanding average of at end of Exercise price remaining at end of Exercise price remaining year range useful life year range useful life 6,821,491 $2.65-$15.6 6.8 5,428,803 $5.6-$16.1 5.9 |
Schedule of expenses recognized in profit or loss | Year Ended December 31, 2021 2020 2019 U.S. dollars in thousands 10,212 4,202 3,027 |
NET REVENUES (Tables)
NET REVENUES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
NET REVENUES | |
Schedule of net revenues | Year Ended December 31, 2021 2020 2019 U.S dollars in thousands Movantik® revenues 76,767 59,356 — Other products (1) 8,989 5,003 6,291 85,757 64,359 6,291 1) During 2019 $3.1 million were attributed to the promotional services, and $3.2 million, were attributed to commercialization of products. In 2020, the Company terminated the promotional agreements and recognized immaterial revenues from promotional services . |
RESEARCH AND DEVELOPMENT EXPE_2
RESEARCH AND DEVELOPMENT EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
RESEARCH AND DEVELOPMENT EXPENSES. | |
Schedule of research and development expenses | Year Ended December 31, 2021 2020 2019 U.S. dollars in thousands Payroll and related expenses 839 636 623 Professional services 1,821 1,752 2,345 Share-based payments 1,910 883 671 Clinical and pre-clinical trials 23,905 12,569 12,840 Intellectual property development 349 298 317 Other 674 353 623 29,498 16,491 17,419 |
SELLING AND MARKETING EXPENSES
SELLING AND MARKETING EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
SELLING AND MARKETING EXPENSES | |
Schedule of selling, marketing and business development expenses | Year Ended December 31, 2021 2020 2019 U.S. dollars in thousands Payroll and related expenses 24,227 20,756 9,335 Share-based payments 2,570 1,464 941 Professional services 17,441 18,957 3,680 Samples 1,008 438 178 Travel, Fleet, meals and related expenses 7,305 5,729 2,193 Office-related expenses 1,285 957 789 Other 1,787 984 1,217 55,623 49,285 18,333 |
GENERAL AND ADMINISTRATIVE EX_2
GENERAL AND ADMINISTRATIVE EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
GENERAL AND ADMINISTRATIVE EXPENSES | |
Schedule of general and administrative expenses | Year Ended December 31, 2021 2020 2019 U.S. dollars in thousands Payroll and related expenses 11,974 11,159 4,903 Share-based payments 5,732 1,855 1,415 Professional services 11,040 9,132 3,479 Medical affairs 1,600 1,052 299 Office-related expenses 1,438 1,168 585 Other 581 1,009 800 32,365 25,375 11,481 |
FINANCIAL EXPENSES (INCOME), _2
FINANCIAL EXPENSES (INCOME), net (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
FINANCIAL EXPENSES (INCOME), net | |
Schedule of financial income, net | Year Ended December 31, 2021 2020 2019 U.S dollars in thousands Financial income: Fair value gains on derivative financial instruments — — 344 Gains on financial assets at fair value through profit or loss — 94 474 Gains from changes in exchange rates — — 74 Interest from bank deposits 51 176 443 51 270 1,335 Financial expenses: Interest and finance charges for lease liabilities 395 405 390 Loss from changes in exchange rates 28 9 — Interest expenses related to borrowing and payable in respect of intangible assets purchase 16,172 12,045 — Other 65 300 48 16,660 12,759 438 Financial expenses (income), 16,609 12,489 (897) |
SEGMENT INFORMATION (Tables)
SEGMENT INFORMATION (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
SEGMENT INFORMATION | |
Schedule of segment profitability and reconciliation to consolidated net loss and comprehensive loss | Year Ended December 31, 2021 2020 2019 U.S. dollars in thousands Commercial Operations Segment Adjusted EBITDA (15,527) (27,236) (15,913) Research And Development Adjusted EBITDA (37,247) (23,501) (23,048) Financial expenses (income), net 16,609 12,489 (897) Share-based compensation to employees and service providers 10,212 4,202 3,027 Depreciation 1,914 1,710 997 Amortization and impairment of intangible assets 16,235 7,035 216 Consolidated Comprehensive loss (97,744) (76,173) (42,304) |
Schedule of percentages of total net revenues from major customers | Year Ended December 31, 2021 2020 2019 Customer A 32% 35% Customer B 31% 28% Customer C 32% 35% 10% Customer D 45% Customer E 18% |
LOSS PER ORDINARY SHARE (Tables
LOSS PER ORDINARY SHARE (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
LOSS PER ORDINARY SHARE | |
Schedule of basic loss per share | Year Ended December 31, 2021 2020 2019 Loss (U.S. dollars in thousands) 97,744 76,173 42,304 Weighted average number of ordinary shares outstanding during the period (in thousands) 465,273 364,276 296,922 Basic loss per share (U.S. dollars) 0.21 0.21 0.14 |
RELATED PARTIES (Tables)
RELATED PARTIES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
RELATED PARTIES | |
Schedule of key management compensation: | Year Ended December 31, 2021 2020 2019 U.S. dollars in thousands Key management compensation: Salaries and other short-term employee benefits 1,668 1,526 876 Post-employment benefits 91 61 43 Share-based payments 1,611 661 468 Other long-term benefits 54 33 26 |
Schedule of balances with related parties | December 31, 2021 2020 U.S. dollars in thousand Current liabilities - Credit balance in “accrued expenses and other current liabilities” 399 484 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) | 12 Months Ended |
Dec. 31, 2021 | |
Computer equipment | |
Accounting Policies [Line Items] | |
Depreciation rate (as a percent) | 33.00% |
Office furniture and equipment | Minimum | |
Accounting Policies [Line Items] | |
Depreciation rate (as a percent) | 8.00% |
Office furniture and equipment | Maximum | |
Accounting Policies [Line Items] | |
Depreciation rate (as a percent) | 15.00% |
CRITICAL ACCOUNTING ESTIMATES_2
CRITICAL ACCOUNTING ESTIMATES AND JUDGMENTS (Details) $ in Millions | 1 Months Ended | 12 Months Ended | ||
Apr. 30, 2020 | Oct. 31, 2019 | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | |
Aemcolo | ||||
Disclosure of significant unobservable inputs used in fair value measurement of assets [line items] | ||||
Impairment loss | $ 8.9 | $ 0.8 | ||
Useful life of assets (in years) | 11 years | |||
Movantik | ||||
Disclosure of significant unobservable inputs used in fair value measurement of assets [line items] | ||||
Useful life of assets (in years) | 10 years 6 months | 12 years 6 months | ||
Weighted average cost of capital | ||||
Disclosure of significant unobservable inputs used in fair value measurement of assets [line items] | ||||
Significant unobservable input | 0.16 |
FINANCIAL INSTRUMENTS AND FIN_3
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Financial instruments | |||
Percentage of currency stronger against the NIS | 5.00% | 5.00% | 5.00% |
Fair value of borrowing | $ 96 | $ 94 | |
Payable in respect of intangible assets purchase balances | $ 23 | $ 26 | |
Maximum | |||
Financial instruments | |||
Maturity periods for cash balances in highly-rated bank deposits | 1 year | ||
Portfolio invested in a single bond issuer (as a percent) | 10.00% | ||
Interest rate risk | Floating rate | Minimum | |||
Financial instruments | |||
Spread rate | 1.75% | ||
Interest rate risk | Fixed rate | |||
Financial instruments | |||
Borrowings, interest rate | 8.20% | ||
Interest rate risk | Fixed rate | Period for trailing four quarters ending March 31, 2021 | |||
Financial instruments | |||
Borrowings, interest rate | 6.70% |
FINANCIAL INSTRUMENTS AND FIN_4
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT - By contractual maturities (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Financial instruments | ||
Financial assets | $ 0 | |
Restricted cash | 16,169,000 | $ 16,164,000 |
Minimum | HCRM | ||
Financial instruments | ||
Restricted cash | 16,000,000 | 16,000,000 |
Accounts payable | ||
Financial instruments | ||
Financial liabilities | 11,664,000 | 11,553,000 |
Accounts payable | Cost | ||
Financial instruments | ||
Financial liabilities | 11,664,000 | 11,553,000 |
Accounts payable | Less than 1 year | ||
Financial instruments | ||
Financial liabilities | 11,664,000 | 11,553,000 |
Lease liabilities | ||
Financial instruments | ||
Financial liabilities | 4,662,000 | 6,195,000 |
Lease liabilities | Cost | ||
Financial instruments | ||
Financial liabilities | 4,192,000 | 5,517,000 |
Lease liabilities | Less than 1 year | ||
Financial instruments | ||
Financial liabilities | 2,109,000 | 1,985,000 |
Lease liabilities | 2-5 years | ||
Financial instruments | ||
Financial liabilities | 2,553,000 | 4,210,000 |
Accrued expenses and other current liabilities | ||
Financial instruments | ||
Financial liabilities | 20,896,000 | 24,082,000 |
Accrued expenses and other current liabilities | Cost | ||
Financial instruments | ||
Financial liabilities | 20,896,000 | 24,082,000 |
Accrued expenses and other current liabilities | Less than 1 year | ||
Financial instruments | ||
Financial liabilities | 20,896,000 | 24,082,000 |
Borrowing | ||
Financial instruments | ||
Financial liabilities | 125,371,000 | 136,198,000 |
Borrowing | Cost | ||
Financial instruments | ||
Financial liabilities | 83,620,000 | 81,386,000 |
Borrowing | Less than 1 year | ||
Financial instruments | ||
Financial liabilities | 9,159,000 | 10,154,000 |
Borrowing | 2-5 years | ||
Financial instruments | ||
Financial liabilities | 107,213,000 | 107,514,000 |
Borrowing | More than five years | ||
Financial instruments | ||
Financial liabilities | 9,000,000 | 18,530,000 |
Payable in respect of intangible assets purchase | ||
Financial instruments | ||
Financial liabilities | 22,600,000 | 30,600,000 |
Payable in respect of intangible assets purchase | Cost | ||
Financial instruments | ||
Financial liabilities | 20,480,000 | 24,745,000 |
Payable in respect of intangible assets purchase | Less than 1 year | ||
Financial instruments | ||
Financial liabilities | 17,600,000 | 20,600,000 |
Payable in respect of intangible assets purchase | 2-5 years | ||
Financial instruments | ||
Financial liabilities | 5,000,000 | 10,000,000 |
Royalty obligation | ||
Financial instruments | ||
Financial liabilities | 2,362,000 | 1,786,000 |
Royalty obligation | Cost | ||
Financial instruments | ||
Financial liabilities | 750,000 | 750,000 |
Royalty obligation | Less than 1 year | ||
Financial instruments | ||
Financial liabilities | 127,000 | |
Royalty obligation | 2-5 years | ||
Financial instruments | ||
Financial liabilities | 1,011,000 | 747,000 |
Royalty obligation | More than five years | ||
Financial instruments | ||
Financial liabilities | $ 1,351,000 | $ 912,000 |
CASH AND CASH EQUIVALENTS (Deta
CASH AND CASH EQUIVALENTS (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
CASH AND CASH EQUIVALENTS. | ||||
Cash in bank | $ 28,890 | $ 14,265 | ||
Short-term bank deposits | 584 | 15,030 | ||
Cash and cash equivalents | $ 29,474 | $ 29,295 | $ 29,023 | $ 29,005 |
FINANCIAL ASSETS AT FAIR VALU_2
FINANCIAL ASSETS AT FAIR VALUE THROUGH PROFIT OR LOSS (Details) | Dec. 31, 2021USD ($) |
FINANCIAL ASSETS AT FAIR VALUE THROUGH PROFIT OR LOSS. | |
Financial assets | $ 0 |
PREPAID EXPENSES AND OTHER RE_3
PREPAID EXPENSES AND OTHER RECEIVABLES (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
PREPAID EXPENSES AND OTHER RECEIVABLES | ||
Advance to suppliers | $ 632 | $ 2,543 |
Government institutions | 847 | 634 |
Prepaid expenses and others | 3,182 | 2,344 |
Total prepaid expenses and other receivables | $ 4,661 | $ 5,521 |
INVENTORY (Details)
INVENTORY (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
INVENTORY | ||
Raw materials | $ 3,012 | $ 1,792 |
Work in progress | 5,195 | |
Finished goods | 6,603 | 4,734 |
Total current inventories | 14,810 | 6,526 |
Inventories recognized as part of cost of revenues | 7,700 | 5,200 |
Inventories, at net realisable value | $ 300 | $ 400 |
FIXED ASSETS (Details)
FIXED ASSETS (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Fixed assets | ||
Accumulated depreciation | $ 809 | $ 599 |
Fixed assets | 572 | 511 |
Cost | ||
Fixed assets | ||
Fixed assets | 1,381 | 1,110 |
Office furniture and equipment (including computers) | ||
Fixed assets | ||
Accumulated depreciation | 677 | 479 |
Fixed assets | 347 | 274 |
Office furniture and equipment (including computers) | Cost | ||
Fixed assets | ||
Fixed assets | 1,024 | 753 |
Leasehold improvements | ||
Fixed assets | ||
Accumulated depreciation | 132 | 120 |
Fixed assets | 225 | 237 |
Leasehold improvements | Cost | ||
Fixed assets | ||
Fixed assets | $ 357 | $ 357 |
LEASES - Amounts Recognized (De
LEASES - Amounts Recognized (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Disclosure of quantitative information about right-of-use assets [line items] | ||
Right-of-use assets | $ 3,651 | $ 5,192 |
Additions to right-of-use assets | 400 | 2,900 |
Additions to lease liabilities | 400 | 2,900 |
Depreciation charge of right-of-use assets | 1,890 | 1,555 |
Interest expense (included in financial expenses) | 397 | 574 |
Cash outflow for leases | 1,900 | 2,000 |
Lease liabilities: | ||
Current | 1,618 | 1,710 |
Non-current | 2,574 | 3,807 |
Lease liabilities | 4,192 | 5,517 |
Properties | ||
Disclosure of quantitative information about right-of-use assets [line items] | ||
Right-of-use assets | 1,986 | 2,593 |
Depreciation charge of right-of-use assets | 608 | 607 |
Vehicles | ||
Disclosure of quantitative information about right-of-use assets [line items] | ||
Right-of-use assets | 1,665 | 2,599 |
Depreciation charge of right-of-use assets | $ 1,282 | $ 948 |
INTANGIBLE ASSETS - Changes in
INTANGIBLE ASSETS - Changes in Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Reconciliation of changes in intangible assets | |||
Balance at beginning of year | $ 87,879 | ||
Amortization and impairment charges | (16,235) | $ (7,035) | $ (216) |
Balance at end of year | 71,644 | 87,879 | |
R&D assets | |||
Reconciliation of changes in intangible assets | |||
Balance at beginning of year | 5,707 | ||
Balance at end of year | 5,641 | 5,707 | |
R&D assets | Cost | |||
Reconciliation of changes in intangible assets | |||
Balance at beginning of year | 5,757 | 5,355 | |
Additions during the year | 402 | ||
Balance at end of year | 5,757 | 5,757 | 5,355 |
R&D assets | Accumulated amortization | |||
Reconciliation of changes in intangible assets | |||
Balance at beginning of year | (50) | ||
Amortization charges | (66) | (50) | |
Balance at end of year | (116) | (50) | |
Commercialization assets | |||
Reconciliation of changes in intangible assets | |||
Balance at beginning of year | 82,172 | ||
Balance at end of year | 66,003 | 82,172 | |
Commercialization assets | Cost | |||
Reconciliation of changes in intangible assets | |||
Balance at beginning of year | 89,373 | 11,788 | |
Additions during the year | 77,585 | ||
Balance at end of year | 89,373 | 89,373 | 11,788 |
Commercialization assets | Accumulated impairments and amortization | |||
Reconciliation of changes in intangible assets | |||
Balance at beginning of year | (7,201) | (216) | |
Amortization and impairment charges | (16,169) | (6,985) | |
Balance at end of year | $ (23,370) | $ (7,201) | $ (216) |
INTANGIBLE ASSETS - Narrative (
INTANGIBLE ASSETS - Narrative (Details) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | |||
Apr. 30, 2020 | Nov. 30, 2019 | Oct. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | |
Movantik | |||||
Reconciliation of changes in intangible assets | |||||
Useful life of assets (in years) | 10 years 6 months | 12 years 6 months | |||
Aemcolo | |||||
Reconciliation of changes in intangible assets | |||||
Useful life of assets (in years) | 11 years | ||||
Impairment loss | $ 8.9 | $ 0.8 | |||
Talicia | |||||
Reconciliation of changes in intangible assets | |||||
Useful life of assets (in years) | 15 years |
LIABILITY FOR EMPLOYEE RIGHTS_2
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT | |||
Defined contribution plans expense | $ 285,000 | $ 214,000 | $ 184,000 |
ACCRUED EXPENSES AND OTHER CU_3
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | ||
Accrued expenses | $ 17,234 | $ 18,972 |
Employees and related liabilities | 3,496 | 4,963 |
Government institutions | 167 | 147 |
Accrued expenses and other current liabilities | $ 20,896 | $ 24,082 |
ALLOWANCE FOR DEDUCTIONS FROM_3
ALLOWANCE FOR DEDUCTIONS FROM REVENUES (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Disclosure of other provisions [line items] | |||
Balance at beginning of the period | $ 18,343 | $ 1,267 | $ 958 |
Increases | 95,491 | 59,138 | 2,788 |
Decreases (utilized) | (82,812) | (41,428) | (2,129) |
Adjustments | (311) | (634) | (350) |
Balance at end of the period | 30,711 | 18,343 | 1,267 |
Rebates and patient discount programs | |||
Disclosure of other provisions [line items] | |||
Balance at beginning of the period | 16,380 | 1,001 | 573 |
Increases | 94,640 | 56,669 | 2,485 |
Decreases (utilized) | (80,633) | (40,656) | (2,057) |
Adjustments | (645) | (634) | |
Balance at end of the period | 29,742 | 16,380 | 1,001 |
Product returns | |||
Disclosure of other provisions [line items] | |||
Balance at beginning of the period | 1,963 | 266 | 385 |
Increases | 851 | 2,469 | 303 |
Decreases (utilized) | (2,179) | (772) | (72) |
Adjustments | 334 | (350) | |
Balance at end of the period | $ 969 | $ 1,963 | $ 266 |
BORROWING (Details)
BORROWING (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Mar. 12, 2020 | Dec. 31, 2021 | Dec. 31, 2020 |
Disclosure of detailed information about borrowings [line items] | ||||
Restricted cash | $ 16,169 | $ 16,164 | ||
HCRM | ||||
Disclosure of detailed information about borrowings [line items] | ||||
Maturity term | 6 years | |||
Term, no principal payments required | 3 years | |||
Percentage of principal amount of term loan being repaid or prepaid | 4.00% | |||
HCRM | Period from January 1, 2021, to December 31, 2029 | ||||
Disclosure of detailed information about borrowings [line items] | ||||
Percentage of royalty income on net revenues | 4.00% | |||
HCRM | Period for trailing four quarters ending March 31, 2021 | ||||
Disclosure of detailed information about borrowings [line items] | ||||
Interest rate (as a percent) | 6.70% | |||
HCRM | Fixed rate | Period from January 1, 2021, to December 31, 2029 | ||||
Disclosure of detailed information about borrowings [line items] | ||||
Interest rate (as a percent) | 8.20% | |||
HCRM | Minimum | ||||
Disclosure of detailed information about borrowings [line items] | ||||
Restricted cash | $ 16,000 | $ 16,000 | ||
HCRM | Minimum | Period from January 1, 2021, to December 31, 2029 | ||||
Disclosure of detailed information about borrowings [line items] | ||||
Spread rate | 1.75% | |||
HCRM | Maximum | Period from January 1, 2021, to December 31, 2029 | ||||
Disclosure of detailed information about borrowings [line items] | ||||
Royalty income | $ 75,000 | |||
HCRM | Weighted average | ||||
Disclosure of detailed information about borrowings [line items] | ||||
Interest rate (as a percent) | 16.50% | |||
HCRM | Credit Agreement | ||||
Disclosure of detailed information about borrowings [line items] | ||||
Term loan received | $ 30,000 | |||
HCRM | Credit Agreement, second tranche | ||||
Disclosure of detailed information about borrowings [line items] | ||||
Term loan received | $ 50,000 |
BORROWING - Reconciliation of l
BORROWING - Reconciliation of liabilities arising from financing activities (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Borrowing | |||
Disclosure of reconciliation of liabilities arising from financing activities [line items] | |||
Beginning balance | $ 81,386 | ||
Proceeds from borrowings | 78,061 | ||
Principal and interest payments | (9,701) | (6,246) | |
Interest expense | 11,935 | 9,571 | |
Ending balance | 83,620 | 81,386 | |
Payable in respect of intangible assets purchase | |||
Disclosure of reconciliation of liabilities arising from financing activities [line items] | |||
Beginning balance | 24,746 | ||
Principal and interest payments | (8,500) | ||
Addition during the year | 22,288 | ||
Interest expense | 4,234 | 2,458 | |
Ending balance | 20,480 | 24,746 | |
Lease liabilities | |||
Disclosure of reconciliation of liabilities arising from financing activities [line items] | |||
Beginning balance | 5,517 | 3,815 | 1,667 |
Principal and interest payments | (2,107) | (1,802) | (1,047) |
Addition during the year | 385 | 2,930 | 2,805 |
Interest expense | 355 | 406 | 251 |
Foreign exchange movement | 42 | 168 | 139 |
Ending balance | $ 4,192 | $ 5,517 | $ 3,815 |
COMMITMENTS - Agreements to Pur
COMMITMENTS - Agreements to Purchase Intellectual Property (Details) | Jun. 30, 2014USD ($) | Aug. 11, 2010USD ($)item | Dec. 31, 2021USD ($)shares | Dec. 31, 2020USD ($) | Oct. 31, 2019shares | Oct. 17, 2019USD ($)shares | Dec. 31, 2018USD ($) | Mar. 30, 2015USD ($) |
Commercialization rights | ||||||||
Commitments | ||||||||
Commercialization rights at fair value | $ 11,800,000 | |||||||
Australian Asset Purchase Agreement | ||||||||
Commitments | ||||||||
Number of therapeutic candidates | item | 3 | |||||||
Upfront initial payment per agreement | $ 500,000 | |||||||
Aggregate payments made | $ 1,500,000 | |||||||
Australian Asset Purchase Agreement | Minimum | ||||||||
Commitments | ||||||||
Percentage of revenues to be paid in the future | 7.00% | |||||||
Australian Asset Purchase Agreement | Maximum | ||||||||
Commitments | ||||||||
Percentage of revenues to be paid in the future | 20.00% | |||||||
German Publicly Traded Company Arrangement | ||||||||
Commitments | ||||||||
Upfront initial payment per agreement | $ 1,000,000 | |||||||
German Publicly Traded Company Arrangement | Maximum | ||||||||
Commitments | ||||||||
Royalties percentage | 30.00% | |||||||
U.S. Private Company Arrangement | ||||||||
Commitments | ||||||||
Milestones to be paid | $ 2,000,000 | |||||||
Non-current liability | 750,000 | $ 750,000 | $ 500,000 | |||||
Aggregate payments made | $ 3,000,000 | 1,500,000 | ||||||
Cosmo Pharmaceuticals N.V. Strategic Collaboration | Cosmo Pharmaceuticals N.V. | ||||||||
Commitments | ||||||||
Investment in strategic collaboration | 36,300,000 | |||||||
Cosmo Pharmaceuticals N.V. Strategic Collaboration | Maximum | ||||||||
Commitments | ||||||||
Commitments in relation to joint ventures | $ 100,000,000 | |||||||
Revenue Milestone | U.S. Private Company Arrangement | Maximum | ||||||||
Commitments | ||||||||
Milestones to be paid | $ 2,000,000 | |||||||
Ordinary share | Cosmo Pharmaceuticals N.V. Strategic Collaboration | Cosmo Pharmaceuticals N.V. | ||||||||
Commitments | ||||||||
Number of shares issued | shares | 5,185,715 | |||||||
Ordinary share | Cosmo Pharmaceuticals N.V. Strategic Collaboration | Cosmo Technologies Ltd. | ||||||||
Commitments | ||||||||
Number of shares issued | shares | 1,714,286 | |||||||
Ordinary share | ADS | ||||||||
Commitments | ||||||||
Number of shares issued | shares | 12,522,245 | |||||||
Ordinary share | ADS | Cosmo Pharmaceuticals N.V. | ||||||||
Commitments | ||||||||
Number of shares issued | shares | 5,185,715 | |||||||
Ordinary share | ADS | Cosmo Technologies Ltd. | ||||||||
Commitments | ||||||||
Number of shares issued | shares | 1,714,286 |
COMMITMENTS - Movantik Acquisit
COMMITMENTS - Movantik Acquisition (Details) - USD ($) $ in Thousands | Apr. 01, 2020 | Apr. 30, 2020 | Oct. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Mar. 11, 2021 | Sep. 30, 2020 | Jul. 14, 2020 |
Disclosure of detailed information about intangible assets [line items] | |||||||||
Upfront payment for acquisition of rights | $ 53,368 | $ 35 | |||||||
Agreement amount payable for acquisition of rights | $ 23,000 | 26,000 | |||||||
Intangible assets | $ 71,644 | $ 87,879 | |||||||
Movantik | |||||||||
Disclosure of detailed information about intangible assets [line items] | |||||||||
Percentage of royalty based on sales | 20.00% | ||||||||
Intangible assets | $ 12,500 | ||||||||
Present value of total consideration | $ 65,000 | ||||||||
Useful life of assets (in years) | 10 years 6 months | 12 years 6 months | |||||||
Fee on net revenue for services received (as a percent) | 4.50% | ||||||||
Aemcolo | |||||||||
Disclosure of detailed information about intangible assets [line items] | |||||||||
Useful life of assets (in years) | 11 years | ||||||||
AstraZeneca AB | Movantik | |||||||||
Disclosure of detailed information about intangible assets [line items] | |||||||||
Upfront payment for acquisition of rights | $ 52,500 | ||||||||
Agreement amount payable for acquisition of rights | $ 16,000 | $ 15,500 | |||||||
Increase in agreement amount payable for acquisition of rights | $ 500 | ||||||||
Purchase commitment | $ 22,000 |
COMMITMENTS - DSI Agreement (De
COMMITMENTS - DSI Agreement (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2021 | Mar. 11, 2021 | Dec. 31, 2020 | Jul. 14, 2020 | |
Disclosure of classes of share capital [line items] | ||||
Agreement amount payable for acquisition of rights | $ 23,000 | $ 26,000 | ||
Intangible assets | $ 71,644 | $ 87,879 | ||
ADS | At-the-market equity offering program | ||||
Disclosure of classes of share capital [line items] | ||||
Number of shares issued | 87,624 | 2,837,038 | ||
Net proceeds from issuing shares | $ 800 | |||
Movantik | ||||
Disclosure of classes of share capital [line items] | ||||
Intangible assets | 12,500 | |||
Present value of future milestone payments | $ 10,500 | |||
Movantik | AstraZeneca AB | ||||
Disclosure of classes of share capital [line items] | ||||
Agreement amount payable for acquisition of rights | $ 16,000 | $ 15,500 | ||
Movantik | DSI | ADS | ||||
Disclosure of classes of share capital [line items] | ||||
Number of shares issued | 283,387 | |||
Financial component of issuance of stock | $ 2,000 | |||
Less than 1 year | Movantik | DSI | ||||
Disclosure of classes of share capital [line items] | ||||
Agreement amount payable for acquisition of rights | 5,100 | |||
July 2022 | Movantik | DSI | ||||
Disclosure of classes of share capital [line items] | ||||
Agreement amount payable for acquisition of rights | 5,000 | |||
July 2023 | Movantik | DSI | ||||
Disclosure of classes of share capital [line items] | ||||
Agreement amount payable for acquisition of rights | $ 5,000 |
INCOME TAX (Details)
INCOME TAX (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax [Line Items] | ||
Deductible temporary differences | $ 20 | $ 12 |
Israel | ||
Income Tax [Line Items] | ||
Corporate tax rate | 23.00% | |
Net operating losses | $ 265 | |
U.S. | ||
Income Tax [Line Items] | ||
Corporate tax rate | 21.00% | |
Net operating losses | $ 77 | |
U.S. | Net operating losses expiring in 2037 | ||
Income Tax [Line Items] | ||
Net operating losses | 10 | |
U.S. | Net operating losses with no expiration | ||
Income Tax [Line Items] | ||
Net operating losses | $ 67 |
SHARE CAPITAL (Details)
SHARE CAPITAL (Details) | 1 Months Ended | 12 Months Ended | |||||
Oct. 31, 2021USD ($)$ / sharesshares | Jul. 31, 2020USD ($)shares | Oct. 31, 2019USD ($)shares | Dec. 31, 2021USD ($)$ / shares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2021₪ / sharesshares | May 31, 2020₪ / sharesshares | |
Disclosure of classes of share capital [line items] | |||||||
Authorized ordinary shares | shares | 800,000,000 | ||||||
At-the-market equity offering program | ADS | |||||||
Disclosure of classes of share capital [line items] | |||||||
Number of shares issued | shares | 2,837,038 | 87,624 | |||||
Proceeds from issuance of shares | $ 800,000 | ||||||
Average share price | $ / shares | $ 9.03 | $ 8.62 | |||||
Share issuance expenses | $ 600,000 | ||||||
Authorised proceeds from issuance of shares | $ 23,800,000 | ||||||
At-the-market equity offering program | ADS | Maximum | |||||||
Disclosure of classes of share capital [line items] | |||||||
Proceeds from issuance of shares, gross | $ 100,000,000 | ||||||
Private Placements | ADS | Kukbo Co. Ltd. | |||||||
Disclosure of classes of share capital [line items] | |||||||
Authorised proceeds from issuance of shares | $ 10,000,000 | ||||||
Tranche One | ADS | Kukbo Co. Ltd. | |||||||
Disclosure of classes of share capital [line items] | |||||||
Number of shares issued | shares | 827,586 | ||||||
Authorised proceeds from issuance of shares | $ 5,000,000 | ||||||
Purchase price (per share) | $ / shares | $ 6.04 | ||||||
Share premium (as a percent) | 20.00% | ||||||
Number of days weighted average in determination of share premium | 30 days | ||||||
Tranche Two | ADS | Kukbo Co. Ltd. | |||||||
Disclosure of classes of share capital [line items] | |||||||
Proceeds from issuance of shares | $ 5,000,000 | ||||||
Authorised proceeds from issuance of shares | $ 5,000,000 | ||||||
Share premium (as a percent) | 20.00% | ||||||
Number of days weighted average in determination of share premium | 30 days | ||||||
Ordinary share | |||||||
Disclosure of classes of share capital [line items] | |||||||
Par value per share | ₪ / shares | ₪ 0.01 | ₪ 0.01 | |||||
Authorized ordinary shares | shares | 794,000,000 | 794,000,000 | 794,000,000 | ||||
Issued and paid ordinary shares | shares | 383,981,000 | 524,016,000 | |||||
Ordinary share | ADS | |||||||
Disclosure of classes of share capital [line items] | |||||||
Number of shares issued | shares | 12,522,245 | ||||||
Proceeds from issuance of shares, gross | $ 77,000,000 | ||||||
Proceeds from issuance of shares | 72,700,000 | ||||||
Ordinary share | ADS | Cosmo Pharmaceuticals N.V. | |||||||
Disclosure of classes of share capital [line items] | |||||||
Number of shares issued | shares | 5,185,715 | ||||||
Proceeds from issuance of shares | $ 36,300,000 | ||||||
Ordinary share | ADS | Cosmo Technologies Ltd. | |||||||
Disclosure of classes of share capital [line items] | |||||||
Number of shares issued | shares | 1,714,286 | ||||||
Ordinary share | ADS | DSI | |||||||
Disclosure of classes of share capital [line items] | |||||||
Number of shares issued | shares | 283,387 | ||||||
Proceeds from issuance of shares | $ 2,000,000 | ||||||
Ordinary share | Stock Options | |||||||
Disclosure of classes of share capital [line items] | |||||||
Number of shares issued | shares | 8,156 | 565,998 | |||||
Proceeds from exercise of options | $ 4 | $ 52,000 | |||||
Preferred shares | |||||||
Disclosure of classes of share capital [line items] | |||||||
Par value per share | ₪ / shares | ₪ 0.01 | ||||||
Authorized ordinary shares | shares | 6,000,000 | ||||||
Authorized preferred shares (reserved) | shares | 6,000,000 | 6,000,000 |
SHARE-BASED PAYMENTS (Details)
SHARE-BASED PAYMENTS (Details) | Dec. 31, 2021USD ($)Optionshares | Jul. 26, 2021USD ($) | May 04, 2020USD ($) | Dec. 31, 2021USD ($)Optioninstallment$ / shares | Dec. 31, 2020USD ($)Option$ / shares | Dec. 31, 2019USD ($) |
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 2,533,781 | 1,651,000 | ||||
Exercise price for 1 ADS ($) | $ / shares | $ 7.05 | $ 6.90 | ||||
Fair value of options on date of grant in U.S. dollars in thousands | $ 5,233,000 | |||||
Expense recognized | $ 10,212,000 | $ 4,202,000 | $ 3,027,000 | |||
Number of options cancelled | Option | 575,095 | 264,939 | ||||
Each option exercisable into number of ordinary shares, ratio | Option | 3,615,662 | 3,615,662 | 3,178,317 | |||
2020 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 219,000 | |||||
January 2020 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 95,000 | |||||
Exercise price for 1 ADS ($) | $ / shares | $ 6.60 | |||||
Fair value of options on date of grant in U.S. dollars in thousands | $ 243,000 | |||||
February 2020 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 52,500 | |||||
Exercise price for 1 ADS ($) | $ / shares | $ 6.05 | |||||
Fair value of options on date of grant in U.S. dollars in thousands | $ 119,000 | |||||
March 2020 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 285,000 | |||||
Exercise price for 1 ADS ($) | $ / shares | $ 4.87 | |||||
Fair value of options on date of grant in U.S. dollars in thousands | $ 683,000 | |||||
May 2020 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 362,000 | |||||
Exercise price for 1 ADS ($) | $ / shares | $ 7.50 | |||||
Fair value of options on date of grant in U.S. dollars in thousands | $ 1,118,000 | |||||
June 2020 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 767,500 | |||||
Exercise price for 1 ADS ($) | $ / shares | $ 7.72 | |||||
Fair value of options on date of grant in U.S. dollars in thousands | $ 2,671,000 | |||||
July 2020 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 12,500 | |||||
Exercise price for 1 ADS ($) | $ / shares | $ 7.69 | |||||
Fair value of options on date of grant in U.S. dollars in thousands | $ 45,000 | |||||
August 2020 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 55,500 | |||||
Exercise price for 1 ADS ($) | $ / shares | $ 8.72 | |||||
Fair value of options on date of grant in U.S. dollars in thousands | $ 264,000 | |||||
November 2020 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 21,000 | |||||
Exercise price for 1 ADS ($) | $ / shares | $ 10.20 | |||||
Fair value of options on date of grant in U.S. dollars in thousands | $ 90,000 | |||||
2021 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 310,341 | 2,533,781 | ||||
Fair value of options on date of grant in U.S. dollars in thousands | $ 10,221,000 | $ 10,221,000 | ||||
March 2021 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 40,500 | |||||
Exercise price for 1 ADS ($) | $ / shares | $ 9.44 | |||||
Fair value of options on date of grant in U.S. dollars in thousands | 151,000 | $ 151,000 | ||||
April 2021 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 2,036,440 | |||||
Exercise price for 1 ADS ($) | $ / shares | $ 7.08 | |||||
Fair value of options on date of grant in U.S. dollars in thousands | 8,274,000 | $ 8,274,000 | ||||
May 2021 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 22,500 | |||||
Exercise price for 1 ADS ($) | $ / shares | $ 7.05 | |||||
Fair value of options on date of grant in U.S. dollars in thousands | 90,000 | $ 90,000 | ||||
July 2021 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 327,341 | |||||
Fair value of options on date of grant in U.S. dollars in thousands | 1,377,000 | $ 1,377,000 | ||||
July 2021 | Minimum | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Exercise price for 1 ADS ($) | $ / shares | $ 6.9 | |||||
July 2021 | Maximum | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Exercise price for 1 ADS ($) | $ / shares | $ 7.08 | |||||
August 2021 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 53,500 | |||||
Fair value of options on date of grant in U.S. dollars in thousands | 210,000 | $ 210,000 | ||||
August 2021 | Minimum | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Exercise price for 1 ADS ($) | $ / shares | $ 6.97 | |||||
August 2021 | Maximum | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Exercise price for 1 ADS ($) | $ / shares | $ 7.18 | |||||
September 2021 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 12,000 | |||||
Exercise price for 1 ADS ($) | $ / shares | $ 4.56 | |||||
Fair value of options on date of grant in U.S. dollars in thousands | 31,000 | $ 31,000 | ||||
November 2021 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 24,500 | |||||
Exercise price for 1 ADS ($) | $ / shares | $ 4.54 | |||||
Fair value of options on date of grant in U.S. dollars in thousands | 63,000 | $ 63,000 | ||||
December 2021 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 17,000 | |||||
Exercise price for 1 ADS ($) | $ / shares | $ 2.65 | |||||
Fair value of options on date of grant in U.S. dollars in thousands | $ 26,000 | $ 26,000 | ||||
Stock Options | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Shares approved for issuance | shares | 59,206,448 | |||||
Stock Options | Exchange Offer | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 2,805,281 | |||||
Incremental value measured | $ 3,500,000 | |||||
Expense recognized | $ 3,300,000 | |||||
Stock Options | Minimum | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Exercise price for 1 ADS ($) | $ / shares | $ 4.3 | $ 4.28 | ||||
Expected volatility | 58.80% | 57.73% | ||||
Risk free interest rate | 0.01% | 0.64% | ||||
Stock Options | Maximum | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Exercise price for 1 ADS ($) | $ / shares | $ 7 | $ 9.19 | ||||
Expected volatility | 65.28% | 63.63% | ||||
Risk free interest rate | 2.31% | 1.51% | ||||
Stock Options | 2021 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Option term | 10 years | |||||
Stock Options | 2021 | Minimum | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Price of the Company's ordinary shares | $ / shares | $ 4.28 | |||||
Expected volatility | 64.05% | |||||
Risk free interest rate | 1.26% | |||||
Stock Options | 2021 | Maximum | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Price of the Company's ordinary shares | $ / shares | $ 9.19 | |||||
Expected volatility | 66.65% | |||||
Risk free interest rate | 1.73% | |||||
Stock Options | 2021 | Vesting, services exceeding one year | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of equal quarterly vesting installments | installment | 16 | |||||
Vesting period | 4 years | |||||
Stock Options | 2021 | Vesting, services exceeding one year | Minimum | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Service period | 1 year | |||||
Stock Options | 2021 | Vesting, services not exceeding one year | Maximum | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Service period | 1 year | |||||
Stock Options | 2021 | Vesting, one year following the date of grant (services not exceeding one year) | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Vesting period | 1 year | |||||
Percentage of options vesting | 0.25% | |||||
Stock Options | 2021 | Vesting, three years following one year after the date of grant (services not exceeding one year) | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of equal quarterly vesting installments | installment | 12 | |||||
Other than directors | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 1,432,000 | |||||
Other than directors | January 2020 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 95,000 | |||||
Other than directors | February 2020 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 52,500 | |||||
Other than directors | March 2020 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 285,000 | |||||
Other than directors | May 2020 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 143,000 | |||||
Other than directors | June 2020 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 767,500 | |||||
Other than directors | July 2020 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 12,500 | |||||
Other than directors | August 2020 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 55,500 | |||||
Other than directors | November 2020 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 21,000 | |||||
Other than directors | 2021 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 2,223,440 | |||||
Other than directors | March 2021 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 40,500 | |||||
Other than directors | April 2021 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 2,036,440 | |||||
Other than directors | May 2021 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 22,500 | |||||
Other than directors | July 2021 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 17,000 | |||||
Other than directors | August 2021 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 53,500 | |||||
Other than directors | September 2021 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 12,000 | |||||
Other than directors | November 2021 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 24,500 | |||||
Other than directors | December 2021 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 17,000 | |||||
To directors | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 219,000 | |||||
To directors | May 2020 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 219,000 | |||||
To directors | 2021 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 310,341 | |||||
To directors | July 2021 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 310,341 |
SHARE-BASED PAYMENTS - Number o
SHARE-BASED PAYMENTS - Number of Options and Weighted Averages of Exercise Prices (Details) | 12 Months Ended | |||
Dec. 31, 2021Option$ / shares | Dec. 31, 2020OptionUSD ($)$ / shares | Dec. 31, 2020Option$ / shares | Dec. 31, 2020Option$ / shares | |
SHARE-BASED PAYMENTS | ||||
Number of options, outstanding at beginning of year | Option | 5,428,803 | 4,050,898 | ||
Number of options, exercised | Option | (565,998) | (8,156) | ||
Number of options, expired and forfeited | Option | (575,095) | (264,939) | ||
Number of options, granted | 2,533,781 | 1,651,000 | 1,651,000 | |
Number of options, outstanding at end of year | Option | 6,821,491 | 5,428,803 | ||
Number of options, exercisable at end of year | Option | 3,615,662 | 3,178,317 | 3,178,317 | 3,178,317 |
Weighted average of exercise price, outstanding at beginning of year | $ 9.08 | $ 10.30 | ||
Weighted average of exercise price, exercised | 7.08 | 6.38 | ||
Weighted average of exercise price, expired and forfeited | 8.02 | 9.65 | ||
Weighted average of exercise price, granted | 7.05 | 6.90 | ||
Weighted average of exercise price, outstanding at end of year | 6.50 | 9.08 | ||
Weighted average of exercise price, exercisable at end of year | $ 6.14 | $ 10.19 | $ 10.19 | $ 10.19 |
SHARE-BASED PAYMENTS - Informat
SHARE-BASED PAYMENTS - Information About Exercise Price and Remaining Useful Life of Outstanding Options (Details) | 12 Months Ended | ||
Dec. 31, 2021Option$ / shares | Dec. 31, 2020Option$ / shares | Dec. 31, 2019Option | |
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items] | |||
Number of options outstanding at end of Year | Option | 6,821,491 | 5,428,803 | 4,050,898 |
Weighted average of remaining useful life | 6 years 9 months 18 days | 5 years 10 months 24 days | |
Minimum | |||
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items] | |||
Exercise price range | $ 2.65 | $ 5.6 | |
Maximum | |||
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items] | |||
Exercise price range | $ 15.6 | $ 16.1 |
SHARE-BASED PAYMENTS - Expenses
SHARE-BASED PAYMENTS - Expenses Recognized in Profit or Loss (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
SHARE-BASED PAYMENTS | |||
Expenses recognized in profit or loss | $ 10,212 | $ 4,202 | $ 3,027 |
Unrecognized compensation expenses | $ 7,600 |
NET REVENUES (Details)
NET REVENUES (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenues | |||
Other products | $ 8,989 | $ 5,003 | $ 6,291 |
Revenue | 85,757 | 64,359 | 6,291 |
Revenue from promotional services | 3,100 | ||
Revenue from commercialization of products | $ 3,200 | ||
Movantik | |||
Revenues | |||
Revenues | $ 76,767 | $ 59,356 |
RESEARCH AND DEVELOPMENT EXPE_3
RESEARCH AND DEVELOPMENT EXPENSES (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Research And Development Expenses Net [Line Items] | |||
Research and development expenses | $ 29,498 | $ 16,491 | $ 17,419 |
Payroll and related expenses | |||
Research And Development Expenses Net [Line Items] | |||
Research and development expenses, gross | 839 | 636 | 623 |
Professional services and consulting fees | |||
Research And Development Expenses Net [Line Items] | |||
Research and development expenses, gross | 1,821 | 1,752 | 2,345 |
Share-based payments | |||
Research And Development Expenses Net [Line Items] | |||
Research and development expenses, gross | 1,910 | 883 | 671 |
Clinical and pre-clinical trials | |||
Research And Development Expenses Net [Line Items] | |||
Research and development expenses, gross | 23,905 | 12,569 | 12,840 |
Intellectual property development | |||
Research And Development Expenses Net [Line Items] | |||
Research and development expenses, gross | 349 | 298 | 317 |
Other | |||
Research And Development Expenses Net [Line Items] | |||
Research and development expenses, gross | $ 674 | $ 353 | $ 623 |
SELLING AND MARKETING EXPENSE_2
SELLING AND MARKETING EXPENSES (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Selling Marketing And Business Development Expenses [Line Items] | |||
Selling, and marketing expenses | $ 55,623 | $ 49,285 | $ 18,333 |
Payroll and related expenses | |||
Selling Marketing And Business Development Expenses [Line Items] | |||
Selling, and marketing expenses | 24,227 | 20,756 | 9,335 |
Share-based payments | |||
Selling Marketing And Business Development Expenses [Line Items] | |||
Selling, and marketing expenses | 2,570 | 1,464 | 941 |
Professional services | |||
Selling Marketing And Business Development Expenses [Line Items] | |||
Selling, and marketing expenses | 17,441 | 18,957 | 3,680 |
Samples | |||
Selling Marketing And Business Development Expenses [Line Items] | |||
Selling, and marketing expenses | 1,008 | 438 | 178 |
Travel, fleet, meals and related expenses | |||
Selling Marketing And Business Development Expenses [Line Items] | |||
Selling, and marketing expenses | 7,305 | 5,729 | 2,193 |
Office related expenses | |||
Selling Marketing And Business Development Expenses [Line Items] | |||
Selling, and marketing expenses | 1,285 | 957 | 789 |
Other | |||
Selling Marketing And Business Development Expenses [Line Items] | |||
Selling, and marketing expenses | $ 1,787 | $ 984 | $ 1,217 |
GENERAL AND ADMINISTRATIVE EX_3
GENERAL AND ADMINISTRATIVE EXPENSES (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
General And Administrative Expense [Line Items] | |||
General and administrative expenses | $ 32,365 | $ 25,375 | $ 11,481 |
Payroll and related expenses | |||
General And Administrative Expense [Line Items] | |||
General and administrative expenses | 11,974 | 11,159 | 4,903 |
Share-based payments | |||
General And Administrative Expense [Line Items] | |||
General and administrative expenses | 5,732 | 1,855 | 1,415 |
Professional services | |||
General And Administrative Expense [Line Items] | |||
General and administrative expenses | 11,040 | 9,132 | 3,479 |
Medical affairs | |||
General And Administrative Expense [Line Items] | |||
General and administrative expenses | 1,600 | 1,052 | 299 |
Office related expenses | |||
General And Administrative Expense [Line Items] | |||
General and administrative expenses | 1,438 | 1,168 | 585 |
Other | |||
General And Administrative Expense [Line Items] | |||
General and administrative expenses | $ 581 | $ 1,009 | $ 800 |
FINANCIAL EXPENSES (INCOME), _3
FINANCIAL EXPENSES (INCOME), net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
FINANCIAL EXPENSES (INCOME), net | |||
Fair value gain on derivative financial instruments | $ 344 | ||
Gains on financial assets at fair value through profit or loss | $ 94 | 474 | |
Gain from changes in exchange rates | 74 | ||
Interest from bank deposits | $ 51 | 176 | 443 |
Financial income | 51 | 270 | 1,335 |
Interest and finance charges for lease liabilities | 395 | 405 | 390 |
Loss from changes in exchange rates | 28 | 9 | |
Interest expenses related to borrowing and payable in respect of intangible assets purchase | 16,172 | 12,045 | |
Other | 65 | 300 | 48 |
Financial expenses | 16,660 | 12,759 | 438 |
Financial expenses (income), net | $ 16,609 | $ 12,489 | $ (897) |
SEGMENT INFORMATION (Details)
SEGMENT INFORMATION (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Disclosure of operating segments [line items] | |||
Financial expenses (income), net | $ 16,609 | $ 12,489 | $ (897) |
Share-based compensation to employees and service providers | 10,212 | 4,202 | 3,027 |
Depreciation | 1,914 | 1,710 | 997 |
Amortization and impairment of intangible assets | 16,235 | 7,035 | 216 |
LOSS AND COMPREHENSIVE LOSS FOR THE YEAR | (97,744) | (76,173) | (42,304) |
Commercial Operations | |||
Disclosure of operating segments [line items] | |||
Adjusted EBITDA | (15,527) | (27,236) | (15,913) |
Research and Development | |||
Disclosure of operating segments [line items] | |||
Adjusted EBITDA | $ (37,247) | $ (23,501) | $ (23,048) |
SEGMENT INFORMATION - Major Cus
SEGMENT INFORMATION - Major Customers and Segment Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Disclosure of major customers [line items] | |||
Non-current assets | $ 92,036 | $ 109,746 | |
Intangible assets | 71,644 | 87,879 | |
Restricted cash | 16,169 | 16,164 | |
Right-of-use assets | 3,651 | $ 5,192 | |
Israel | |||
Disclosure of major customers [line items] | |||
Non-current assets | 7,000 | ||
Intangible assets | 5,600 | ||
Right-of-use assets | 1,100 | ||
U.S. | |||
Disclosure of major customers [line items] | |||
Non-current assets | 84,900 | ||
Intangible assets | 66,000 | ||
Restricted cash | 16,000 | ||
Right-of-use assets | $ 2,500 | ||
Minimum | |||
Disclosure of major customers [line items] | |||
Payment terms for customers | 30 days | ||
Maximum | |||
Disclosure of major customers [line items] | |||
Payment terms for customers | 60 days | ||
Customer A | |||
Disclosure of major customers [line items] | |||
Percentage of revenue | 32.00% | 35.00% | |
Customer B | |||
Disclosure of major customers [line items] | |||
Percentage of revenue | 31.00% | 28.00% | |
Customer C | |||
Disclosure of major customers [line items] | |||
Percentage of revenue | 32.00% | 35.00% | 10.00% |
Customer D | |||
Disclosure of major customers [line items] | |||
Percentage of revenue | 45.00% | ||
Customer E | |||
Disclosure of major customers [line items] | |||
Percentage of revenue | 18.00% |
LOSS PER ORDINARY SHARE - Basic
LOSS PER ORDINARY SHARE - Basic (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Basic | |||
Loss (U.S. dollars in thousands) | $ 97,744 | $ 76,173 | $ 42,304 |
Weighted average number of ordinary shares outstanding during the period (in thousands) | 465,273 | 364,276 | 296,922 |
Basic loss per share (U.S. dollars) | $ 0.21 | $ 0.21 | $ 0.14 |
RELATED PARTIES - Key Managemen
RELATED PARTIES - Key Management Compensation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
RELATED PARTIES | |||
Salaries and other short-term employee benefits | $ 1,668 | $ 1,526 | $ 876 |
Post-employment benefits | 91 | 61 | 43 |
Share-based payments | 1,611 | 661 | 468 |
Other long-term benefits | $ 54 | $ 33 | $ 26 |
RELATED PARTIES - Balances with
RELATED PARTIES - Balances with Related Parties (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current liabilities | ||
Credit balance in "accrued expenses and other current liabilities" | $ 399 | $ 484 |
EVENTS SUBSEQUENT TO DECEMBER_2
EVENTS SUBSEQUENT TO DECEMBER 31, 2021 (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 2 Months Ended | 12 Months Ended | ||
Mar. 17, 2022 | Mar. 17, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Jan. 20, 2022 | |
At-the-market equity offering program | ADS | |||||
Disclosure of non-adjusting events after reporting period [line items] | |||||
Number of shares issued | 87,624 | 2,837,038 | |||
Average share price | $ 9.03 | $ 8.62 | |||
Proceeds from issuance of shares | $ 0.8 | ||||
Event subsequent to reporting period | At-the-market equity offering program | ADS | |||||
Disclosure of non-adjusting events after reporting period [line items] | |||||
Number of shares issued | 282,626 | 282,626 | |||
Average share price | $ 2.2 | ||||
Proceeds from issuance of shares | $ 0.6 | ||||
Event subsequent to reporting period | Gaelan | |||||
Disclosure of non-adjusting events after reporting period [line items] | |||||
Upfront payments received | $ 2 | ||||
Event subsequent to reporting period | Kukbo Co. Ltd. | |||||
Disclosure of non-adjusting events after reporting period [line items] | |||||
Upfront payments received | 1.5 | ||||
Event subsequent to reporting period | Kukbo Co. Ltd. | Maximum | |||||
Disclosure of non-adjusting events after reporting period [line items] | |||||
Milestones to be paid | $ 5.6 | $ 5.6 | |||
RSUs | Event subsequent to reporting period | |||||
Disclosure of non-adjusting events after reporting period [line items] | |||||
Estimated fair value on the grant date | $ 6 | ||||
RSUs | Event subsequent to reporting period | Officers, employees, and consultants | |||||
Disclosure of non-adjusting events after reporting period [line items] | |||||
Number of shares approved for grant | 1,920,500 | ||||
Number of American depository shares for each restricted stock unit | 1 | ||||
RSUs | Event subsequent to reporting period | Directors and Chief Executive Officer | |||||
Disclosure of non-adjusting events after reporting period [line items] | |||||
Number of shares approved for grant | 140,000 |