Document and Entity Information
Document and Entity Information | 12 Months Ended |
Dec. 31, 2020shares | |
Document and Entity Information [Abstract] | |
Document Type | 20-F |
Document Registration Statement | false |
Document Annual Report | true |
Document Period End Date | Dec. 31, 2020 |
Document Transition Report | false |
Document Shell Company Report | false |
Entity Registrant Name | RedHill Biopharma Ltd. |
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 Common Stock, Shares Outstanding | 383,981,464 |
Entity Emerging Growth Company | false |
ICFR Auditor Attestation Flag | true |
Entity Shell Company | false |
Amendment Flag | false |
Entity Central Index Key | 0001553846 |
Current Fiscal Year End Date | --12-31 |
Document Fiscal Year Focus | 2020 |
Document Fiscal Period Focus | FY |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | |||
NET REVENUES | $ 64,359 | $ 6,291 | $ 8,360 |
COST OF REVENUES | 36,892 | 2,259 | 2,837 |
GROSS PROFIT | 27,467 | 4,032 | 5,523 |
RESEARCH AND DEVELOPMENT EXPENSES | 16,491 | 17,419 | 24,862 |
SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES | 49,285 | 18,333 | 12,486 |
GENERAL AND ADMINISTRATIVE EXPENSES | 25,375 | 11,481 | 7,506 |
OPERATING LOSS | 63,684 | 43,201 | 39,331 |
FINANCIAL INCOME | 270 | 1,335 | 678 |
FINANCIAL EXPENSES | 12,759 | 438 | 167 |
FINANCIAL EXPENSES (INCOME), net | 12,489 | (897) | (511) |
LOSS AND COMPREHENSIVE LOSS FOR THE YEAR | $ 76,173 | $ 42,304 | $ 38,820 |
LOSS PER ORDINARY SHARE, basic and diluted (U.S. dollars): | $ 0.21 | $ 0.14 | $ 0.17 |
CONSOLIDATED STATEMENTS OF FINA
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 29,295 | $ 29,023 |
Bank deposits | 17 | 10,349 |
Financial assets at fair value through profit or loss | 481 | 8,500 |
Trade receivables | 28,655 | 1,216 |
Prepaid expenses and other receivables | 5,521 | 2,244 |
Inventory | 6,526 | 1,882 |
Total current assets | 70,495 | 53,214 |
NON-CURRENT ASSETS: | ||
Restricted cash | 16,164 | 152 |
Fixed assets | 511 | 228 |
Right-of-use assets | 5,192 | 3,578 |
Intangible assets | 87,879 | 16,927 |
Total non-current assets | 109,746 | 20,885 |
TOTAL ASSETS | 180,241 | 74,099 |
CURRENT LIABILITIES: | ||
Accounts payable | 11,553 | 4,184 |
Lease liabilities | 1,710 | 834 |
Allowance for deductions from revenue | 18,343 | 1,267 |
Accrued expenses and other current liabilities | 24,082 | 4,331 |
Payable in respect of intangible asset purchase | 17,547 | |
Total current liabilities | 73,235 | 10,616 |
NON-CURRENT LIABILITIES: | ||
Borrowing | 81,386 | |
Payable in respect of intangible assets purchase | 7,199 | |
Lease liabilities | 3,807 | 2,981 |
Royalty obligation | 750 | 500 |
Total non-current liabilities | 93,142 | 3,481 |
TOTAL LIABILITIES | 166,377 | 14,097 |
EQUITY: | ||
Ordinary shares | 1,054 | 962 |
Additional paid-in capital | 293,144 | 267,403 |
Accumulated deficit | (280,334) | (208,363) |
TOTAL EQUITY | 13,864 | 60,002 |
TOTAL LIABILITIES AND EQUITY | $ 180,241 | $ 74,099 |
CONSOLIDATED STATEMENTS OF CHAN
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY - USD ($) $ in Thousands | Ordinary shares | Additional paid-in capital | Accumulated deficit | Total |
Balance at beginning of period at Dec. 31, 2017 | $ 575 | $ 177,434 | $ (132,944) | $ 45,065 |
Share-based compensation to employees and service providers | 2,678 | 2,678 | ||
Issuance of ordinary shares | 190 | 41,712 | 41,902 | |
Exercise of options into ordinary shares | 2 | 359 | 361 | |
Comprehensive loss | (38,820) | |||
Balance at end 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 | 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 | 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 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
OPERATING ACTIVITIES: | |||
Comprehensive loss | $ (76,173) | $ (42,304) | $ (38,820) |
Adjustments in respect of income and expenses not involving cash flow: | |||
Share-based compensation to employees and service providers | 4,202 | 3,027 | 2,678 |
Depreciation | 1,710 | 997 | 90 |
Amortization and impairment of intangible assets | 7,035 | 216 | |
Non-cash interest expenses related to borrowing and payable in respect of intangible assets purchase and royalty obligation | 6,032 | ||
Fair value adjustments on derivative financial instruments | (344) | (104) | |
Fair value losses (gains) on financial assets at fair value through profit or loss | 94 | (27) | 137 |
Exchange differences and revaluation of bank deposits | 101 | 24 | 138 |
Total adjustments in respect of income and expenses not involving cash flow | 19,174 | 3,893 | 2,939 |
Changes in assets and liability items: | |||
Decrease (increase) in trade receivables | (27,439) | (258) | 570 |
Decrease (increase) in prepaid expenses and other receivables | (3,277) | (368) | 1,414 |
Increase in inventories | (4,644) | (1,113) | (116) |
Increase (decrease) in accounts payable | 7,369 | 860 | (1,481) |
Increase (decrease) in accrued expenses and other liabilities | 19,335 | (2,726) | 722 |
Increase in allowance for deductions from revenue | 17,076 | 1,267 | 310 |
Total changes in assets and liability items | 8,420 | (2,338) | 1,419 |
Net cash used in operating activities | (48,579) | (40,749) | (34,462) |
INVESTING ACTIVITIES: | |||
Purchase of fixed assets | (406) | (168) | (23) |
Purchase of intangible assets | (53,368) | (35) | (35) |
Change in investment in current bank deposits | 10,200 | (2,069) | 4,869 |
Purchase of financial assets at fair value through profit or loss | (4,325) | (6,976) | |
Proceeds from sale of financial assets at fair value through profit or loss | 7,925 | 11,761 | 7,517 |
Net cash provided by (used in) investing activities | (35,649) | 5,164 | 5,352 |
FINANCING ACTIVITIES: | |||
Proceeds from issuance of ordinary shares, net of issuance costs | 23,867 | 36,300 | 41,902 |
Exercise of options into ordinary shares | 52 | 5 | 361 |
Proceeds from long-term borrowing, net of transaction costs | 78,061 | ||
Increase in restricted cash | (20,000) | ||
Decrease in restricted cash | 4,000 | ||
Payment of principal with respect to lease liabilities | (1,610) | (796) | |
Repayment of payable in respect of intangible asset purchase | (500) | ||
Net cash provided by financing activities | 84,370 | 35,509 | 41,763 |
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 142 | (76) | 12,653 |
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS | 130 | 94 | (103) |
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 29,023 | 29,005 | 16,455 |
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD | 29,295 | 29,023 | 29,005 |
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH | 414 | 753 | $ 728 |
SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH | 6,654 | 251 | |
Acquisition of right-of-use assets by means of lease liabilities | 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, 2020 | |
GENERAL | |
GENERAL | NOTE 1 - GENERAL: a. General: 1) RedHill Biopharma Ltd. (the “Company”), incorporated on August 3, 2009, together with its wholly-owned subsidiary, RedHill Biopharma Inc. (“RedHill Inc.”), incorporated in Delaware, U.S. on January 19, 2017, is a specialty biopharmaceutical company primarily focused on gastrointestinal (“GI”) diseases and infectious diseases. 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, acquired through in-licensing or through co-promotion agreements. As of the date of approval of these financial statements, the Company commercializes in the U.S., 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, Movantik ® , for the treatment of opioid-induced constipation, and Aemcolo ® (rifamycin), for traveler’s diarrhea. On February 23, 2020, RedHill Inc. entered into an exclusive license agreement (the “License Agreement”) with AstraZeneca AB (“AstraZeneca”) pursuant to which AstraZeneca granted RedHill Inc. exclusive, worldwide (excluding Europe, Canada and Israel) commercialization and development rights to Movantik ® (naloxegol). In addition, RedHill Inc. entered into a supply agreement (“Supply Agreement”) and a transitional services agreement (“TSA”) with AstraZeneca, pursuant to which AstraZeneca provides RedHill Inc. certain technology transfers and related materials for an agreed period to enable the Company to manufacture and distribute Movantik ® through its own supply chain, as well as various other supporting services over certain agreed periods. On October 6, 2020, the parties amended the License Agreement to grant RedHill Inc. also the exclusive commercialization and development rights to Movantik ® (naloxegol) in Israel. See note 16(a)(5). 3) Through December 31, 2020, the Company has an accumulated deficit and its activities have been funded primarily through public and private offerings of the Company’s securities and borrowing. There is no assurance that the Company’s business will generate sustainable positive cash flows. 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. See note 28 with respect to an offering completed by the Company subsequent to December 31, 2020. 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, 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. 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 ® for H. pylori infection and Aemcolo ® for travelers’ diarrhea. 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. See also note 3 and note 11(b) regarding the impairment test performed by the Company. b. Approval of the financial statements: These financial statements were approved by the Board of Directors (the "BoD") on March 3, 2021. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2020 | |
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 (“EUR”) 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 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 for approved products Commercialization assets"). R&D assets are stated at cost and are not amortized. These assets are tested for impairment at least annually. At the time these assets will be available for use, they will be amortized over their useful lives. Commercialization assets are stated at cost and are amortized on a straight-line basis over their useful economic life when they are available for use. These assets are subsequently carried at cost less accumulated amortization and impairment losses. In determining the useful economic life of a commercialization asset, the Company considered, among other factors, the duration of the license, patent and regulatory data exclusivities of the product, anticipated duration of sales of the product following loss of exclusivity, and competitors in the marketplace. 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 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 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) Recognition and measurement 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) Impairment 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’s ordinary shares are classified as the Company’s share capital. Incremental costs directly attributed to the issuance of new shares or warrants are presented under equity as a deduction from the proceeds of issuance. 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(a)(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 . The Company offers discounts to its customers, as an incentive for prompt payment. The Company records these discounts as a reduction of revenue in the period the related revenue from the sale of products is recognized. In addition, distribution fees are paid to certain distributors based on contractually determined rates from the gross consideration. As the fee paid to the customer is not for a distinct good or service, it is recognized as a reduction of revenue in the period the related revenue from the sale of products is recognized. Rebates and patient discount programs. The Company offers various rebate and patient discount programs, which result in discounted prescriptions to qualified patients. The Company estimates the allowance for these rebates and coupons based on historical and estimated utilization of the rebate and discount programs, at the time the revenues are recognized. These estimates are recognized as a reduction of revenue. Product returns. The Company offers customers a right of return. The Company estimates the amount of product sales that may be returned by its customers and records this estimate as a reduction of revenue at the time of sale, based on historical rates of return, or, if such historical data is not available, the Company estimates product returns based on its own sales information, its visibility into the inventory remaining in the distribution channel and product dating. At the end of each reporting period, the Company may decide to constrain revenue for product returns based on information from various sources. Principal versus agent considerations . When a third party is involved in providing goods or services to a customer, the Company analyzes whether the Company acts as a principal or an agent in the transaction, based on whether the Company obtains control of the product before it is transferred to the customer, using the indicators provided in IFRS 15, including: primary responsibility for fulfilling the promise to provide the products to its customers, inventory risk before and after transfer to the customers and discretion in establishing the selling price of each product. When determined to be the principal in the arrangements, the Company recognizes revenues in the gross amount it expects to be entitled in exchange for the products transferred to the customers. 2) Revenue from promotional services In 2020, the Company terminated the promotional agreements and recognized immaterial revenues from promotional services. In 2019 and 2018, 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 samples of the commercialized products. These costs are recognized as an expense when incurred. 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 a) The Company has adopted IFRS 16 retrospectively from January 1, 2019, but has not restated comparatives for the 2018 reporting period, as permitted under the specific transitional provisions in the standard. The reclassifications and the adjustments arising from the new leasing rules are therefore recognized in the statement of financial position at the date of initial application. On adoption of IFRS 16, the Company recognized lease liabilities in relation to leases that had previously been classified as ‘operating leases’ under the principles of IAS 17 “Leases.” These liabilities were measured at the present value of the remaining lease payments, discounted using the lessee’s incremental borrowing rate as of January 1, 2019. The weighted average lessee’s incremental annual borrowing rate applied to the lease liabilities on January 1, 2019, was 6.9%. The associated right-of-use assets were measured at the amount equal to the lease liability and as a result, there was no impact on accumulated deficit on January 1, 2019. In applying IFRS 16 for the first time, the Company has used the following practical expedient permitted by the standard - the accounting for operating leases with a remaining lease term of less than 12 months as of January 1, 2019, as short-term leases. The Company has also elected not to reassess whether a contract is or contains a lease at the date of initial application. Instead, for contracts entered into before the transition date, the Company relied on its assessment made applying IAS 17 and IFRIC 4 determining whether an arrangement contains a lease. b) 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. c) Until the 2018 financial year, the leases of offices and cars by the Company and its subsidiary were classified as operating leases and payments made were charged to profit or loss on a straight-line basis over the period of the lease. s . Recently adopted pronouncements Amendments to IFRS 3 'business combinations' - Definition of a Business ("the amendment"). The amended definition of a business requires an acquisition to include an input and a substantive process that together significantly contribute to the ability to create outputs. The definition of the term ‘outputs’ is amended to focus on goods and services provided to customers, generating investment income and other income, and it excludes returns in the form of lower costs and other economic benefits. The amendment also provides an optional test - the concentration test. If substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or a group of similar identifiable assets, then the acquired set of assets and activities are not considered a business. The Company applied the amendment to IFRS 3 prospectively as from January 1, 2020. See also note 16a(5) for the acquisition of Movantik ® . |
CRITICAL ACCOUNTING ESTIMATES A
CRITICAL ACCOUNTING ESTIMATES AND JUDGMENTS | 12 Months Ended |
Dec. 31, 2020 | |
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 that the most critical accounting policies and significant areas of judgment and estimation are in: · Recognition and measurement of allowance for rebates and patient discount programs · Impairment reviews of intangible R&D assets · Estimated recoverable amount and useful economic life of the Aemcolo ® asset . · Estimated useful economic 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. 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 17%. 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 and useful economic life of the Aemcolo ® asset The Aemcolo ® asset was acquired in October 2019 in exchange of the Company’s ADSs and was recognized at fair value at the acquisition date. Following the outbreak 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 ® , for traveler’s diarrhea, and therefore has recalculated the recoverable amount of the intangible asset related to Aemcolo ® . The recoverable amount was determined using discounted cash flow calculations where the asset’s expected post-tax cash flows are risk-adjusted (using WACC) over their estimated remaining useful economic life. The main estimates used in calculating the recoverable amount include size of the potential market, the asset’s peak market share and the period in which it will be reached and the amount and timing of projected future cash flows. See note 11(b). Moreover, the Company determined the asset’s useful economic life, over which the asset will be amortized on a straight-line from its acquisition. The main estimate used in determining the useful life was the anticipated duration of sales of the product after its patent expiration. Estimated useful economic 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 ® as an asset acquisition. 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 Company determined the asset’s useful economic life, over which the asset will be amortized on a straight-line from its acquisition. The main estimate used in determining the useful life was the anticipated duration of sales of the product after its expected patent expiration. |
FINANCIAL INSTRUMENTS AND FINAN
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT | 12 Months Ended |
Dec. 31, 2020 | |
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 an additional expense of $3,000, $12,000, and $58,000 in profit or loss for the years ended December 31, 2020, 2019 and 2018, respectively. 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 will be 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 mainly from cash and cash equivalents and trade receivables. The Company estimates that since the liquid instruments are mainly invested with highly rated institutions, the credit and interest risks associated with these balances are low. 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. An immaterial amount of the trade receivable balance as of December 31, 2020, relates to U.S.-based smaller wholesale customers to whom the Company has only limited history of sales. 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, 2020, and December 31, 2019. (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, deposits and financial assets through profit or loss). This is generally carried out based on the As of December 31, 2020, the Company has generated revenues from commercialization and promotional 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. Balances due within 12 months equal their carrying balances as the impact of discounting is not significant. 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 Contractual maturities of financial liabilities Less than 1 year 2-5 years More than 5 years Total contractual cash flows Carrying amount U.S. Dollars in Thousands Accounts payable 4,184 4,184 4,184 Lease liabilities 1,052 3,117 385 4,554 3,815 Accrued expenses and other current liabilities 5,598 5,598 5,598 Royalty obligation — 394 999 1,393 500 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 15, the Credit Agreement 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, beginning with the fiscal quarter ending June 30, 2022. As of December 31, 2020, the minimum level of cash, which relates to the term loans is $16 million. This amount is presented as restricted cash on the statement of financial position. 3) Fair value estimation The following is an analysis of financial instruments measured at fair value using valuation methods. The different levels have been defined as follows: · quoted prices (unadjusted) in active markets for identical assets or liabilities (level 1); · inputs other than quoted prices included within level 1 that are observable for the asset or liability, either directly (that is, as prices) or indirectly (that is, derived from prices) (level 2); and · inputs for the asset or liability that are not based on observable market data (that is, unobservable inputs) (level 3). The fair value of financial instruments traded in active markets is based on quoted market prices at dates of the Statements of Financial Position. A market is regarded as active if quoted prices are readily and regularly available from an exchange, dealer, broker, industry group, pricing service, or regulatory agency, and those prices represent actual and regularly occurring market transactions on an arm’s length basis. These instruments are included in level 1. The fair value of financial instruments that are not traded in an active market is determined by using valuation techniques. These valuation techniques maximize the use of observable market data where it is available and rely as little as possible on entity-specific estimates. If all significant inputs required to determine the fair value of an instrument are observable, then the instrument is included in level 2. If one or more of the significant inputs is not based on observable market data, the instrument is included in level 3. The following table presents Company assets and liabilities measured at fair value: Level 1 U.S. dollars in thousands December 31, 2020: Assets - Financial assets at fair value through profit or loss 481 December 31, 2019: Assets - Financial assets at fair value through profit or loss 8,500 The carrying amount of cash equivalents, current and non-current bank deposits, receivables, account payables and accrued expenses approximate their fair value due to their short-term characteristics. The fair values of the Borrowing and the Payable in respect of intangible assets purchase balances as of December 31, 2020, are approximately $94 million and $26.6 million. 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, 2020 | |
CASH AND CASH EQUIVALENTS. | |
CASH AND CASH EQUIVALENTS | NOTE 5 - CASH AND CASH EQUIVALENTS: December 31, 2020 2019 U.S. dollars in thousands Cash in bank 14,264 6,471 Short-term bank deposits 15,031 22,552 29,295 29,023 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, 2020 | |
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: These financial assets as of December 31, 2020, represent a portfolio of marketable debt securities. 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, 2020 | |
PREPAID EXPENSES AND OTHER RECEIVABLES | |
PREPAID EXPENSES AND OTHER RECEIVABLES | NOTE 7 - PREPAID EXPENSES AND OTHER RECEIVABLES: December 31, 2020 2019 U.S. dollars in thousands Advance to suppliers 2,543 1,412 Discount from service provider 46 63 Prepaid expenses 2,298 413 Government institutions 634 356 5,521 2,244 The fair value of other receivables, which constitute of financial assets, approximates their carrying amount. |
INVENTORY
INVENTORY | 12 Months Ended |
Dec. 31, 2020 | |
INVENTORY | |
INVENTORY | NOTE 8 - INVENTORY: December 31, 2020 2019 U.S. dollars in thousands Raw materials 1,792 1,590 Finished goods 4,734 292 6,526 1,882 During the years ended December 31, 2020, and 2019, the Company recognized amounts of $5.2 million and $0.9 million, respectively, in inventory cost as part of cost of revenues. Write-downs of inventories to net realizable value amounted to $0.4 million in 2020 and $0.1 million in 2019. These were recognized as an expense, included in cost of revenues in the statement of comprehensive loss. |
FIXED ASSETS
FIXED ASSETS | 12 Months Ended |
Dec. 31, 2020 | |
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 2020 2019 2020 2019 2020 2019 U.S. dollars in thousands Office furniture and equipment (including computers) 753 534 479 324 274 210 Leasehold improvements 357 138 120 120 237 18 1,110 672 599 444 511 228 |
LEASES
LEASES | 12 Months Ended |
Dec. 31, 2020 | |
LEASES | |
LEASES | NOTE 10 - LEASES: Amounts recognized in the Statements of Financial Position: December 31, 2020 December 31, 2019 U.S dollars in thousands Right-of-use assets: Properties 2,593 3,199 Vehicles 2,599 379 5,192 3,578 Lease liabilities: Current 1,710 834 Non-current 3,807 2,981 5,517 3,815 *Additions to the right-of-use assets and lease liabilities during the year ended 2020 and 2019 were $2.9 million and $2.8 million, respectively. Amounts recognized in the Statements of Comprehensive Loss: Year Ended December 31, 2020 Year Ended December 31, 2019 Depreciation charge of right-of-use assets Properties 607 524 Vehicles 948 370 1,555 894 Interest expense (included in financial expenses) 574 390 *Expense relating to short-term leases and expense relating to leases of low-value assets are immaterial. **The total cash outflow for leases in 2020 and 2019 was $2 million and $1 million, respectively. |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 12 Months Ended |
Dec. 31, 2020 | |
INTANGIBLE ASSETS | |
INTANGIBLE ASSETS | NOTE 11 - INTANGIBLE ASSETS: a. The Company’s intangible assets represent in-licenses of R&D assets and Commercialization assets (rights related to Movantik ® and Aemcolo ® ). The changes in those assets are as follows: Year Ended December 31, 2020 2019 U.S. dollars in thousands R&D assets: Cost: Balance at beginning of year 5,355 5,320 Additions during the year 402 35 Amortization charges (50) — Balance at end of year 5,707 5,355 Commercialization assets: Cost: Balance at beginning of year 11,572 — Additions during the year see notes 16(a)(4)-16(a)(6) 77,585 11,788 Amortization and impairment charges see (b) below (6,985) (216) Balance at end of year 82,172 11,572 87,879 16,927 The Company estimated the useful life of assets related to Movantik ® and Aemcolo ® at 10.5 years and 11 years, respectively, from the dates of each asset’s acquisition (April 2020 and October 2019, respectively). Moreover, the Company estimated the useful life of the asset related to Talicia ® at approximately 15 years from its marketing approval date (November 2019). For further details regarding the intangible assets see notes 2h, 3, and 16. b. Intangible assets impairment: Following the outbreak 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 ® , for traveler’s diarrhea, and therefore has recalculated the recoverable amount of the intangible asset related to Aemcolo ® . During the year ended 2020, the Company adjusted the recoverable amount to approximately $9.8 million and recognized an impairment loss of $0.8 million. The significant changes in assumptions are related to an expected decrease in the size of the potential market from 2020 through 2023, as well as a change in the WACC used to discount the asset’s cash flows from 15.4% as of December 31, 2019, to 17.2% as of the date of the recalculation on March 31, 2020. The impairment loss was recognized under Cost of Revenues in the Consolidated Statements of Comprehensive Loss, and it is attributable in full to the Commercial Operations segment. As of December 31, 2020, the Company determined that there is no indication for additional impairment with respect to the Aemcolo ® product and therefore no additional assessment was required for this asset. 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, 2020 | |
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 2020, 2019, and 2018 were $214,000, $184,000, and $182,000, respectively. |
ACCRUED EXPENSES AND OTHER CURR
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | 12 Months Ended |
Dec. 31, 2020 | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | NOTE 13 - ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES: December 31, 2020 2019 U.S. dollars in thousands Accrued expenses 18,972 2,996 Employees and related liabilities 4,963 1,228 Government institutions 147 107 24,082 4,331 |
ALLOWANCE FOR DEDUCTIONS FROM R
ALLOWANCE FOR DEDUCTIONS FROM REVENUES | 12 Months Ended |
Dec. 31, 2020 | |
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, 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, 2020 | |
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 ® from AstraZeneca. 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, The term loans mature in six years with no principal payments required in the first three years. 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 ® , and all of the equity interests in RedHill Inc. The Credit Agreement also restricts the ability of RedHill Inc. to make certain payments, including paying dividends, to the Company prior to the full repayment of the term loan facility. The Credit Agreement contains certain customary affirmative and negative covenants, which were all met as of December 31, 2020. 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, 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, 2020, the minimum level of cash, which relates to the term loans is $16 million. This amount is presented as restricted cash on the 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 are restricted from being exchanged or used to settle a liability for at least twelve months after the reporting period and therefore are presented as non-current assets until 12 months prior to the term loan maturity dates. 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. |
COMMITMENTS
COMMITMENTS | 12 Months Ended |
Dec. 31, 2020 | |
COMMITMENTS | |
COMMITMENTS | NOTE 16 - COMMITMENTS: a. Agreements to purchase intellectual property and commercial products: 1) On August 11, 2010, the Company entered into an agreement with a private 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). In 2014, the Company entered into a licensing agreement with Salix Pharmaceuticals, Ltd., which was later acquired by Valeant Pharmaceuticals International, Inc. and subsequently renamed to Bausch Health Companies Inc. (“Bausch Health”), pursuant to which Bausch Health licensed from the Company the exclusive worldwide rights to one of the above-mentioned therapeutic candidates. Under the license agreement, Bausch Health paid the Company an upfront payment of $7 million, recognized by the Company as revenues in 2014, and as a result, the Company paid the Australian company an amount of $1 million, that were recognized as cost of revenues in the Statements of Comprehensive Loss. In December 2019, the Company terminated the licensing agreement with Bausch Health and regained the exclusive worldwide rights to the therapeutic candidate licensed. Through December 31, 2020, the Company has paid the Australian company in total $1.5 million, as mentioned above. 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, 2020, the Company has paid the German company only the initial amount mentioned above. 3) Following an amendment to the agreement from February 2018, during December 2018, the Company elected to convert the current payment of the remaining $0.5 million into increased future potential royalty payments. As of December 31, 2020, and December 31, 2019, the Company recognized an amount of $0.75 million and $0.5 million, respectively, as a non-current liability with respect to the increase in potential royalty payments. 4) ® and a simultaneous private investment by Cosmo. Under the terms of the license agreement, Cosmo invested $36.3 million in cash and granted the Company the exclusive rights to commercialize Aemcolo ® in the U.S. for travelers’ diarrhea. The license agreement also grants the Company certain rights related to the potential development of additional indications for Aemcolo ® , as well as arrangements related to other pipeline therapeutic candidates of Cosmo. Under the terms of the agreements, the Company issued 5,185,715 ADSs to Cosmo for the cash investment and 1,714,286 ADSs to Cosmo Technologies Ltd, a wholly-owned subsidiary of, as an upfront payment for the U.S commercialization rights granted under the license. In addition, the Company agreed to pay Cosmo a royalty percentage in the high twenties on net sales generated from the commercialization of Aemcolo ® in the U.S. The license agreement further provides for potential regulatory and commercial milestone payments to Cosmo totaling up to $100 million. 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 License Agreement, the Supply Agreement and the TSA became effective. Under the terms of the 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. See note 28 (e) regarding with regard to an amendment to the License Agreement subsequent to December 2020. 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 ® . The Company considers the likelihood of having to pay the milestone payments or increased royalties as negligible. In addition, AstraZeneca transferred on the Effective Date to RedHill Inc. a co-commercialization agreement with Daiichi Sankyo, Inc. (“DSI”) for Movantik ® in the U.S, according to which, RedHill Inc. would share costs and pay sales-based payments to DSI under that agreement. Effective July 1, 2020, RedHill Inc. and DSI replaced this agreement with a new royalty-bearing agreement. See note 16(a)(6) below. On October 6, 2020, the parties amended the License Agreement to grant RedHill Inc. also the exclusive commercialization and development rights to Movantik ® (naloxegol) in Israel. Under its Supply Agreement with AstraZeneca used in connection with its commercialization of Movantik ® , RedHill Inc. undertook an obligation for future purchase of API, bulk tables and finished goods. As of December 31, 2020, the total consideration for such purchase is approximately $25 million. RedHill Inc. expects to purchase the inventory, in the regular course of business, as part of its ongoing commercialization of Movantik ® . Under the terms of the License Agreement, RedHill Inc. assumes responsibility over the Abbreviated New Drug Application litigations initiated by AstraZeneca and Nektar against Apotex, Inc. and Apotex Corp. (together “Apotex”) and against MSN Laboratories (“MSN”) in December 2018 and against Aurobindo Pharma U.S.A (“Aurobindo”) in November 2019, in the United States District Court for the District of Delaware. In the complaints, it is alleged that the generic companies’ versions of Movantik ® , if approved and marketed, would infringe a Movantik ® -related patent set to expire in April 2032 (U.S. Patent No. 9,012,469). There exist other Orange Book-listed patents covering Movantik ® , the last of which to expire is U.S. Patent No. 7,786,133 (expected expiry in September 2028), which have not been challenged by the generic companies. 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 ® as an asset acquisition, that does not constitute a business, for the following considerations: (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 ® . That is, RedHill Inc. does not purchase an in-place manufacturing process nor any specialized equipment required for the manufacturing process, but instead, the purpose of the Supply Agreement is to enable RedHill Inc. to establish its own manufacturing capabilities, whether directly or through a third party, that would also require obtaining relevant regulatory approvals, which presumably will take a significant period of time. (a) 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. (b) 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 estimated at approximately 10.5 years from the Effective Date. 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. The sales-based royalties are expensed as incurred and recognized under Cost of Revenues. 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. The Company determined that AstraZeneca does not control the product before it is transferred to the end customers (the wholesalers) since Redhill Inc. has the significant risks and rewards of holding the product rather than AstraZeneca. In addition, RedHill Inc. is primarily responsible for fulfilling the obligation to provide Movantik ® to customers, including for acceptability. Moreover, RedHill Inc. bears the inventory risk and has discretion over pricing and discounts and AstraZeneca has limited ability in entering into new agreements with customers or changing commercial terms of existing agreements. Therefore, the Company concluded that RedHill Inc. is a principal in providing Movantik ® during the SOTC period, and it 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 shall be expensed as incurred. Starting October 1, 2020, AstraZeneca no longer provided the abovementioned services. 6) As described in note 16a(5) above, as part of the Movantik ® transaction, the Company undertook the pre-existing co-commercialization agreement with DSI, under which the Company and DSI share certain costs while paying DSI a significant share from its sales volume of 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 in December 2021 and $5 million 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 16a(5) above and shall be amortized on a straight-line basis over its useful life. b. Payroll Protection Program: In April 2020, RedHill Inc. received a loan of approximately $2.3 million under the U.S. Small Business Administration Payroll Protection Program (“PPP”) which was created under the Coronavirus Aid, Relief and Economic Security Act. The loan has a term of two years and bears a fixed interest rate of 1% per annum, with the initial six months of interest deferred. Under the PPP, repayment of the loan, including interest, may be forgiven based on payroll expenses, rent, utilities and other qualifying expenses incurred in the eight weeks following receipt of the loan, provided that RedHill Inc. will adhere to specific requirements outlined in the PPP. The Company estimates that there is reasonable assurance that RedHill Inc. will comply with the conditions associated with forgiveness of the loan and that the loan will be forgiven, and therefore accounted for the PPP loan as a government grant, recognizing it in the statements of comprehensive loss, as a reduction of sales and marketing and general and administration expenses. |
INCOME TAX
INCOME TAX | 12 Months Ended |
Dec. 31, 2020 | |
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 for 2020, 2019, and 2018 were 23%. b. U.S. subsidiary: The Company’s subsidiary is incorporated in the U.S and is taxed under U.S. tax laws. The applicable corporate tax rates is 21% since 2018 and thereafter. 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, 2020, the Company had net operating loss (“NOLs”) carried forward of approximately $190 million. Under Israeli tax laws, carryforward tax losses have no expiration date. As of December 31, 2020, the U.S. subsidiary had a net operating loss carryforward of approximately $64 million, of which approximately $10 million expires in 2037, and approximately $54 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, 2020, and 2019, were $12 million and $17 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 2015 are therefore considered final. |
SHARE CAPITAL
SHARE CAPITAL | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 2019 In thousands Authorized ordinary shares 794,000 594,000 Authorized preferred shares (reserved) 6,000 6,000 Issued and paid ordinary shares 383,981 352,696 In May 2018, a general meeting of the Company’s shareholders approved the increase of the authorized share capital of the Company to 600,000,000 ordinary shares. In June 2019, a general meeting of the Company’s shareholders approved to amend the Company's registered share capital into (i) 594,000,000 ordinary shares, par value NIS 0.01 each, and (ii) 6,000,000 preferred shares, par value NIS 0.01 each. 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 ordinary 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 per share. b . During 2020, the Company sold 2,837,038 ADSs under an “at-the-market” equity offering program (“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. The sales are under the Company's sales agreement with SVB Leerink LLC (“Leerink”) which provides that, upon the terms and subject to the conditions and limitations in the sales agreement, the Company may elect from time to time, to offer and sell its ADSs having aggregate gross sales proceeds of up to $60 million through the ATM program, under which Leerink acts as the sales agent. The issuance and sale of ADSs by the Company under the ATM program are being made pursuant to the Company’s shelf registration statement declared effective on July 31, 2018. c. During 2020 and 2019, the Company issued 8,156 ADSs and 8,750 ordinary shares for $52,000 and $5,000, respectively, resulting from exercises of options that had been issued to employees, of the Company. d. In July 2020, as part of the transaction described in note 16a(6) above, the Company entered into a security purchase agreement with DSI and subsequently issued to DSI 283,387 ADSs for approximately $2 million. e. In October 2019, the Company, under the strategic collaboration discussed in note 16(a)(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 ® . f . In December 2018, the Company completed an underwritten offering in the U.S. of an aggregate of 2,857,143 ADSs for gross proceeds to the Company of approximately $20 million. Net proceeds to the Company from the offering, following underwriting commissions and other offering expenses, were approximately $18.4 million. g . In August 2018, the Company completed an underwritten offering in the U.S. of an aggregate of 4,166,667 ADSs for gross proceeds to the Company of approximately $25 million. Net proceeds to the Company from the offering, following underwriting commissions and other offering expenses, were approximately $23.5 million. |
SHARE-BASED PAYMENTS
SHARE-BASED PAYMENTS | 12 Months Ended |
Dec. 31, 2020 | |
SHARE-BASED PAYMENTS | |
SHARE-BASED PAYMENTS | NOTE 19 - SHARE-BASED PAYMENTS: On May 30, 2010, a general meeting of shareholders approved the option plan of the Company (the “Option Plan”), after being approved by the BoD. In 2017 the Option Plan was amended and restated as the 2010 Award Plan (the “Award Plan”). As of December 31, 2020, the Award Plan allows the Company to allocate up to 59,206,448 options to purchase ordinary shares to employees, consultants, and directors and are reserved by the BoD for issuance under the Award Plan. The terms and conditions of the grants were determined by the BoD and are according to the Award Plan. a. The following is information on options granted in 2020: Number of options granted in ADSs According to the Award Plan Exercise Fair value of of the Company price for 1 options on date of Other than to ADS ($) grant in U.S. dollars Date of grant directors (1) To directors (1)(2) Total in thousands (3) January 2020 95,000 — 95,000 6.60 243 February 2020 52,500 — 52,500 6.05 119 March 2020 285,000 144,000 429,000 4.87 970 May 2020 143,000 75,000 218,000 7.50 831 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 are exercisable into the Company’s ADSs. 2) The general meeting of the Company’s shareholders held on May 4, 2020 (the “May 2020 AGM”), 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. b. The following is information on options granted in 2019: Number of options granted in ADSs 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 (3) February 2019 158,000 — 158,000 8.90 628 May 2019 564,000 — 564,000 9.20 2,433 June 2019 — 187,500 187,500 9.20 641 July 2019 43,500 — 43,500 8.00 173 September 2019 35,000 35,000 8.00 150 November 2019 60,000 60,000 7.60 195 December 2019 137,000 137,000 6.90 451 997,500 187,500 1,185,000 4,671 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 June 24, 2019 (the “June 2019 AGM”), subsequent to approval of the Company’s BoD, granted 187,500 options under the Company’s Award Plan, to the Company’s directors and to the 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 ordinary share: $6.1 - $8.3 expected volatility: 57.48% - 58.27%, risk-free interest rate: 1.63% - 2.67% and the expected term was derived based on the contractual term of the options, the expected exercise behavior and expected post-vesting forfeiture rates. the expected volatility assumption used based on the historical volatility of the Company’s ordinary share. c. Changes in the number of options in ADSs and weighted averages of exercise prices are as follows: Year Ended December 31, 2020 2019 Weighted Weighted average of average of Number of exercise Number of exercise options price ($) options price ($) Outstanding at beginning of year 4,050,898 10. 3 2,936,024 10.50 Exercised (8,156) 6.38 (875) 6.10 Expired and forfeited (264,939) 9.65 (69,250) 10.30 Granted 1,651,000 6.90 1,185,000 8.70 Outstanding at end of year 5,428,803 9.08 4,050,898 10.3 Exercisable at end of year 3,178,317 10.19 2,490,292 11.40 d. The following is information about the exercise price and remaining useful life of outstanding options at year-end: Year Ended December 31, 2020 2019 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 5,428,803 $5.6-$16.1 5.9 4,050,898 $5.6-$16.1 5.2 e. Expenses recognized in profit or loss for the options are as follows: Year Ended December 31, 2020 2019 2018 U.S. dollars in thousands 3,027 2,678 The remaining compensation expenses as of December 31, 2020, are $4.5 million and will be expensed in full by September 2024. |
NET REVENUES
NET REVENUES | 12 Months Ended |
Dec. 31, 2020 | |
NET REVENUES | |
NET REVENUES | NOTE 20 - NET REVENUES: Year Ended December 31, 2020 2019 2018 U.S dollars in thousands Movantik ® revenues 59,356 — — Other revenues (1) 5,003 6,291 8,360 64,359 6,291 8,360 1) D uring the years 2019 and 2018, $3.1 million and $3.7 million, respectively, were attributed to the promotional services, and $3.2 million and $4.7 million, respectively, 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, 2020 | |
RESEARCH AND DEVELOPMENT EXPENSES. | |
RESEARCH AND DEVELOPMENT EXPENSES | NOTE 21 - RESEARCH AND DEVELOPMENT EXPENSES: Year Ended December 31, 2020 2019 2018 U.S. dollars in thousands Payroll and related expenses 636 623 552 Professional services and consulting fees 1,752 2,345 2,297 Share-based payments 883 671 872 Clinical and pre-clinical trials 12,569 12,840 20,373 Intellectual property development 298 317 290 Other 353 623 478 16,491 17,419 24,862 |
SELLING, MARKETING AND BUSINESS
SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES | 12 Months Ended |
Dec. 31, 2020 | |
SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES | |
SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES | NOTE 22 - SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES: Year Ended December 31, 2020 2019 2018 U.S. dollars in thousands Payroll and related expenses 20,756 9,335 7,540 Share-based payments 1,464 941 575 Professional services 18,957 3,680 1,626 Samples 438 178 — Travel, fleet, meals and related expenses 5,729 2,193 1,822 Office-related expenses 957 789 495 Other 984 1,217 428 49,285 18,333 12,486 |
GENERAL AND ADMINISTRATIVE EXPE
GENERAL AND ADMINISTRATIVE EXPENSES | 12 Months Ended |
Dec. 31, 2020 | |
GENERAL AND ADMINISTRATIVE EXPENSES | |
GENERAL AND ADMINISTRATIVE EXPENSES | NOTE 23 - GENERAL AND ADMINISTRATIVE EXPENSES: Year Ended December 31, 2020 2019 2018 U.S. dollars in thousands Payroll and related expenses 11,159 4,903 3,880 Share-based payments 1,855 1,415 1,231 Professional services 9,132 3,479 1,461 Medical affairs 1,052 299 — Office-related expenses 1,168 585 547 Other 1,009 800 387 25,375 11,481 7,506 |
FINANCIAL (INCOME) EXPENSES, ne
FINANCIAL (INCOME) EXPENSES, net | 12 Months Ended |
Dec. 31, 2020 | |
FINANCIAL (INCOME) EXPENSES, net | |
FINANCIAL (INCOME) EXPENSES, net | NOTE 24 - FINANCIAL (INCOME) EXPENSES, net: Year Ended December 31, 2020 2019 2018 U.S dollars in thousands Financial income: Fair value gains on derivative financial instruments — 344 104 Gains on financial assets at fair value through profit or loss 94 474 295 Gains from changes in exchange rates — 74 — Interest from bank deposits 176 443 279 270 1,335 678 Financial expenses: Interest and finance charges for lease liabilities 405 390 — Loss from changes in exchange rates 9 — 125 Interest expenses related to borrowing and payable in respect of intangible assets purchase 12,045 — — Other 300 48 42 12,759 438 167 Financial (income) /expenses, net 12,489 (897) (511) ( |
SEGMENT INFORMATION
SEGMENT INFORMATION | 12 Months Ended |
Dec. 31, 2020 | |
SEGMENT INFORMATION | |
SEGMENT INFORMATION | NOTE 25 - SEGMENT INFORMATION: The Company has two segments, Commercial Operations and Research & Development. In line with the reporting to the Chief Executive Officer, the performance of these segments is reviewed at revenues, gross profit, and operating expenses levels. The Commercial Operations segment covers all areas relating to the commercial sales and operating expenses directly related to that activity and is being performed by the Company’s U.S. subsidiary. The Research and Development segment includes all activities related to the research and development of therapeutic candidates and is being performed by the Company. There is no segmentation of the Statements of Financial Position. Charges such as depreciation, impairment and other non-cash expenses are charged to the relevant segment. a. Segment information Year Ended December 31, 2020 December 31, 2020: Commercial Operations Research and Development Consolidated U.S. dollars in thousands Net revenues 64,359 — 64,359 Cost of revenues 36,892 — 36,892 Gross profit 27,467 — 27,467 Research and development expenses, net — 16,491 16,491 Selling, marketing, and business development expenses 47,468 1,817 49,285 General and administrative expenses 17,597 7,778 25,375 Operating loss 37,598 26,086 63,684 Year Ended December 31, 2019 Commercial Operations Research and Development Consolidated U.S. dollars in thousands Net revenues 6,291 — 6,291 Cost of revenues 2,259 — 2,259 Gross profit 4,032 — 4,032 Research and development expenses, net — 17,419 17,419 Selling, marketing, and business development expenses 16,854 1,479 18,333 General and administrative expenses 5,173 6,308 11,481 Operating loss 17,995 25,206 43,201 Year Ended December 31, 2018 Commercial Operations Research and Development Consolidated U.S. dollars in thousands Net revenues 8,360 — 8,360 Cost of revenues 2,837 — 2,837 Gross profit 5,523 — 5,523 Research and development expenses, net — 24,862 24,862 Selling, marketing, and business development expenses 11,329 1,157 12,486 General and administrative expenses 2,795 4,711 7,506 Operating loss 8,601 30,730 39,331 b. Major customers The following table represent the percentages of total net revenues from the major customers: Year Ended December 31, 2020 2019 2018 Customer A 35% Customer B 28% Customer C 35% 10% Customer D 45% 42% Customer E 18% 46% 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, 2020, amount to $7.5 million (mainly Intangible assets- $5.7 million and Right-of-use assets - $1.4 million). The remainder of the consolidated non-current assets as of December 31, 2020 , equal to $102.3 million, are located in the U.S (consisting mainly of Intangible assets- $82.2 million, Restricted Cash - $16 million and Right-of-use assets - $3.8 million). |
LOSS PER ORDINARY SHARE
LOSS PER ORDINARY SHARE | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 2019 2018 Loss (U.S. dollars in thousands) 76,173 42,304 38,820 Weighted average number of ordinary shares outstanding during the period (in thousands) 364,276 296,922 231,204 Basic loss per share (U.S. dollars) 0.21 0.14 0.17 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, 2020 | |
RELATED PARTIES | |
RELATED PARTIES | NOTE 27 - RELATED PARTIES: a. Key management in 2020 includes members of the Board of Directors, including the Company’s Chief Commercial Officer and Chief Executive Officer: Year Ended December 31, 2020 2019 2018 U.S. dollars in thousands Key management compensation: Salaries and other short-term employee benefits 1,526 876 734 Post-employment benefits 61 43 36 Share-based payments 710 468 510 Other long-term benefits 33 26 26 b. Balances with related parties: December 31, 2020 2019 U.S. dollars in thousand Current liabilities - Credit balance in “accrued expenses and other current liabilities” 484 175 |
EVENTS SUBSEQUENT TO DECEMBER 3
EVENTS SUBSEQUENT TO DECEMBER 31, 2020 | 12 Months Ended |
Dec. 31, 2020 | |
EVENTS SUBSEQUENT TO DECEMBER 31, 2020 | |
EVENTS SUBSEQUENT TO DECEMBER 31, 2020 | NOTE 28 - EVENTS SUBSEQUENT TO DECEMBER 31, 2020: a. In January 2021, the Company completed an underwritten bought deal offering of 3,188,776 ADSs for gross proceeds to the Company of approximately $25 million. Net proceeds to the Company from the offering, following underwriting commissions and other offering expenses, were approximately $23.1 million. b. In March 2021, the Company completed an underwritten bought deal offering of 4,647,433 ADSs for gross proceeds to the Company of approximately $37 million. Net proceeds to the Company from the offering, following underwriting commissions and other offering expenses, were approximately $34.8 million. c. During 2021 the Company issued 428,421 ADSs for $3.5 million, resulting from exercises of options that had been issued to employees, consultants, and the Chief Executive Officer of the Company. d. On February 22, 2021, Aether Therapeutics Inc., filed a complaint against the Company in the United States District Court for the District of Delaware ("Aether Litigation"). The complaint asserts that the Company's marketing of the Movantik ® product infringes U.S. Patent Nos. 6,713,488, 8,748,448, 8,883,817 and 9,061,024 held by Aether Therapeutics Inc., or the Aether Patents. Aether has asserted the Aether Patents against other entities previously involved in the marketing of the Movantik ® product. The complaint requests customary remedies for patent infringement, including (i) a judgment that the Company has infringed, contributed to and induced infringement of the Aether patents, (ii) damages, (iii) attorneys’ fees and (iv) costs and expenses. the Company intends to vigorously defend itself against these claims. Given the early stage of the Aether Litigation, the Company is unable to predict the likelihood of success of the claims of Aether Therapeutics Inc. or to quantify any risk of loss. e. On March 11, 2021, RedHill Inc and AstraZeneca signed an amendment to the License Agreement. Pursuant to the amendment, the $15.5 million payment due in December 2021 and contemplated in note 16(a)(5) will be adjusted to gradual payments starting in March 2021 and ending in December 2022, totaling $16 million. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Basis for presentation of the financial statements | a. Basis for presentation of the financial statements The consolidated financial statements of the Company have been prepared in accordance with International Financial Reporting Standards (“IFRS”), as issued by the International Accounting Standards Board (“IASB”). The significant accounting policies described below have been applied consistently in relation to all the periods presented, unless otherwise stated. The consolidated financial statements have been prepared under the historical cost convention, subject to adjustments in respect of revaluation of financial assets and financial liabilities at fair value through profit or loss. The preparation of financial statements in conformity with IFRS requires the use of certain critical accounting estimates. It also requires management to exercise its judgment in applying the Company’s accounting policies. The areas involving a higher degree of judgment or complexity, or areas where assumptions and estimates are significant to the financial statements, are disclosed in note 3. Actual results could differ significantly from those estimates and assumptions. |
Translation of foreign currency transactions and balances | b. Translation of foreign currency transactions and balances 1) Functional and presentation currency Items included in the consolidated financial statements are measured using the currency of the primary economic environment in which the Company and its subsidiary operate (the “Functional Currency”). The consolidated financial statements are presented in U.S. dollars (“$”), 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 (“EUR”) 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 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 for approved products Commercialization assets"). R&D assets are stated at cost and are not amortized. These assets are tested for impairment at least annually. At the time these assets will be available for use, they will be amortized over their useful lives. Commercialization assets are stated at cost and are amortized on a straight-line basis over their useful economic life when they are available for use. These assets are subsequently carried at cost less accumulated amortization and impairment losses. In determining the useful economic life of a commercialization asset, the Company considered, among other factors, the duration of the license, patent and regulatory data exclusivities of the product, anticipated duration of sales of the product following loss of exclusivity, and competitors in the marketplace. 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). |
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 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 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) Recognition and measurement 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) Impairment 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’s ordinary shares are classified as the Company’s share capital. Incremental costs directly attributed to the issuance of new shares or warrants are presented under equity as a deduction from the proceeds of issuance. |
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(a)(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 . The Company offers discounts to its customers, as an incentive for prompt payment. The Company records these discounts as a reduction of revenue in the period the related revenue from the sale of products is recognized. In addition, distribution fees are paid to certain distributors based on contractually determined rates from the gross consideration. As the fee paid to the customer is not for a distinct good or service, it is recognized as a reduction of revenue in the period the related revenue from the sale of products is recognized. Rebates and patient discount programs. The Company offers various rebate and patient discount programs, which result in discounted prescriptions to qualified patients. The Company estimates the allowance for these rebates and coupons based on historical and estimated utilization of the rebate and discount programs, at the time the revenues are recognized. These estimates are recognized as a reduction of revenue. Product returns. The Company offers customers a right of return. The Company estimates the amount of product sales that may be returned by its customers and records this estimate as a reduction of revenue at the time of sale, based on historical rates of return, or, if such historical data is not available, the Company estimates product returns based on its own sales information, its visibility into the inventory remaining in the distribution channel and product dating. At the end of each reporting period, the Company may decide to constrain revenue for product returns based on information from various sources. Principal versus agent considerations . When a third party is involved in providing goods or services to a customer, the Company analyzes whether the Company acts as a principal or an agent in the transaction, based on whether the Company obtains control of the product before it is transferred to the customer, using the indicators provided in IFRS 15, including: primary responsibility for fulfilling the promise to provide the products to its customers, inventory risk before and after transfer to the customers and discretion in establishing the selling price of each product. When determined to be the principal in the arrangements, the Company recognizes revenues in the gross amount it expects to be entitled in exchange for the products transferred to the customers. 2) Revenue from promotional services In 2020, the Company terminated the promotional agreements and recognized immaterial revenues from promotional services. In 2019 and 2018, 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 samples of the commercialized products. These costs are recognized as an expense when incurred. |
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 a) The Company has adopted IFRS 16 retrospectively from January 1, 2019, but has not restated comparatives for the 2018 reporting period, as permitted under the specific transitional provisions in the standard. The reclassifications and the adjustments arising from the new leasing rules are therefore recognized in the statement of financial position at the date of initial application. On adoption of IFRS 16, the Company recognized lease liabilities in relation to leases that had previously been classified as ‘operating leases’ under the principles of IAS 17 “Leases.” These liabilities were measured at the present value of the remaining lease payments, discounted using the lessee’s incremental borrowing rate as of January 1, 2019. The weighted average lessee’s incremental annual borrowing rate applied to the lease liabilities on January 1, 2019, was 6.9%. The associated right-of-use assets were measured at the amount equal to the lease liability and as a result, there was no impact on accumulated deficit on January 1, 2019. In applying IFRS 16 for the first time, the Company has used the following practical expedient permitted by the standard - the accounting for operating leases with a remaining lease term of less than 12 months as of January 1, 2019, as short-term leases. The Company has also elected not to reassess whether a contract is or contains a lease at the date of initial application. Instead, for contracts entered into before the transition date, the Company relied on its assessment made applying IAS 17 and IFRIC 4 determining whether an arrangement contains a lease. b) 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. Until the 2018 financial year, the leases of offices and cars by the Company and its subsidiary were classified as operating leases and payments made were charged to profit or loss on a straight-line basis over the period of the lease. |
Recently adopted pronouncements | s . Recently adopted pronouncements Amendments to IFRS 3 'business combinations' - Definition of a Business ("the amendment"). The amended definition of a business requires an acquisition to include an input and a substantive process that together significantly contribute to the ability to create outputs. The definition of the term ‘outputs’ is amended to focus on goods and services provided to customers, generating investment income and other income, and it excludes returns in the form of lower costs and other economic benefits. The amendment also provides an optional test - the concentration test. If substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or a group of similar identifiable assets, then the acquired set of assets and activities are not considered a business. The Company applied the amendment to IFRS 3 prospectively as from January 1, 2020. See also note 16a(5) for the acquisition of Movantik ® . |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 | |
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT | |
Schedule of company's financial liabilities and estimated maturities | 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 Contractual maturities of financial liabilities Less than 1 year 2-5 years More than 5 years Total contractual cash flows Carrying amount U.S. Dollars in Thousands Accounts payable 4,184 4,184 4,184 Lease liabilities 1,052 3,117 385 4,554 3,815 Accrued expenses and other current liabilities 5,598 5,598 5,598 Royalty obligation — 394 999 1,393 500 |
Schedule of assets and liabilities measured at fair value | Level 1 U.S. dollars in thousands December 31, 2020: Assets - Financial assets at fair value through profit or loss 481 December 31, 2019: Assets - Financial assets at fair value through profit or loss 8,500 |
CASH AND CASH EQUIVALENTS (Tabl
CASH AND CASH EQUIVALENTS (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
CASH AND CASH EQUIVALENTS. | |
Schedule of cash and cash equivalents | December 31, 2020 2019 U.S. dollars in thousands Cash in bank 14,264 6,471 Short-term bank deposits 15,031 22,552 29,295 29,023 |
PREPAID EXPENSES AND OTHER RE_2
PREPAID EXPENSES AND OTHER RECEIVABLES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
PREPAID EXPENSES AND OTHER RECEIVABLES | |
Schedule of prepaid expenses and other receivables | December 31, 2020 2019 U.S. dollars in thousands Advance to suppliers 2,543 1,412 Discount from service provider 46 63 Prepaid expenses 2,298 413 Government institutions 634 356 5,521 2,244 |
INVENTORY (Tables)
INVENTORY (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
INVENTORY | |
Schedule of Inventory | December 31, 2020 2019 U.S. dollars in thousands Raw materials 1,792 1,590 Finished goods 4,734 292 6,526 1,882 |
FIXED ASSETS (Tables)
FIXED ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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 2020 2019 2020 2019 2020 2019 U.S. dollars in thousands Office furniture and equipment (including computers) 753 534 479 324 274 210 Leasehold improvements 357 138 120 120 237 18 1,110 672 599 444 511 228 |
LEASES (Tables)
LEASES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
GENERAL | |
Schedule of amounts recognized for leases | December 31, 2020 December 31, 2019 U.S dollars in thousands Right-of-use assets: Properties 2,593 3,199 Vehicles 2,599 379 5,192 3,578 Lease liabilities: Current 1,710 834 Non-current 3,807 2,981 5,517 3,815 *Additions to the right-of-use assets and lease liabilities during the year ended 2020 and 2019 were $2.9 million and $2.8 million, respectively. Amounts recognized in the Statements of Comprehensive Loss: Year Ended December 31, 2020 Year Ended December 31, 2019 Depreciation charge of right-of-use assets Properties 607 524 Vehicles 948 370 1,555 894 Interest expense (included in financial expenses) 574 390 *Expense relating to short-term leases and expense relating to leases of low-value assets are immaterial. **The total cash outflow for leases in 2020 and 2019 was $2 million and $1 million, respectively. |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
INTANGIBLE ASSETS | |
Schedule of intangible assets changes | Year Ended December 31, 2020 2019 U.S. dollars in thousands R&D assets: Cost: Balance at beginning of year 5,355 5,320 Additions during the year 402 35 Amortization charges (50) — Balance at end of year 5,707 5,355 Commercialization assets: Cost: Balance at beginning of year 11,572 — Additions during the year see notes 16(a)(4)-16(a)(6) 77,585 11,788 Amortization and impairment charges see (b) below (6,985) (216) Balance at end of year 82,172 11,572 87,879 16,927 |
ACCRUED EXPENSES AND OTHER CU_2
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | |
Schedule of accrued expenses and other current liabilities | December 31, 2020 2019 U.S. dollars in thousands Accrued expenses 18,972 2,996 Employees and related liabilities 4,963 1,228 Government institutions 147 107 24,082 4,331 |
ALLOWANCE FOR DEDUCTIONS FROM_2
ALLOWANCE FOR DEDUCTIONS FROM REVENUES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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, 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 |
SHARE CAPITAL (Tables)
SHARE CAPITAL (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
SHARE CAPITAL | |
Schedule of composition of share capital | Number of shares December 31, 2020 2019 In thousands Authorized ordinary shares 794,000 594,000 Authorized preferred shares (reserved) 6,000 6,000 Issued and paid ordinary shares 383,981 352,696 |
SHARE-BASED PAYMENTS (Tables)
SHARE-BASED PAYMENTS (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
SHARE-BASED PAYMENTS | |
Schedule of information on options granted | a. The following is information on options granted in 2020: Number of options granted in ADSs 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 (3) January 2020 95,000 — 95,000 6.60 243 February 2020 52,500 — 52,500 6.05 119 March 2020 285,000 144,000 429,000 4.87 970 May 2020 143,000 75,000 218,000 7.50 831 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 are exercisable into the Company’s ADSs. 2) The general meeting of the Company’s shareholders held on May 4, 2020 (the “May 2020 AGM”), 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. b. The following is information on options granted in 2019: Number of options granted in ADSs 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 (3) February 2019 158,000 — 158,000 8.90 628 May 2019 564,000 — 564,000 9.20 2,433 June 2019 — 187,500 187,500 9.20 641 July 2019 43,500 — 43,500 8.00 173 September 2019 35,000 35,000 8.00 150 November 2019 60,000 60,000 7.60 195 December 2019 137,000 137,000 6.90 451 997,500 187,500 1,185,000 4,671 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 June 24, 2019 (the “June 2019 AGM”), subsequent to approval of the Company’s BoD, granted 187,500 options under the Company’s Award Plan, to the Company’s directors and to the 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 ordinary share: $6.1 - $8.3 expected volatility: 57.48% - 58.27%, risk-free interest rate: 1.63% - 2.67% and the expected term was derived based on the contractual term of the options, the expected exercise behavior and expected post-vesting forfeiture rates. the expected volatility assumption used based on the historical volatility of the Company’s ordinary share. |
Schedule of number of shares and weighted averages of exercise prices | Year Ended December 31, 2020 2019 Weighted Weighted average of average of Number of exercise Number of exercise options price ($) options price ($) Outstanding at beginning of year 4,050,898 10. 3 2,936,024 10.50 Exercised (8,156) 6.38 (875) 6.10 Expired and forfeited (264,939) 9.65 (69,250) 10.30 Granted 1,651,000 6.90 1,185,000 8.70 Outstanding at end of year 5,428,803 9.08 4,050,898 10.3 Exercisable at end of year 3,178,317 10.19 2,490,292 11.40 |
Schedule of information about exercise price and remaining useful life of outstanding options | Year Ended December 31, 2020 2019 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 5,428,803 $5.6-$16.1 5.9 4,050,898 $5.6-$16.1 5.2 |
Schedule of expenses recognized in profit or loss | Year Ended December 31, 2020 2019 2018 U.S. dollars in thousands 3,027 2,678 |
NET REVENUES (Tables)
NET REVENUES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
NET REVENUES | |
Schedule of net revenues | Year Ended December 31, 2020 2019 2018 U.S dollars in thousands Movantik ® revenues 59,356 — — Other revenues (1) 5,003 6,291 8,360 64,359 6,291 8,360 |
RESEARCH AND DEVELOPMENT EXPE_2
RESEARCH AND DEVELOPMENT EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
RESEARCH AND DEVELOPMENT EXPENSES. | |
Schedule of research and development expenses | Year Ended December 31, 2020 2019 2018 U.S. dollars in thousands Payroll and related expenses 636 623 552 Professional services and consulting fees 1,752 2,345 2,297 Share-based payments 883 671 872 Clinical and pre-clinical trials 12,569 12,840 20,373 Intellectual property development 298 317 290 Other 353 623 478 16,491 17,419 24,862 |
SELLING, MARKETING AND BUSINE_2
SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES | |
Schedule of selling, marketing and business development expenses | Year Ended December 31, 2020 2019 2018 U.S. dollars in thousands Payroll and related expenses 20,756 9,335 7,540 Share-based payments 1,464 941 575 Professional services 18,957 3,680 1,626 Samples 438 178 — Travel, fleet, meals and related expenses 5,729 2,193 1,822 Office-related expenses 957 789 495 Other 984 1,217 428 49,285 18,333 12,486 |
GENERAL AND ADMINISTRATIVE EX_2
GENERAL AND ADMINISTRATIVE EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
GENERAL AND ADMINISTRATIVE EXPENSES | |
Schedule of general and administrative expenses | Year Ended December 31, 2020 2019 2018 U.S. dollars in thousands Payroll and related expenses 11,159 4,903 3,880 Share-based payments 1,855 1,415 1,231 Professional services 9,132 3,479 1,461 Medical affairs 1,052 299 — Office-related expenses 1,168 585 547 Other 1,009 800 387 25,375 11,481 7,506 |
FINANCIAL (INCOME) EXPENSES, _2
FINANCIAL (INCOME) EXPENSES, net (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
FINANCIAL (INCOME) EXPENSES, net | |
Schedule of financial income, net | Year Ended December 31, 2020 2019 2018 U.S dollars in thousands Financial income: Fair value gains on derivative financial instruments — 344 104 Gains on financial assets at fair value through profit or loss 94 474 295 Gains from changes in exchange rates — 74 — Interest from bank deposits 176 443 279 270 1,335 678 Financial expenses: Interest and finance charges for lease liabilities 405 390 — Loss from changes in exchange rates 9 — 125 Interest expenses related to borrowing and payable in respect of intangible assets purchase 12,045 — — Other 300 48 42 12,759 438 167 Financial (income) /expenses, net 12,489 (897) (511) |
SEGMENT INFORMATION (Tables)
SEGMENT INFORMATION (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
SEGMENT INFORMATION | |
Schedule of segment information | Year Ended December 31, 2020 December 31, 2020: Commercial Operations Research and Development Consolidated U.S. dollars in thousands Net revenues 64,359 — 64,359 Cost of revenues 36,892 — 36,892 Gross profit 27,467 — 27,467 Research and development expenses, net — 16,491 16,491 Selling, marketing, and business development expenses 47,468 1,817 49,285 General and administrative expenses 17,597 7,778 25,375 Operating loss 37,598 26,086 63,684 Year Ended December 31, 2019 Commercial Operations Research and Development Consolidated U.S. dollars in thousands Net revenues 6,291 — 6,291 Cost of revenues 2,259 — 2,259 Gross profit 4,032 — 4,032 Research and development expenses, net — 17,419 17,419 Selling, marketing, and business development expenses 16,854 1,479 18,333 General and administrative expenses 5,173 6,308 11,481 Operating loss 17,995 25,206 43,201 Year Ended December 31, 2018 Commercial Operations Research and Development Consolidated U.S. dollars in thousands Net revenues 8,360 — 8,360 Cost of revenues 2,837 — 2,837 Gross profit 5,523 — 5,523 Research and development expenses, net — 24,862 24,862 Selling, marketing, and business development expenses 11,329 1,157 12,486 General and administrative expenses 2,795 4,711 7,506 Operating loss 8,601 30,730 39,331 |
Schedule of percentages of total net revenues from major customers | Year Ended December 31, 2020 2019 2018 Customer A 35% Customer B 28% Customer C 35% 10% Customer D 45% 42% Customer E 18% 46% |
LOSS PER ORDINARY SHARE (Tables
LOSS PER ORDINARY SHARE (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
LOSS PER ORDINARY SHARE | |
Schedule of basic loss per share | Year Ended December 31, 2020 2019 2018 Loss (U.S. dollars in thousands) 76,173 42,304 38,820 Weighted average number of ordinary shares outstanding during the period (in thousands) 364,276 296,922 231,204 Basic loss per share (U.S. dollars) 0.21 0.14 0.17 |
RELATED PARTIES (Tables)
RELATED PARTIES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
RELATED PARTIES | |
Schedule of key management compensation: | Year Ended December 31, 2020 2019 2018 U.S. dollars in thousands Key management compensation: Salaries and other short-term employee benefits 1,526 876 734 Post-employment benefits 61 43 36 Share-based payments 710 468 510 Other long-term benefits 33 26 26 |
Schedule of balances with related parties | December 31, 2020 2019 U.S. dollars in thousand Current liabilities - Credit balance in “accrued expenses and other current liabilities” 484 175 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) | 12 Months Ended | |
Dec. 31, 2020 | Jan. 01, 2019 | |
IFRS 16 | ||
IFRS 16 | ||
Weighted average lessee’s incremental annual borrowing rate applied to the lease liabilities | 6.90% | |
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) | Dec. 31, 2020USD ($) |
Weighted average cost of capital | |
Disclosure of significant unobservable inputs used in fair value measurement of assets [line items] | |
Significant unobservable input | 17 |
FINANCIAL INSTRUMENTS AND FIN_3
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Financial instruments | |||
Percentage of currency stronger against the NIS | 5.00% | 5.00% | 5.00% |
Additional expense that would have been recognized | $ 3,000 | $ 12,000 | $ 58,000 |
Fair value of borrowing | 94,000,000 | ||
Payable in respect of intangible assets purchase balances | $ 26,600,000 | ||
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 [member] | Floating rate | Minimum | |||
Financial instruments | |||
Spread rate | 1.75% | ||
Interest rate risk [member] | Fixed rate | |||
Financial instruments | |||
Borrowings, interest rate | 8.20% | ||
Interest rate risk [member] | 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 ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Financial instruments | ||
Financial liabilities | $ 11,553 | |
Restricted cash | 16,164 | $ 152 |
Cost | ||
Financial instruments | ||
Financial liabilities | 11,553 | |
Minimum | HCRM | ||
Financial instruments | ||
Restricted cash | 16,000 | |
Less than 1 year | ||
Financial instruments | ||
Financial liabilities | 11,553 | |
Accounts payable | ||
Financial instruments | ||
Financial liabilities | 4,184 | |
Accounts payable | Cost | ||
Financial instruments | ||
Financial liabilities | 4,184 | |
Accounts payable | Less than 1 year | ||
Financial instruments | ||
Financial liabilities | 4,184 | |
Lease liabilities | ||
Financial instruments | ||
Financial liabilities | 6,195 | 4,554 |
Lease liabilities | Cost | ||
Financial instruments | ||
Financial liabilities | 5,517 | 3,815 |
Lease liabilities | Less than 1 year | ||
Financial instruments | ||
Financial liabilities | 1,985 | 1,052 |
Lease liabilities | 2-5 years | ||
Financial instruments | ||
Financial liabilities | 4,210 | 3,117 |
Lease liabilities | More than five years | ||
Financial instruments | ||
Financial liabilities | 385 | |
Accrued expenses and other current liabilities | ||
Financial instruments | ||
Financial liabilities | 24,082 | 5,598 |
Accrued expenses and other current liabilities | Cost | ||
Financial instruments | ||
Financial liabilities | 24,082 | 5,598 |
Accrued expenses and other current liabilities | Less than 1 year | ||
Financial instruments | ||
Financial liabilities | 24,082 | 5,598 |
Borrowing | ||
Financial instruments | ||
Financial liabilities | 136,198 | |
Borrowing | Cost | ||
Financial instruments | ||
Financial liabilities | 81,386 | |
Borrowing | Less than 1 year | ||
Financial instruments | ||
Financial liabilities | 10,154 | |
Borrowing | 2-5 years | ||
Financial instruments | ||
Financial liabilities | 107,514 | |
Borrowing | More than five years | ||
Financial instruments | ||
Financial liabilities | 18,530 | |
Payable in respect of intangible asset purchase | ||
Financial instruments | ||
Financial liabilities | 30,600 | |
Payable in respect of intangible asset purchase | Cost | ||
Financial instruments | ||
Financial liabilities | 24,745 | |
Payable in respect of intangible asset purchase | Less than 1 year | ||
Financial instruments | ||
Financial liabilities | 20,600 | |
Payable in respect of intangible asset purchase | 2-5 years | ||
Financial instruments | ||
Financial liabilities | 10,000 | |
Royalty obligation | ||
Financial instruments | ||
Financial liabilities | 1,786 | 1,393 |
Royalty obligation | Cost | ||
Financial instruments | ||
Financial liabilities | 750 | 500 |
Royalty obligation | Less than 1 year | ||
Financial instruments | ||
Financial liabilities | 127 | |
Royalty obligation | 2-5 years | ||
Financial instruments | ||
Financial liabilities | 747 | 394 |
Royalty obligation | More than five years | ||
Financial instruments | ||
Financial liabilities | $ 912 | $ 999 |
FINANCIAL INSTRUMENTS AND FIN_5
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT - Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Assets | ||
Financial assets at fair value through profits or losses | $ 481 | $ 8,500 |
Level 1 | At fair value | Financial assets at fair value through profit or loss | ||
Assets | ||
Financial assets at fair value through profits or losses | $ 481 | $ 8,500 |
CASH AND CASH EQUIVALENTS (Deta
CASH AND CASH EQUIVALENTS (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
CASH AND CASH EQUIVALENTS. | ||||
Cash in bank | $ 14,264 | $ 6,471 | ||
Short-term bank deposits | 15,031 | 22,552 | ||
Cash and cash equivalents | $ 29,295 | $ 29,023 | $ 29,005 | $ 16,455 |
PREPAID EXPENSES AND OTHER RE_3
PREPAID EXPENSES AND OTHER RECEIVABLES (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
PREPAID EXPENSES AND OTHER RECEIVABLES | ||
Advances to suppliers | $ 2,543 | $ 1,412 |
Discount from service provider | 46 | 63 |
Prepaid expenses | 2,298 | 413 |
Government institutions | 634 | 356 |
Total prepaid expenses and other receivables | $ 5,521 | $ 2,244 |
INVENTORY (Details)
INVENTORY (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
INVENTORY | ||
Raw materials | $ 1,792 | $ 1,590 |
Finished goods | 4,734 | 292 |
Total current inventories | 6,526 | 1,882 |
Inventories recognized as part of cost of revenues | 5,200 | 900 |
Inventories, at net realisable value | $ 400 | $ 100 |
FIXED ASSETS (Details)
FIXED ASSETS (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Fixed assets | ||
Accumulated depreciation | $ 599 | $ 444 |
Fixed assets | 511 | 228 |
Cost | ||
Fixed assets | ||
Fixed assets | 1,110 | 672 |
Office furniture and equipment (including computers) | ||
Fixed assets | ||
Accumulated depreciation | 479 | 324 |
Fixed assets | 274 | 210 |
Office furniture and equipment (including computers) | Cost | ||
Fixed assets | ||
Fixed assets | 753 | 534 |
Leasehold improvements | ||
Fixed assets | ||
Accumulated depreciation | 120 | 120 |
Fixed assets | 237 | 18 |
Leasehold improvements | Cost | ||
Fixed assets | ||
Fixed assets | $ 357 | $ 138 |
LEASES - Amounts Recognized (De
LEASES - Amounts Recognized (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Disclosure of quantitative information about right-of-use assets [line items] | ||
Right-of-use assets | $ 5,192 | $ 3,578 |
Additions to right-of-use assets | 2,900 | 2,800 |
Additions to lease liabilities | 2,900 | 2,800 |
Depreciation charge of right-of-use assets | 1,555 | 894 |
Interest expense (included in financial expenses) | 574 | 390 |
Cash outflow for leases | 2,000 | 1,000 |
Lease liabilities: | ||
Current | 1,710 | 834 |
Non-current | 3,807 | 2,981 |
Lease liabilities | 5,517 | 3,815 |
Properties | ||
Disclosure of quantitative information about right-of-use assets [line items] | ||
Right-of-use assets | 2,593 | 3,199 |
Depreciation charge of right-of-use assets | 607 | 524 |
Vehicles | ||
Disclosure of quantitative information about right-of-use assets [line items] | ||
Right-of-use assets | 2,599 | 379 |
Depreciation charge of right-of-use assets | $ 948 | $ 370 |
INTANGIBLE ASSETS - Changes in
INTANGIBLE ASSETS - Changes in Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Reconciliation of changes in intangible assets | |||
Balance at beginning of year | $ 16,927 | ||
Balance at end of year | 87,879 | $ 16,927 | |
Intangible assets | 87,879 | 16,927 | |
Cost | |||
Reconciliation of changes in intangible assets | |||
Balance at beginning of year | 16,927 | ||
Balance at end of year | 87,879 | 16,927 | |
Intangible assets | 87,879 | 16,927 | |
R&D assets | Cost | |||
Reconciliation of changes in intangible assets | |||
Balance at beginning of year | 5,355 | 5,320 | |
Additions during the year | 402 | 35 | |
Amortization charges | (50) | ||
Balance at end of year | 5,707 | 5,355 | $ 5,320 |
Intangible assets | 5,707 | 5,355 | 5,320 |
Commercialization Assets [Member] | Cost | |||
Reconciliation of changes in intangible assets | |||
Balance at beginning of year | 11,572 | ||
Additions during the year | 77,585 | 11,788 | |
Amortization charges | (6,985) | (216) | |
Balance at end of year | 82,172 | 11,572 | |
Intangible assets | $ 82,172 | $ 11,572 |
INTANGIBLE ASSETS - Narrative (
INTANGIBLE ASSETS - Narrative (Details) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020USD ($) | Mar. 31, 2020 | Dec. 31, 2019 | |
Movantik | |||
Reconciliation of changes in intangible assets | |||
Useful life of assets (in years) | 10 years 6 months | ||
Aemcolo | |||
Reconciliation of changes in intangible assets | |||
Useful life of assets (in years) | 11 years | ||
Recoverable amount of asset or cash-generating unit | $ 9.8 | ||
Impairment loss | $ 0.8 | ||
Change in weighted average cost of capital (“WACC”) used to discount asset’s cash flows | 0.172 | 0.154 | |
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, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT | |||
Defined contribution plans expense | $ 214,000 | $ 184,000 | $ 182,000 |
ACCRUED EXPENSES AND OTHER CU_3
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | ||
Accrued expenses | $ 18,972 | $ 2,996 |
Employees and related liabilities | 4,963 | 1,228 |
Government Institutions | 147 | 107 |
Accrued expenses and other current liabilities | $ 24,082 | $ 4,331 |
ALLOWANCE FOR DEDUCTIONS FROM_3
ALLOWANCE FOR DEDUCTIONS FROM REVENUES (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Disclosure of other provisions [line items] | ||
Balance at beginning of the year | $ 1,267 | $ 958 |
Increases | 59,138 | 2,788 |
Decreases (utilized) | (41,428) | (2,129) |
Adjustments | (634) | (350) |
Balance at end of the year | 18,343 | 1,267 |
Rebates and Patient Discount Programs | ||
Disclosure of other provisions [line items] | ||
Balance at beginning of the year | 1,001 | 573 |
Increases | 56,669 | 2,485 |
Decreases (utilized) | (40,656) | (2,057) |
Adjustments | (634) | |
Balance at end of the year | 16,380 | 1,001 |
Product returns | ||
Disclosure of other provisions [line items] | ||
Balance at beginning of the year | 266 | 385 |
Increases | 2,469 | 303 |
Decreases (utilized) | (772) | (72) |
Adjustments | (350) | |
Balance at end of the year | $ 1,963 | $ 266 |
BORROWING (Details)
BORROWING (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Mar. 12, 2020 | Dec. 31, 2020 | Dec. 31, 2019 |
Disclosure of detailed information about borrowings [line items] | ||||
Restricted cash | $ 16,164 | $ 152 | ||
HCRM | ||||
Disclosure of detailed information about borrowings [line items] | ||||
Maturity term | 6 years | |||
Term, no principal payments required | 3 years | |||
Term, no principal payments if revenue targets unmet | 2 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 | |||
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 |
COMMITMENTS - Agreements to Pur
COMMITMENTS - Agreements to Purchase IP (Details) | Jun. 30, 2014USD ($) | Aug. 11, 2010USD ($)item | Dec. 31, 2014USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Oct. 31, 2019shares | Oct. 17, 2019USD ($)shares | Dec. 31, 2018USD ($)shares | Aug. 31, 2018shares | Mar. 30, 2015USD ($) |
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 | $ 1,000,000 | ||||||||
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% | |||||||||
Salix Pharmaceuticals, Ltd. Agreement | ||||||||||
Commitments | ||||||||||
Upfront initial payment per agreement | $ 7,000,000 | |||||||||
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 | $ 500,000 | $ 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 | |||||||||
ADSs | ||||||||||
Commitments | ||||||||||
Number of shares issued | shares | 2,857,143 | 4,166,667 | ||||||||
Ordinary shares | Cosmo Pharmaceuticals N.V. Strategic Collaboration | Cosmo Pharmaceuticals N.V. | ||||||||||
Commitments | ||||||||||
Number of shares issued | shares | 5,185,715 | |||||||||
Ordinary shares | Cosmo Pharmaceuticals N.V. Strategic Collaboration | Cosmo Technologies Ltd. | ||||||||||
Commitments | ||||||||||
Number of shares issued | shares | 1,714,286 | |||||||||
Ordinary shares | ADSs | Cosmo Pharmaceuticals N.V. | ||||||||||
Commitments | ||||||||||
Number of shares issued | shares | 5,185,715 | |||||||||
Ordinary shares | ADSs | Cosmo Technologies Ltd. | ||||||||||
Commitments | ||||||||||
Number of shares issued | shares | 1,714,286 |
COMMITMENTS - Borrowing (Detail
COMMITMENTS - Borrowing (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Mar. 12, 2020 | Dec. 31, 2020 | Dec. 31, 2019 |
Disclosure of detailed information about borrowings [line items] | ||||
Restricted cash | $ 16,164 | $ 152 | ||
HCRM | ||||
Disclosure of detailed information about borrowings [line items] | ||||
Maturity term | 6 years | |||
Term, no principal payments required | 3 years | |||
Term, no principal payments if revenue targets unmet | 2 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 | |||
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 |
COMMITMENTS - Movantik Acquisit
COMMITMENTS - Movantik Acquisition (Details) - USD ($) $ in Thousands | Apr. 01, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2020 |
Disclosure of detailed information about intangible assets [line items] | |||||
Upfront payment for acquisition of rights | $ 53,368 | $ 35 | $ 35 | ||
Agreement amount payable for acquisition of rights | 26,600 | ||||
Intangible assets | $ 87,879 | $ 16,927 | |||
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 | ||||
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 | ||||
Recoverable amount of intangible asset | $ 9,800 | ||||
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 | 15,500 | ||||
Purchase commitment | $ 25,000 |
COMMITMENTS - DSI Agreement (De
COMMITMENTS - DSI Agreement (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Disclosure of classes of share capital [line items] | ||
Agreement amount payable for acquisition of rights | $ 26,600 | |
Intangible assets | 87,879 | $ 16,927 |
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 | $ 15,500 | |
Movantik | DSI | ADSs | ||
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 |
COMMITMENTS - Payroll Protectio
COMMITMENTS - Payroll Protection Progam (Details) - PPP Loan $ in Millions | 1 Months Ended |
Apr. 30, 2020USD ($) | |
Disclosure of detailed information about borrowings [line items] | |
Loan received | $ 2.3 |
Maturity term | 2 years |
Interest rate (as a percent) | 1.00% |
Period of interest deferral | 6 months |
Period of qualifying expenses that may be forgiven | 56 days |
INCOME TAX (Details)
INCOME TAX (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax [Line Items] | |||
Deductible temporary differences | $ 12 | $ 17 | |
Israel | |||
Income Tax [Line Items] | |||
Corporate tax rate | 23.00% | 23.00% | 23.00% |
Net operating losses | $ 190 | ||
U.S. | |||
Income Tax [Line Items] | |||
Corporate tax rate | 21.00% | 21.00% | 21.00% |
Net operating losses | $ 64 | ||
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 | $ 54 |
SHARE CAPITAL (Details)
SHARE CAPITAL (Details) | 1 Months Ended | 12 Months Ended | ||||||||
Jul. 31, 2020USD ($)shares | Oct. 31, 2019USD ($)shares | Dec. 31, 2018USD ($)shares | Aug. 31, 2018USD ($)shares | Dec. 31, 2020USD ($)$ / shares | Dec. 31, 2019USD ($)shares | Dec. 31, 2020₪ / sharesshares | May 31, 2020$ / sharesshares | Jun. 30, 2019$ / sharesshares | May 31, 2018shares | |
Disclosure of classes of share capital [line items] | ||||||||||
Authorized ordinary shares | 800,000,000 | 600,000,000 | ||||||||
ADSs | ||||||||||
Disclosure of classes of share capital [line items] | ||||||||||
Number of shares issued | 2,857,143 | 4,166,667 | ||||||||
Proceeds from issuance of shares, gross | $ | $ 20,000,000 | $ 25,000,000 | ||||||||
Proceeds from issuance of shares | $ | $ 18,400,000 | $ 23,500,000 | ||||||||
Number of shares issued | 2,857,143 | 4,166,667 | ||||||||
ATM Program | ADSs | ||||||||||
Disclosure of classes of share capital [line items] | ||||||||||
Number of shares issued | 2,837,038 | |||||||||
Share issue related costs | $ | $ 600,000 | |||||||||
Number of shares issued | 2,837,038 | |||||||||
Average share price | $ / shares | $ 8.62 | |||||||||
Share issuance expenses | $ | $ 600,000 | |||||||||
Sales proceeds from issuance of shares | $ | 23,800,000 | |||||||||
ATM Program | ADSs | Maximum | ||||||||||
Disclosure of classes of share capital [line items] | ||||||||||
Proceeds from issuance of shares, gross | $ | 60,000,000 | |||||||||
Ordinary shares | ||||||||||
Disclosure of classes of share capital [line items] | ||||||||||
Par value per share | (per share) | ₪ 0.01 | $ 0.01 | $ 0.01 | |||||||
Authorized ordinary shares | 594,000,000 | 794,000,000 | 794,000,000 | 594,000,000 | ||||||
Issued and paid ordinary shares | 352,696,000 | 383,981,000 | ||||||||
Ordinary shares | ADSs | Cosmo Pharmaceuticals N.V. | ||||||||||
Disclosure of classes of share capital [line items] | ||||||||||
Number of shares issued | 5,185,715 | |||||||||
Proceeds from issuance of shares | $ | $ 36,300,000 | |||||||||
Number of shares issued | 5,185,715 | |||||||||
Ordinary shares | ADSs | Cosmo Technologies Ltd. | ||||||||||
Disclosure of classes of share capital [line items] | ||||||||||
Number of shares issued | 1,714,286 | |||||||||
Number of shares issued | 1,714,286 | |||||||||
Ordinary shares | ADSs | DSI | ||||||||||
Disclosure of classes of share capital [line items] | ||||||||||
Number of shares issued | 283,387 | |||||||||
Proceeds from issuance of shares | $ | $ 2,000,000 | |||||||||
Number of shares issued | 283,387 | |||||||||
Ordinary shares | Stock Options | ||||||||||
Disclosure of classes of share capital [line items] | ||||||||||
Number of shares issued | 8,750 | 8,156 | ||||||||
Proceeds from exercise of options | $ | $ 52,000 | $ 5,000 | ||||||||
Number of shares issued | 8,750 | 8,156 | ||||||||
Preferred shares | ||||||||||
Disclosure of classes of share capital [line items] | ||||||||||
Par value per share | $ / shares | $ 0.01 | $ 0.01 | ||||||||
Authorized ordinary shares | 6,000,000 | 6,000,000 | ||||||||
Authorized preferred shares (reserved) | 6,000,000 | 6,000,000 |
SHARE-BASED PAYMENTS (Details)
SHARE-BASED PAYMENTS (Details) | Dec. 31, 2020USD ($)Optionshares | May 04, 2020USD ($) | Jun. 24, 2019USD ($) | Dec. 31, 2020USD ($)Option | Dec. 31, 2020USD ($)Optioninstallment | Dec. 31, 2020USD ($)Option | Dec. 31, 2020USD ($)Option$ / shares | Dec. 31, 2020USD ($)Option | Dec. 31, 2020USD ($)Option | Dec. 31, 2019USD ($)Option | Dec. 31, 2019USD ($)Option$ / shares | Dec. 31, 2019USD ($)Option | Dec. 31, 2019USD ($)Option |
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||||||||
Number of options granted | 1,651,000 | 1,651,000 | 1,185,000 | 1,185,000 | |||||||||
Exercise price for 1 ADS ($) | $ / shares | $ 6.90 | $ 8.70 | |||||||||||
Fair value of options on date of grant in U.S. $ thousands | $ 5,233,000 | $ 5,233,000 | $ 5,233,000 | $ 5,233,000 | $ 5,233,000 | $ 5,233,000 | $ 5,233,000 | $ 4,671,000 | $ 4,671,000 | $ 4,671,000 | $ 4,671,000 | ||
Each option exercisable into number of ordinary shares, ratio | Option | 3,178,317 | 3,178,317 | 3,178,317 | 3,178,317 | 3,178,317 | 3,178,317 | 3,178,317 | 2,490,292 | 2,490,292 | 2,490,292 | 2,490,292 | ||
February 2019 | |||||||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||||||||
Number of options granted | 158,000 | ||||||||||||
Exercise price for 1 ADS ($) | $ / shares | $ 8.90 | ||||||||||||
Fair value of options on date of grant in U.S. $ thousands | $ 628,000 | $ 628,000 | $ 628,000 | $ 628,000 | |||||||||
May 2019 | |||||||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||||||||
Number of options granted | 564,000 | ||||||||||||
Exercise price for 1 ADS ($) | $ / shares | $ 9.20 | ||||||||||||
Fair value of options on date of grant in U.S. $ thousands | 2,433,000 | $ 2,433,000 | 2,433,000 | $ 2,433,000 | |||||||||
June 2019 | |||||||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||||||||
Number of options granted | 187,500 | 187,500 | |||||||||||
Exercise price for 1 ADS ($) | $ / shares | $ 9.20 | ||||||||||||
Fair value of options on date of grant in U.S. $ thousands | 641,000 | $ 641,000 | 641,000 | $ 641,000 | |||||||||
July 2019 | |||||||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||||||||
Number of options granted | 43,500 | ||||||||||||
Exercise price for 1 ADS ($) | $ / shares | $ 8 | ||||||||||||
Fair value of options on date of grant in U.S. $ thousands | 173,000 | $ 173,000 | 173,000 | $ 173,000 | |||||||||
September 2019 | |||||||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||||||||
Number of options granted | 35,000 | ||||||||||||
Exercise price for 1 ADS ($) | $ / shares | $ 8 | ||||||||||||
Fair value of options on date of grant in U.S. $ thousands | 150,000 | $ 150,000 | 150,000 | $ 150,000 | |||||||||
November 2019 | |||||||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||||||||
Number of options granted | 60,000 | ||||||||||||
Exercise price for 1 ADS ($) | $ / shares | $ 7.60 | ||||||||||||
Fair value of options on date of grant in U.S. $ thousands | 195,000 | $ 195,000 | 195,000 | $ 195,000 | |||||||||
December 2019 | |||||||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||||||||
Number of options granted | 137,000 | ||||||||||||
Exercise price for 1 ADS ($) | $ / shares | $ 6.90 | ||||||||||||
Fair value of options on date of grant in U.S. $ thousands | $ 451,000 | $ 451,000 | $ 451,000 | $ 451,000 | |||||||||
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. $ thousands | $ 243,000 | $ 243,000 | $ 243,000 | $ 243,000 | $ 243,000 | $ 243,000 | $ 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. $ thousands | 119,000 | 119,000 | 119,000 | 119,000 | $ 119,000 | 119,000 | $ 119,000 | ||||||
March 2020 | |||||||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||||||||
Number of options granted | 429,000 | ||||||||||||
Exercise price for 1 ADS ($) | $ / shares | $ 4.87 | ||||||||||||
Fair value of options on date of grant in U.S. $ thousands | 970,000 | 970,000 | 970,000 | 970,000 | $ 970,000 | 970,000 | $ 970,000 | ||||||
May 2020 | |||||||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||||||||
Number of options granted | 219,000 | 218,000 | |||||||||||
Exercise price for 1 ADS ($) | $ / shares | $ 7.50 | ||||||||||||
Fair value of options on date of grant in U.S. $ thousands | 831,000 | 831,000 | 831,000 | 831,000 | $ 831,000 | 831,000 | $ 831,000 | ||||||
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. $ thousands | 2,671,000 | 2,671,000 | 2,671,000 | 2,671,000 | $ 2,671,000 | 2,671,000 | $ 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. $ thousands | 45,000 | 45,000 | 45,000 | 45,000 | $ 45,000 | 45,000 | $ 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. $ thousands | 264,000 | 264,000 | 264,000 | 264,000 | $ 264,000 | 264,000 | $ 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. $ thousands | $ 90,000 | $ 90,000 | $ 90,000 | $ 90,000 | $ 90,000 | $ 90,000 | $ 90,000 | ||||||
Stock Options | |||||||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||||||||
Shares approved for issuance | shares | 59,206,448 | ||||||||||||
Stock Options | 2019 | Minimum | |||||||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||||||||
Price of the Company's ordinary shares | $ / shares | $ 6.1 | ||||||||||||
Expected volatility | 57.48% | ||||||||||||
Risk free interest rate | 1.63% | ||||||||||||
Stock Options | 2019 | Maximum | |||||||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||||||||
Price of the Company's ordinary shares | $ / shares | $ 8.3 | ||||||||||||
Expected volatility | 58.27% | ||||||||||||
Risk free interest rate | 2.67% | ||||||||||||
Stock Options | 2020 | |||||||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||||||||
Option term | 10 years | ||||||||||||
Stock Options | 2020 | 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 | 57.73% | ||||||||||||
Risk free interest rate | 0.64% | ||||||||||||
Stock Options | 2020 | 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 | 63.63% | ||||||||||||
Risk free interest rate | 1.51% | ||||||||||||
Stock Options | 2020 | 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 | 2020 | Vesting, services exceeding one year | Minimum | |||||||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||||||||
Service period | 1 year | ||||||||||||
Stock Options | 2020 | 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 | 2020 | 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 | 2020 | 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 | 997,500 | |||||||||||
Other than directors | February 2019 | |||||||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||||||||
Number of options granted | 158,000 | ||||||||||||
Other than directors | May 2019 | |||||||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||||||||
Number of options granted | 564,000 | ||||||||||||
Other than directors | July 2019 | |||||||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||||||||
Number of options granted | 43,500 | ||||||||||||
Other than directors | September 2019 | |||||||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||||||||
Number of options granted | 35,000 | ||||||||||||
Other than directors | November 2019 | |||||||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||||||||
Number of options granted | 60,000 | ||||||||||||
Other than directors | December 2019 | |||||||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||||||||
Number of options granted | 137,000 | ||||||||||||
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 | ||||||||||||
To directors | |||||||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||||||||
Number of options granted | 219,000 | 187,500 | |||||||||||
To directors | June 2019 | |||||||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||||||||
Number of options granted | 187,500 | ||||||||||||
To directors | March 2020 | |||||||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||||||||
Number of options granted | 144,000 | ||||||||||||
To directors | May 2020 | |||||||||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||||||||||||
Number of options granted | 75,000 |
SHARE-BASED PAYMENTS - Number o
SHARE-BASED PAYMENTS - Number of Options and Weighted Averages of Exercise Prices (Details) | 12 Months Ended | |||||
Dec. 31, 2020Option$ / shares | Dec. 31, 2020Option$ / shares | Dec. 31, 2020OptionUSD ($)$ / shares | Dec. 31, 2019Option$ / shares | Dec. 31, 2019Option$ / shares | Dec. 31, 2019OptionUSD ($)$ / shares | |
SHARE-BASED PAYMENTS | ||||||
Number of options, outstanding at beginning of year | Option | 4,050,898 | 2,936,024 | ||||
Number of options, exercised | Option | (8,156) | (875) | ||||
Number of options, expired and forfeited | Option | (264,939) | (69,250) | ||||
Number of options, granted | 1,651,000 | 1,651,000 | 1,185,000 | 1,185,000 | ||
Number of options, outstanding at end of year | Option | 5,428,803 | 4,050,898 | ||||
Number of options, exercisable at end of year | Option | 3,178,317 | 3,178,317 | 3,178,317 | 2,490,292 | 2,490,292 | 2,490,292 |
Weighted average of exercise price, outstanding at beginning of year | $ 10.30 | $ 10.50 | ||||
Weighted average of exercise price, exercised | 6.38 | 6.10 | ||||
Weighted average of exercise price, expired and forfeited | 9.65 | 10.30 | ||||
Weighted average of exercise price, granted | 6.90 | 8.70 | ||||
Weighted average of exercise price, outstanding at end of year | 9.08 | 10.30 | ||||
Weighted average of exercise price, exercisable at end of year | $ 10.19 | $ 10.19 | $ 10.19 | $ 11.40 | $ 11.40 | $ 11.40 |
SHARE-BASED PAYMENTS - Informat
SHARE-BASED PAYMENTS - Information About Exercise Price and Remaining Useful Life of Outstanding Options (Details) | 12 Months Ended | ||
Dec. 31, 2020Option$ / shares | Dec. 31, 2019Option$ / shares | Dec. 31, 2018Option | |
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items] | |||
Number of options outstanding at end of Year | Option | 5,428,803 | 4,050,898 | 2,936,024 |
Weighted average of remaining useful life | 5 years 10 months 24 days | 5 years 2 months 12 days | |
Minimum | |||
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items] | |||
Exercise price range | $ 5.60 | $ 5.60 | |
Maximum | |||
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items] | |||
Exercise price range | $ 16.10 | $ 16.10 |
SHARE-BASED PAYMENTS - Expenses
SHARE-BASED PAYMENTS - Expenses Recognized in Profit or Loss (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
SHARE-BASED PAYMENTS | |||
Expenses recognized in profit or loss | $ 4,202 | $ 3,027 | $ 2,678 |
Unrecognized compensation expenses | $ 4,500 |
NET REVENUES (Details)
NET REVENUES (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenues | |||
Other Revenues | $ 5,003 | $ 6,291 | $ 8,360 |
Revenue | 64,359 | 6,291 | 8,360 |
Revenue from promotional services | 3,100 | 3,700 | |
Revenue from commercialization of products | $ 3,200 | $ 4,700 | |
Movantik | |||
Revenues | |||
Revenues | $ 59,356 |
RESEARCH AND DEVELOPMENT EXPE_3
RESEARCH AND DEVELOPMENT EXPENSES (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Research And Development Expenses Net [Line Items] | |||
Research and development expenses | $ 16,491 | $ 17,419 | $ 24,862 |
Payroll and related expenses | |||
Research And Development Expenses Net [Line Items] | |||
Research and development expenses, gross | 636 | 623 | 552 |
Professional services and consulting fees | |||
Research And Development Expenses Net [Line Items] | |||
Research and development expenses, gross | 1,752 | 2,345 | 2,297 |
Share-based payments | |||
Research And Development Expenses Net [Line Items] | |||
Research and development expenses, gross | 883 | 671 | 872 |
Clinical and pre-clinical trials | |||
Research And Development Expenses Net [Line Items] | |||
Research and development expenses, gross | 12,569 | 12,840 | 20,373 |
Intellectual property development | |||
Research And Development Expenses Net [Line Items] | |||
Research and development expenses, gross | 298 | 317 | 290 |
Other | |||
Research And Development Expenses Net [Line Items] | |||
Research and development expenses, gross | $ 353 | $ 623 | $ 478 |
SELLING, MARKETING AND BUSINE_3
SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Selling Marketing And Business Development Expenses [Line Items] | |||
Selling, marketing and business development expenses | $ 49,285 | $ 18,333 | $ 12,486 |
Payroll and related expenses | |||
Selling Marketing And Business Development Expenses [Line Items] | |||
Selling, marketing and business development expenses | 20,756 | 9,335 | 7,540 |
Share-based payments | |||
Selling Marketing And Business Development Expenses [Line Items] | |||
Selling, marketing and business development expenses | 1,464 | 941 | 575 |
Professional services | |||
Selling Marketing And Business Development Expenses [Line Items] | |||
Selling, marketing and business development expenses | 18,957 | 3,680 | 1,626 |
Samples | |||
Selling Marketing And Business Development Expenses [Line Items] | |||
Selling, marketing and business development expenses | 438 | 178 | |
Travel, fleet, meals and related expenses | |||
Selling Marketing And Business Development Expenses [Line Items] | |||
Selling, marketing and business development expenses | 5,729 | 2,193 | 1,822 |
Office related expenses | |||
Selling Marketing And Business Development Expenses [Line Items] | |||
Selling, marketing and business development expenses | 957 | 789 | 495 |
Other | |||
Selling Marketing And Business Development Expenses [Line Items] | |||
Selling, marketing and business development expenses | $ 984 | $ 1,217 | $ 428 |
GENERAL AND ADMINISTRATIVE EX_3
GENERAL AND ADMINISTRATIVE EXPENSES (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
General And Administrative Expense [Line Items] | |||
General and administrative expenses | $ 25,375 | $ 11,481 | $ 7,506 |
Payroll and related expenses | |||
General And Administrative Expense [Line Items] | |||
General and administrative expenses | 11,159 | 4,903 | 3,880 |
Share-based payments | |||
General And Administrative Expense [Line Items] | |||
General and administrative expenses | 1,855 | 1,415 | 1,231 |
Professional services | |||
General And Administrative Expense [Line Items] | |||
General and administrative expenses | 9,132 | 3,479 | 1,461 |
Medical affairs | |||
General And Administrative Expense [Line Items] | |||
General and administrative expenses | 1,052 | 299 | |
Office related expenses | |||
General And Administrative Expense [Line Items] | |||
General and administrative expenses | 1,168 | 585 | 547 |
Other | |||
General And Administrative Expense [Line Items] | |||
General and administrative expenses | $ 1,009 | $ 800 | $ 387 |
FINANCIAL (INCOME) EXPENSES, _3
FINANCIAL (INCOME) EXPENSES, net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
FINANCIAL (INCOME) EXPENSES, net | |||
Fair value gain on derivative financial instruments | $ 344 | $ 104 | |
Gains on financial assets at fair value through profit or loss | $ 94 | 474 | 295 |
Gain from changes in exchange rates | 74 | ||
Interest from bank deposits | 176 | 443 | 279 |
Financial income | 270 | 1,335 | 678 |
Interest and finance charges for lease liabilities | 405 | 390 | |
Loss from changes in exchange rates | 9 | 125 | |
Interest expenses related to borrowing and payable in respect of intangible assets purchase | 12,045 | ||
Other | 300 | 48 | 42 |
Financial expenses | 12,759 | 438 | 167 |
Financial (income) /expenses, net | $ 12,489 | $ (897) | $ (511) |
SEGMENT INFORMATION (Details)
SEGMENT INFORMATION (Details) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020USD ($)segment | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | |
Disclosure of operating segments [line items] | |||
Number of segments | segment | 2 | ||
Net revenues | $ 64,359 | $ 6,291 | $ 8,360 |
Cost of revenues | 36,892 | 2,259 | 2,837 |
GROSS PROFIT | 27,467 | 4,032 | 5,523 |
Research and development expenses, net | 16,491 | 17,419 | 24,862 |
Selling, marketing and business development expenses | 49,285 | 18,333 | 12,486 |
General and administrative expenses | 25,375 | 11,481 | 7,506 |
OPERATING LOSS | 63,684 | 43,201 | 39,331 |
Commercial Operations | |||
Disclosure of operating segments [line items] | |||
Net revenues | 64,359 | 6,291 | 8,360 |
Cost of revenues | 36,892 | 2,259 | 2,837 |
GROSS PROFIT | 27,467 | 4,032 | 5,523 |
Selling, marketing and business development expenses | 47,468 | 16,854 | 11,329 |
General and administrative expenses | 17,597 | 5,173 | 2,795 |
OPERATING LOSS | 37,598 | 17,995 | 8,601 |
Research and Development | |||
Disclosure of operating segments [line items] | |||
Research and development expenses, net | 16,491 | 17,419 | 24,862 |
Selling, marketing and business development expenses | 1,817 | 1,479 | 1,157 |
General and administrative expenses | 7,778 | 6,308 | 4,711 |
OPERATING LOSS | $ 26,086 | $ 25,206 | $ 30,730 |
SEGMENT INFORMATION - Major Cus
SEGMENT INFORMATION - Major Customers and Segment Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Disclosure of major customers [line items] | |||
Non-current assets | $ 109,746 | $ 20,885 | |
Intangible assets | 87,879 | 16,927 | |
Restricted cash | 16,164 | 152 | |
Right-of-use assets | 5,192 | $ 3,578 | |
Israel | |||
Disclosure of major customers [line items] | |||
Non-current assets | 7,500 | ||
Intangible assets | 5,700 | ||
Right-of-use assets | 1,400 | ||
U.S. | |||
Disclosure of major customers [line items] | |||
Non-current assets | 102,300 | ||
Intangible assets | 82,200 | ||
Restricted cash | 16,000 | ||
Right-of-use assets | $ 3,800 | ||
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 | 35.00% | ||
Customer B | |||
Disclosure of major customers [line items] | |||
Percentage of revenue | 28.00% | ||
Customer C | |||
Disclosure of major customers [line items] | |||
Percentage of revenue | 35.00% | 10.00% | |
Customer D | |||
Disclosure of major customers [line items] | |||
Percentage of revenue | 45.00% | 42.00% | |
Customer E | |||
Disclosure of major customers [line items] | |||
Percentage of revenue | 18.00% | 46.00% |
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, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Basic | |||
Loss (U.S. dollars in thousands) | $ 76,173 | $ 42,304 | $ 38,820 |
Weighted average number of ordinary shares outstanding during the period (in thousands) | 364,276 | 296,922 | 231,204 |
Basic loss per share (U.S. dollars) | $ 0.21 | $ 0.14 | $ 0.17 |
RELATED PARTIES - Key Managemen
RELATED PARTIES - Key Management Compensation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
RELATED PARTIES | |||
Salaries and other short-term employee benefits | $ 1,526 | $ 876 | $ 734 |
Post-employment benefits | 61 | 43 | 36 |
Share-based payments | 710 | 468 | 510 |
Other long-term benefits | $ 33 | $ 26 | $ 26 |
RELATED PARTIES - Balances with
RELATED PARTIES - Balances with Related Parties (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current liabilities | ||
Credit balance in “accrued expenses and other current liabilities” | $ 484 | $ 175 |
EVENTS SUBSEQUENT TO DECEMBER_2
EVENTS SUBSEQUENT TO DECEMBER 31, 2020 (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | |||||
Feb. 28, 2021 | Jan. 31, 2021 | Dec. 31, 2018 | Aug. 31, 2018 | Mar. 31, 2021 | Mar. 11, 2021 | Dec. 31, 2020 | |
Disclosure of non-adjusting events after reporting period [line items] | |||||||
Agreement amount payable for acquisition of rights | $ 26.6 | ||||||
ADSs | |||||||
Disclosure of non-adjusting events after reporting period [line items] | |||||||
Number of shares issued | 2,857,143 | 4,166,667 | |||||
Proceeds from issuance of shares, gross | $ 20 | $ 25 | |||||
Proceeds from issuance of shares | $ 18.4 | $ 23.5 | |||||
ADSs | Major ordinary share transactions | |||||||
Disclosure of non-adjusting events after reporting period [line items] | |||||||
Number of shares issued | 4,647,433 | 3,188,776 | 428,421 | ||||
Proceeds from issuance of shares, gross | $ 37 | $ 25 | |||||
Proceeds from issuance of shares | $ 34.8 | $ 23.1 | $ 3.5 | ||||
Movantik | AstraZeneca AB | |||||||
Disclosure of non-adjusting events after reporting period [line items] | |||||||
Agreement amount payable for acquisition of rights | $ 15.5 | ||||||
Movantik | AstraZeneca AB | Agreement amendment | |||||||
Disclosure of non-adjusting events after reporting period [line items] | |||||||
Agreement amount payable for acquisition of rights | $ 16 |