CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) - USD ($) $ in Thousands |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
| CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) | |||
| NET REVENUES | $ 8,043 | $ 6,530 | $ 61,800 |
| COST OF REVENUES | 3,192 | 3,459 | 33,337 |
| GROSS PROFIT | 4,851 | 3,071 | 28,463 |
| RESEARCH AND DEVELOPMENT EXPENSES | 1,588 | 3,528 | 7,279 |
| SELLING AND MARKETING EXPENSES | 5,950 | 14,756 | 35,442 |
| GENERAL AND ADMINISTRATIVE EXPENSES | 9,567 | 16,219 | 28,586 |
| OTHER INCOME (EXPENSES) | (2,359) | 44,064 | |
| OPERATING INCOME (LOSS) | (14,613) | 12,632 | (42,844) |
| FINANCIAL INCOME | 8,401 | 20,889 | 13,562 |
| FINANCIAL EXPENSES | 2,056 | 9,605 | 42,387 |
| Financial income (expenses), net | 6,345 | 11,284 | (28,825) |
| INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS) FOR THE YEAR | $ (8,268) | $ 23,916 | $ (71,669) |
| EARNINGS (LOSS) PER ORDINARY SHARE, basic (U.S. dollars) | $ 0 | $ 0.01 | $ (0.12) |
| EARNINGS (LOSS) PER ORDINARY SHARE, diluted (U.S. dollars) | $ 0 | $ 0.01 | $ (0.12) |
CONSOLIDATED STATEMENTS OF CASH FLOWS (Parenthetical) - USD ($) $ in Thousands |
12 Months Ended | |
|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
|
| CONSOLIDATED STATEMENTS OF CASH FLOWS | ||
| Decrease in right o fuse assets | $ 166 | $ 4,697 |
GENERAL |
12 Months Ended | |||
|---|---|---|---|---|
Dec. 31, 2024 | ||||
| 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, were listed on the Nasdaq Global Market (“Nasdaq”) from July 20, 2018, and have been again listed on the Nasdaq Capital Market since November 15, 2023. On March 23, 2023, the Company changed the ADS ratio from 1 ADS representing 10 ordinary shares to 1 ADS representing 400 ordinary shares. On August 20, 2024, the Company changed the ADS to ordinary share ratio from 1 ADS representing 400 ordinary shares to 1 ADS representing 10,000 ordinary shares. All data denominated in ADS were adjusted for these ratio changes. The Company’s registered address is 21 Ha’arba’a St, Tel-Aviv, Israel.
3) Through December 31, 2024, the Company has an accumulated deficit and negative working capital, and its activities have been funded primarily through public and private offerings of the Company’s securities and senior secured borrowing (now fully extinguished, see note 15(6)). There is no assurance that the Company’s business will generate sustainable positive cash flows to fund its business. 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 other non-dilutive financing. Furthermore, the Company actively pursuing and in discussions with multiple parties regarding strategic business transaction although there is no guarantee the discussions will result in any strategic business transactions. The Company’s current cash resources are not sufficient to complete the research and development of any or 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. Management believes that there is presently insufficient funding available to allow the Company to fund its activities for a period exceeding one year from the date of this filing. These conditions and events indicate that a material uncertainty exists that may cast significant doubt (or raise substantial doubt as contemplated by PCAOB standards) about the Company’s ability to continue as a going concern. The accompanying financial statements have been prepared assuming that the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty. 4) In October 2023, Israel was attacked by a terrorist organization and entered a state of war. As of the date of these consolidated financial statements, sustained conflict in the region is ongoing. During the year ended December 31, 2024 and 2023, the impact of this war on the Company results and financial condition was immaterial, but such impact may increase. b. Approval of the financial statements: The date of the approval of these financial statements by the Board of Directors (the "BoD") is April 10, 2025. |
SUMMARY OF MATERIAL ACCOUNTING POLICIES |
12 Months Ended | |||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | ||||||||||||||||||||||||||||||||
| SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||||||||||||||||||||||||||||||||
| SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 2 - SUMMARY OF MATERIAL ACCOUNTING POLICIES: a. Basis for presentation of the financial statements The consolidated financial statements of the Company have been prepared in accordance with IFRS Accounting Standards as issued by the International Accounting Standards Board. (“IASB”). The material accounting policies described below have been applied consistently in relation to all the periods presented, except for the adoption of IAS 1 amendments effective January 1, 2024, as described in note 2(m)(1). 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 material to the financial statements, are disclosed in note 3. Actual results could differ significantly from those estimates and assumptions. b. Translation of foreign currency transactions and balances 1) Functional and presentation currency Items included in the consolidated financial statements are measured using the currency of the primary economic environment in which the Company and its subsidiary operate (the “Functional Currency”). The consolidated financial statements are presented in U.S. dollars (“$”), which is the Company’s functional and presentation currency. 2) Transactions and balances Foreign currency transactions in currencies different from the Functional Currency (hereafter foreign currency, mostly New Israeli Shekel (“NIS”) and Euro are translated into the Functional Currency using the exchange rates at the dates of the transactions. Foreign exchange differences resulting from the settlement of such transactions and from the translation of period-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recorded in the Consolidated Statements of Comprehensive Income (Loss) under financial income or financial expenses.
c. Trade receivables Trade receivables are recognized initially at the amount of consideration that is unconditional. They are subsequently measured at amortized cost, less allowance for expected credit losses. The Company measures the loss allowance for expected credit losses on trade receivables based on lifetime expected credit losses. d. Inventory The Company’s inventory is stated at the lower of cost or net realizable value. Cost of inventory is determined using the first-in, first-out method. Net realizable value is the estimated selling price in the ordinary course of business, less the estimated costs of completion and the estimated costs necessary to make the sale. 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. e. 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:
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. f. 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") which were fully derecognized in 2023 as part of the sale of the rights to Movantik® asset (See also note 15(6)). R&D assets that are available for use are stated at cost and amortized on a straight-line basis over their useful life from the time they are available for use. R&D assets that are not available for use are not amortized and are tested for impairment at least annually. Amounts due for future payments 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. 2) Research and development Research expenses are recognized as an expense as incurred. Research and development costs for the performance of pre-clinical trials, clinical trials, and manufacturing by subcontractors are recognized as expenses when incurred.
g. Financial liabilities Non-derivative financial liabilities are initially recognized at their fair value minus transaction costs and are subsequently measured at amortized cost. In case there is a difference between the fair value at initial recognition and the transaction price (“day 1 loss”), the financial liabilities are adjusted to reflect the day 1 loss and changes are recorded to profit or loss while unrecognized day 1 loss is amortized over the contractual life of the instrument. Any amounts not recognized in profit or loss before the date of exercise or maturity will be recognized in profit or loss on that date. Warrants exercisable to the Company’s ordinary shares are classified as an equity instrument only if the warrants are settled by the Company exchanging a fixed amount of cash for a fixed number of its own equity instruments (the ‘fixed for fixed’ criteria). Otherwise, the warrants are classified as a derivative financial liability measured at fair value through profit or loss. Transaction costs relating to the issuance of derivative financial liabilities measured at fair value through profit or loss are expensed to profit or loss. Financial liabilities are included in current liabilities, except for those with maturities greater than 12 months after the Statements of Financial Position date (for which they are classified as noncurrent liabilities). Financial liabilities are derecognized when, and only when, they are extinguished. The difference between the carrying amount of the financial liability extinguished and the consideration paid, including any non-cash assets transferred, is recognized in profit or loss. As for the accounting for the extinguishment of the financial liability to HCR, as well as the Global Termination Agreement which terminated all remaining credit ties related to this transaction, see note 15(6). h. Share-based payments. The Company operates several equity-settled, share-based compensation plans to employees 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. For employees, the total amount recognized as an expense over the vesting period of the options is determined by reference to the fair value of the options at the grant date. For service providers, the Company measures the awards based on the fair value of the asset or service received. The amounts are recorded against the accumulated deficit within equity. Vesting conditions (other than market conditions) are included in the assumptions about the number of options that are expected to vest. 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 additional paid-in capital. i. Revenue from contracts with customers The Company generated revenue in the years presented in these financial statements mainly from product sales, including in-licensed 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 Company estimates variable consideration and includes it in the transaction price 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. See also notes 3 and 13. Product returns - The Company offers customers a right of return of expired products. 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.
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. 3) Revenues from licensing Licenses of intellectual property (“IP”) rights are distinct from other promises in a contract with a customer (such as manufacturing and supply services) if the customer can benefit from the IP either on its own or together with other resources that are readily available to the customer and if the Company’s promise to license the IP is separately identifiable from other promises in the contract. If the promise to grant the license is distinct, the Company determines whether the nature of the promise in granting the license is to provide the customer with either a right to access the Company’s IP as it exists throughout the license period or a right to use the Company’s IP as it exists at the point in time at which the license is granted. Accordingly, revenue from a license providing a right of use to the Company’s IP is recognized at the point in time when control of the distinct license is transferred to the customer. Sales -based royalties that are allocated to license of IP are recognized only when (or as) the later of the following occurs: (a) the subsequent sale occurs; and (b) the performance obligation to which some or all the sales-based royalty has been allocated has been satisfied (or partially satisfied). The Company applies a practical expedient in the standard and does not adjust the transaction price for the effects of significant financing components if, at contract inception, the Company expects the period between customer payment and the transfer of goods or services to be one year or less. Revenue from achieving additional milestones is recognized only when it is highly probable that a significant reversal of cumulative revenues will not occur, usually upon achievement of the specific milestone, in accordance with the relevant agreement.
j. Earnings (Loss) per share The computation of basic earnings (loss) per share is based on the Company’s earnings (loss) divided by the weighted average number of ordinary shares and pre-funded warrants outstanding during the period. In calculating the diluted earnings (loss) per share, using the treasury stock method, the Company adds the weighted average of the number of shares to be issued to the average number of shares outstanding including pre-funded warrants used to calculate the basic earnings (loss) per share, assuming all shares that have a potentially dilutive effect have been exercised into shares. k. Deferred taxes 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.
l. Leases 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 fixed lease 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, as the interest rate implicit in the lease is not readily determined. 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, the Company has elected not to separate lease and non-lease components and instead accounts for these as a single lease component. m. New international financial reporting standards, amendments to standards and new interpretations:
The narrow-scope amendments to IAS 1, “Presentation of Financial Statements,” clarify that liabilities are classified as either current or noncurrent, depending on the rights that exist at the end of the reporting period. Classification is unaffected by the entity’s expectations or events after the reporting date. The amendments also clarify what IAS 1 means when it refers to the settlement’ of a liability. The amendments may affect the classification of liabilities, particularly for entities that previously considered management’s intentions to determine classification and for some liabilities that can be converted into equity. The Company adopted these amendments effective January 1, 2024. The impact on the Company’s financial statements of these amendments was the reclassification of the Company’s derivative financial instruments from non-current to current as of its effective date, as the Company does not have the right to defer settlement of liability for at least twelve months after the reporting period. The Company has retrospectively applied the amendments in these interim financial statements and, accordingly, has retrospectively adjusted the comparative balance sheet for December 31, 2023, to reclassify its warrant liabilities ($741 as of December 31, 2023) from non-current to current. Adoption of the amendments had no other impact on the Company’s financial statements.
This standard replaces the international accounting standard IAS 1, “Presentation of Financial Statements.” As part of the new disclosure requirements, companies will be required to present new defined subtotals in the statements of income, as follows: (1) operating profit and (2) profit before financing and tax. In addition, income statement items will be classified into three defined categories: operating, investment and financing. The standard also includes a requirement to provide a separate disclosure in the financial statements regarding the use of management-defined performance measures (“non-GAAP measures”), and specific instructions were added for the grouping and splitting of items in the financial statements and in the notes to the financial statements. IFRS 18 is effective for annual reporting periods beginning on or after January 1, 2027, with an option for early adoption. |
CRITICAL ACCOUNTING ESTIMATES AND JUDGMENTS |
12 Months Ended |
|---|---|
Dec. 31, 2024 | |
| 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 research and development assets. 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. These rebates and discounts, provided to wholesalers and patients, are accounted for as variable consideration, and recognized as a reduction in revenue, for which unsettled amounts are accrued. Rebate allowances are calculated based on historical and estimated utilization at revenue recognition. The main estimates used in recognizing and measuring these allowances relate to the amount of products sold to customers not yet prescribed to patients (units “in the channel”) and the projected duration of selling these units. The Company periodically evaluates its 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 18.1%. 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; amount and timing of projected future cash flows and the Company’s main interest rate risk during the periods. In the years presented in these financial statements, there were no impairments recorded for intangible R&D assets.
|
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| FINANCIAL INSTRUMENTS | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT | NOTE 4 - FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT:
1) Financial risk factors The Company’s faces various financial risks: market risks (including foreign exchange and interest risks), 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 highly rated bank deposits with terms of up to one-year term with exit points. (a) Market risks The Company may face foreign exchange risk due to payments and investments in currencies other than the U.S. dollar, its functional currency. The Company manages the foreign exchange risk by aligning its liquidity currencies with the currencies of expected expenses, based on projected cash flows. A 5% appreciation of the U.S. dollar against the NIS, assuming all other variables remained constant, would have resulted in a negligible change in expenses across all the reported years, indicating immaterial foreign exchange risks. (b) Credit risk Credit risk arises mainly from cash and cash equivalents, bank deposits, restricted cash, 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 from trade receivables involves the potential non-payment by customers. The Company manages this 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 due to revenue concentration among major customers. The Company primarily sells to three major U.S. wholesalers with virtually no historical losses. Considering this and forward-looking customer analyses, no loss allowance for trade receivables was recorded as of December 31, 2024, and December 31, 2023. See also note 24(b). (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 and deposits). This is generally carried out based on the expected cash flow in accordance with practices and limits set by the management of the Company. As of December 31, 2024, the Company has generated revenues from commercialization activities. However, as further described in note 1, no sufficient revenue was generated to compensate for operating expenses. leading to liquidity risks and raising significant doubt about its ability to continue as a going concern. 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.
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. 3) Fair value estimation The carrying amount of cash equivalents, restricted cash, bank deposits, receivables, account payables and accrued expenses approximate their fair value due to their short-term characteristics. The fair value of the Royalty obligation balance is not materially different from its carrying amount. The following table presents the change in derivative liabilities measured at level 3 for the year ended December 31, 2024, and December 31, 2023:
As of December 31, 2024, the unrecognized day 1 loss is $0.8 million. See also notes 17(b) - 17 (f) and 17(i)-17(j). Financial Instruments:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
CASH AND CASH EQUIVALENTS |
12 Months Ended | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | ||||||||||||||||||||||||||||||||||||
| CASH AND CASH EQUIVALENTS. | ||||||||||||||||||||||||||||||||||||
| CASH AND CASH EQUIVALENTS | NOTE 5 - CASH AND CASH EQUIVALENTS:
The carrying amounts of the cash and cash equivalents approximate their fair values. |
|||||||||||||||||||||||||||||||||||
PREPAID EXPENSES AND OTHER RECEIVABLES |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||
| PREPAID EXPENSES AND OTHER RECEIVABLES | |||||||||||||||||||||||||||||||||||||||||
| PREPAID EXPENSES AND OTHER RECEIVABLES | NOTE 6 - PREPAID EXPENSES AND OTHER RECEIVABLES:
The fair value of other receivables which constitute financial assets approximate their carrying amount. |
||||||||||||||||||||||||||||||||||||||||
INVENTORY |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||
| INVENTORY | |||||||||||||||||||||||||||||||||||||||||
| INVENTORY | NOTE 7 - INVENTORY:
During the years ended December 31, 2024, 2023, and 2022, the Company recognized amounts of $3.4 million, $4.4 million, and $9.7 million respectively, in inventory cost as part of cost of revenues. The amounts recognized include write-downs of inventories to net realizable value amounted to $0.2 million in 2024, $1.3 million in 2023, and $2.4 million in 2022. These were recognized as an expense, included in cost of revenues in the Consolidated Statements of Comprehensive Income (Loss). |
||||||||||||||||||||||||||||||||||||||||
FIXED ASSETS |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| FIXED ASSETS | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| FIXED ASSETS | NOTE 8 - FIXED ASSETS: The composition of assets and accumulated depreciation are grouped by major classifications:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
LEASES |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| LEASES | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| LEASES | NOTE 9 - LEASES: Amounts recognized in the consolidated statements of financial position:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
INTANGIBLE ASSETS |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| INTANGIBLE ASSETS | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| INTANGIBLE ASSETS | NOTE 10 - INTANGIBLE ASSETS: a. The Company’s intangible assets represent in-licenses of R&D assets. The changes in those assets are as follows:
The Company estimated the useful life of the assets related to Talicia® at approximately 15 years from marketing approval date November 2019. The amortization expenses are recognized under Cost of Revenues in the Consolidated Statements of Comprehensive Income (Loss). See also note 15 (6) regarding the transfer of the Company’s rights in Movantik® to HCRM in exchange for all the Company’s debt obligations under the Credit Agreement with HCRM. In July 2024, the Company terminated its license agreement with Cosmo Technologies Ltd. (“Cosmo”) for Aemcolo® (see note 15(9)), effective October 8, 2024. Following the termination, the Company derecognized the remaining carrying amounts related to the Aemcolo® intangible asset, including its cost and accumulated amortization and impairment. As the asset had been fully written off as of December 31, 2022, the derecognition had no effect on the Consolidated Statements of Financial Position or Consolidated Statements of Comprehensive Income (Loss). |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT |
12 Months Ended |
|---|---|
Dec. 31, 2024 | |
| LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT | |
| LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT | NOTE 11 - LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT: 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 2024, 2023, and 2022 were $156,000, $206,000, and $261,000, respectively. |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||
| ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | ||||||||||||||||||||||||||||||||||||||||||||||
| ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | NOTE 12- ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES:
|
|||||||||||||||||||||||||||||||||||||||||||||
ALLOWANCE FOR DEDUCTIONS FROM REVENUES |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ALLOWANCE FOR DEDUCTIONS FROM REVENUES | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ALLOWANCE FOR DEDUCTIONS FROM REVENUES | NOTE 13 - ALLOWANCE FOR DEDUCTIONS FROM REVENUES: The following table shows the movement of the allowance for deductions from revenue:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
BORROWING |
12 Months Ended |
|---|---|
Dec. 31, 2024 | |
| BORROWING. | |
| BORROWING | NOTE 14 – BORROWING: Credit agreement with HCRM On February 23, 2020 (“Closing Date”), RedHill Inc. entered into a credit agreement and certain security documents (the “Credit Agreement”) with HCRM.
The Credit Agreement contained certain customary affirmative and negative covenants, including 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. In 2022, the Company did not maintain certain covenants in the Credit Agreement. Subsequently, on February 2, 2023, the Company and RedHill Inc. reached an agreement with HCRM resulting in the extinguishment of all of RedHill Inc. debt obligations (including all principal, interest, revenue interest, prepayment premiums and exit fees) under the Credit Agreement in exchange for the transfer of its rights in Movantik® to Movantik Acquisition Co., an affiliate of HCRM. On July 15, 2024, the Company and RedHill Inc signed a Global Termination Agreement with Movantik Acquisition Co., Valinor Pharma, LLC, and HCR Redhill SPV, LLC, affiliates of HCRM. This agreement terminates the Credit Agreement from February 23, 2020, which was amended on February 2, 2023. See also note 15(6). As described above, the Credit Agreement contained 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 Cash Flows for the relevant periods. Instead, the movements in this restricted cash are presented as financing activities in the Statements of Cash Flows. See also note 15(6).
|
COMMITMENTS |
12 Months Ended | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | ||||||||||
| COMMITMENTS | ||||||||||
| COMMITMENTS | NOTE 15 - COMMITMENTS: Agreements to purchase intellectual property and commercial products: 1) On August 11, 2010, the Company acquired intellectual property for three gastrointestinal therapeutic candidates through an asset purchase agreement with a publicly-traded Australian company. Pursuant to the asset purchase agreement, as amended, the Company paid the Australian company an initial amount of $500,000 and undertook to pay future payments in the range of 7% - 20% from the Company’s revenues that may be generated from the sale and sublicense of the therapeutic candidates, less certain deductible amounts, as detailed in the agreement. Such potential payments are due until termination or expiration of the last of the patents transferred to the Company pursuant to the agreement (each on a product-by-product basis). Through December 31, 2024, the Company has paid the Australian company in total $1.5 million. 2) On June 30, 2014, the Company entered into an agreement with a German company that granted the Company the exclusive worldwide (excluding China, Hong Kong, Taiwan, and Macao) development and commercialization rights to all indications to a therapeutic candidate. Under the terms of the agreement, the Company paid the German company an upfront payment of $1 million and agreed to pay the German company potential tiered royalties, less certain deductible amounts, as detailed in the agreement, ranging from mid-teens and up to 30%. Such potential royalties are due until the later of (i) the expiration of the last to expire licensed patent that covers the product in the relevant country and (ii) the expiration of regulatory exclusivity in the relevant country. Through December 31, 2024, the Company has paid the German company only the initial amount mentioned above. 3) On March 30, 2015, the Company entered into an agreement with a U.S.-based private company that granted the Company the exclusive worldwide development and commercialization rights for all indications to a therapeutic candidate, and additional intellectual property rights, targeting multiple oncology, inflammatory and GI indications. Under the terms of the agreement, the Company undertook to pay the U.S. company an initial amount of $1.5 million and an additional amount of $2 million to be paid on a specific date. In addition, the Company undertook to pay up to $2 million in potential development milestone payments, and potential tiered royalties on revenues, less certain deductible amounts starting in the low double-digits, as detailed in the agreement. Such potential royalties are due until the later of (i) the expiration of the last to expire licensed patent that covers the product in the relevant country; and (ii) the expiration of regulatory exclusivity in the relevant country. Through December 31, 2024, the Company paid the U.S. company a total of $3 million. Following an amendment to the agreement from February 2018, during December 2018, the Company elected to convert the remaining $0.5 million into increased future potential royalty payments. The liability is adjusted based on the Company's expectations for future royalty payments. As of December 31, 2024, and December 31, 2023, the Company recognized $0.50 million and $0.54 million, respectively, as a non-current liability for the potential royalty payments. 4) Movantik® acquisition: Effective April 1, 2020 (the (“Effective Date”), RedHill Inc. entered into an exclusive license agreement with AstraZeneca, granting RedHill Inc. exclusive, worldwide (excluding Europe, Canada) commercialization and development rights to Movantik® (naloxegol). The total acquisition consideration, including upfront payment, discounted present value of the deferred payment amounted to approximately $65 million amortized over 12.5 years from the effective date. See also note 15 (6) regarding the transfer of the Company’s rights in Movantik® to HCRM in exchange for all the Company’s debt obligations under the Credit Agreement with HCRM. 5) As part of the Movantik® acquisition, RedHill Inc. assumed an existing co-commercialization agreement with DSI. Effective July 1, 2020, this agreement was replaced with a new agreement, under which RedHill Inc. committed to payments totaling $15.1 million, of which $10.1 million paid during 2022, and the remaining of $5 million was assumed by HCRM under the agreement described in note 15(6)(a). 6) Movantik Transactions:
Accounting treatment: Prior to the sale of Movantik®, the Company presented the rights to Movantik® as an intangible asset in its consolidated statement of financial position (classified under the non-current assets). In addition, due to the condition described in note 14(a), at the sale date, the carrying amount of the borrowing from HCRM reflected all amounts owing or payable under the Credit Agreement as being immediately due (classified under the current liabilities). The gains from transferring Movantik® rights and extinguishment of debt obligations include: (1) the gain from the sale of Movantik®, reflecting the difference between the carrying value and fair value of the assets transferred, presented as other income in the amount of $35.5 million and (2) the gain from the debt extinguishment, reflecting the difference between the carrying amount (the amortized cost) of the financial liability to HCRM and the fair value of the assets transferred, presented as financial income in the amount of $20.6 million. To determine the fair value of the rights to Movantik®, the Company based its estimate on the terms outlined in a non-binding term sheet with a third party which ultimately did not materialize, which included a cash payment of $95 million for the rights to Movantik®. The fair value of nonmonetary assets relating to Movantik® transferred to settle debt obligations was used to measure debt extinguishment gain. The service fees relating to the transition services are presented in the Company’s consolidated statement of comprehensive income (loss) as other income.
The Global Termination Agreement terminated all existing credit ties, removing the aforementioned lien and restoring control over the restricted escrow funds and settlement of trade balances resulting from the transition services. In connection with the agreement, the Company received approximately $9.9 million in cash for the settlement of liabilities related to Movantik®, that were allocatable to HCRM and its affiliates under their agreements with the Company. As the cash received was less than the total net amount of these liabilities (approximately $12.2 million), the Company recognized a loss of approximately $2.3 million resulting from the termination agreement, presented under other expenses in the Consolidated Statements of Comprehensive Income (Loss). In addition, the Company gained full control over $0.7 million previously held in the restricted account.
A related supply agreement designates the Company (via a third party CMO) as exclusive manufacturer and supplier of Talicia® to Gaelan during the term of the agreement. The Company accounted for the license and manufacturing and supply services as distinct performance obligations, mainly due to the manufacturing not being specialized or unique and can be manufactured by others (i.e. – the good or service is capable of being distinct), as well as due to that the license agreement and the manufacturing and supply services do not significantly affect each other (i.e. – the promise is distinct within the context of the contract). During 2022, the Company provided Gaelan substantially all the documentation which represents the right to use the licensed IP, as well as the paperwork relating to the IP itself and its regulatory documents. Accordingly, and since the manufacturing services are priced at their standalone selling price, the Company recognized the $2 million upfront consideration as revenues in the Consolidated Statements of Comprehensive Income (Loss) for the year ended 2022. In August 2024, Gaelan made its first commercial sale in the UAE, triggering a $0.5 million milestone payment due in August 2025. The Company recognized this milestone as revenue in the Consolidated Statements of Comprehensive Income (Loss) for the year ended 2024, along with royalty revenues from sales made during the year (see also Note 19). 8) In March 2022, the Company entered into an exclusive license agreement with Kukbo Co. Ltd ("Kukbo") for oral opaganib for the treatment of COVID-19 in South Korea,. Under the terms of the license agreement, the Company is entitled to an upfront payment of $1.5 million as well as milestone payments and royalties on net sales. Kukbo is entitled under the agreement to the exclusive rights to opaganib in South Korea for COVID-19. Following Kukbo’s default in paying the Company $5 million under a subscription agreement, dated October 25, 2021, in exchange for ADSs, and of the $1.5 million due under the license agreement as described above, the Company filed a lawsuit in NYC against Kukbo in September 2022. Kukbo subsequently filed claims against RedHill.
In December 2024, the court granted summary judgment in the Company’s favor, awarding approximately $6.5 million in principal, plus accrued interest at a rate of 9% per annum- amounting to approximately $1.8 million as of December 31, 2024. The court also ruled that the Company is entitled to recover its attorneys’ fees, which based on RedHill’s records totaled approximately $1.8 million as of December 31, 2024. Kukbo’s counterclaims were dismissed in full. Kukbo filed a notice of appeal and retains the right to seek an appeal. As of December 31, 2024, the Company had not recognized any revenue under the license agreement as the criteria for revenue recognition were not yet met. The Company is party to a contingency fee agreement with its legal firm, Haynes and Boone, LLP, as amended on December 29, 2024. Under the agreement, the firm is entitled to a double-digit percentage of the gross amount recovered if the case results in a final favorable outcome, not subject to further appeal. If no collection is made within six months of such an outcome, the Company must pay the firm its standard hourly fees incurred since entering into the agreement (approximately $1.1 million as of December 31, 2024). If a recovery is later collected, the Company must pay the balance up to the full contingency-based amount. As the case remains ongoing and has not yet reached a final favorable outcome, the legal fees incurred since entering into the agreement have not been recognized as expenses, as no payment is due unless the Company prevails. 9) In July 2024, the Company terminated its license agreement with Cosmo for Aemcolo®, a treatment for traveler’s diarrhea. The agreement, initially dated October 17, 2019, was officially terminated on October 8, 2024. Upon termination, the Company ceased all commercialization of Aemcolo® and all rights under the agreement reverted to Cosmo.
|
INCOME TAX |
12 Months Ended |
|---|---|
Dec. 31, 2024 | |
| INCOME TAX | |
| INCOME TAX | NOTE 16 - INCOME TAX: a. Taxation of the Company in Israel: 1) Measurement of results for tax purposes The Company elected to compute its taxable income in accordance with Income Tax Regulations (Rules for Accounting for Foreign Investors Companies and Certain Partnerships and Setting their Taxable Income), 1986. Accordingly, the Company’s taxable income or loss is calculated in U.S. dollars. The results of the Company are measured for tax purposes in accordance with Accounting Principles Generally Accepted in Israel (Israeli GAAP). These financial statements are prepared in accordance with IFRS. The differences between IFRS and Israeli GAAP, both on an annual and a cumulative basis cause differences between taxable results and the results are reflected in these financial statements. 2) Tax rates The net income of the Company is subject to the Israeli corporate tax rate. Israeli corporate tax rates is 23%. b. U.S. subsidiary: The Company’s subsidiary is incorporated in the U.S. and is taxed under U.S. tax laws. The applicable corporate tax rate is 21%. 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, 2024, the Company had net operating loss (“NOLs”) carried forward of approximately $350 million. Under Israeli tax laws, carryforward tax losses have no expiration date. As of December 31, 2024, the U.S. subsidiary had a net operating loss carryforward of approximately $45 million, with no expiriation date, 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. 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, 2024, and 2023, were $3 million and $6 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 2018 are therefore considered final. |
SHARE CAPITAL |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| SHARE CAPITAL | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| SHARE CAPITAL | NOTE 17 - SHARE CAPITAL: a. Composition: Company share capital is composed of shares of NIS 0.01 par value, as follows:
The warrants were classified as a financial liability due to a net settlement provision. These derivatives were recognized and subsequently measured at fair value through profit or loss. Upon initial recognition the fair value of the warrants was adjusted to reflect the unrecognized day 1 loss. This unrecognized day 1 loss is amortized over the warrants’ contractual life. Issuance expenses amounted to $0.9 million allocated to the warrants were recorded directly in the Consolidated Statements of Comprehensive Income (Loss). See also note 4.
The warrants were classified as a financial liability due to a net settlement provision. These derivatives were recognized and subsequently measured at fair value through profit or loss. The consideration, net of issue expenses, was allocated to the various issued instruments. Out of the gross consideration, $0.9 million was allocated to the warrants. The remainder of approximately $0.35 million was allocated to equity. Issuance expenses allocated to the liability instruments were recorded directly in the Consolidated Statements of Comprehensive Income (Loss), while those allocated to equity were recorded against additional paid in capital. See also note 4.
The warrants that were issued to the investors may be exercised either for cash or on a cashless basis and were classified as financial liability due to a net settlement provision. Loss from modification of warrants terms as part of the new registered offering with an existing shareholder, in an amount of $0.9 million, was included as a financial expense. See also note 17(c) regarding amendment to the above warrants. The Company has issued to the placement agent warrants to purchase up to 3,600 ADSs with an exercise price of $125 per ADS, exercisable for 5 years. These warrants were classified to the Equity.
The warrants that were issued to the investors may be exercised either for cash or on a cashless basis and were classified as financial liability due to a net settlement provision. As part of the offering, the Company has issued to the placement agent warrants (i) to purchase up to 3,125 ADSs with an exercise price of $42.19 per ADS, exercisable for 5 years (ii) to purchase up to 3,600 ADSs with an exercise price of $42.19 per ADS, exercisable for 4.7 years. These warrants were classified to the Equity.
As part of the offering, the Company has issued to the placement agent warrants to purchase up to 10,325 ADSs with an exercise price of $14.69 per ADS, exercisable for 5 years. These warrants were classified to the Equity.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
SHARE-BASED PAYMENTS |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| SHARE-BASED PAYMENTS | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| SHARE-BASED PAYMENTS | NOTE 18 - 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, 2024, the Award Plan allows the Company to allocate up to 2,717,305,440 options to purchase ordinary shares and RSUs (equivalent to 271,730 ADSs) 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.
During 2024, approximately 2,584 options and RSUs were forfeited, resulting in $0.3 million in reversed expenses.
During 2023, approximately 2,720 options and RSUs were forfeited, resulting in $1.6 million in reversed expenses. c. Changes in the number of options in ADSs and weighted averages of exercise prices are as follows:
d. Changes in the number of RSUs in ADSs during the period are as follows:
f. Expenses recognized in profit or loss for the options and RSUs are as follows:
The remaining compensation expenses as of December 31, 2024, are $0.2 million and will be expensed in full by December 2026. |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
NET REVENUES |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| NET REVENUES | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| NET REVENUES | NOTE 19 - NET REVENUES:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RESEARCH AND DEVELOPMENT EXPENSES |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| RESEARCH AND DEVELOPMENT EXPENSES. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| RESEARCH AND DEVELOPMENT EXPENSES | NOTE 20 - RESEARCH AND DEVELOPMENT EXPENSES:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
SELLING AND MARKETING EXPENSES |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| SELLING AND MARKETING EXPENSES | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| SELLING AND MARKETING EXPENSES | NOTE 21 - SELLING AND MARKETING EXPENSES:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
GENERAL AND ADMINISTRATIVE EXPENSES |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| GENERAL AND ADMINISTRATIVE EXPENSES | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| GENERAL AND ADMINISTRATIVE EXPENSES | NOTE 22 - GENERAL AND ADMINISTRATIVE EXPENSES:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
FINANCIAL INCOME (EXPENSES), net |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| FINANCIAL INCOME (EXPENSES), net | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| FINANCIAL INCOME (EXPENSES), net | NOTE 23 - FINANCIAL INCOME (EXPENSES), net:
( |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
SEGMENT INFORMATION |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| SEGMENT INFORMATION | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| SEGMENT INFORMATION | NOTE 24 - SEGMENT INFORMATION: The Chief Executive Officer is the Company’s Chief Operating Decision Maker (“CODM”). The CODM allocates resources and assesses the Company’s performance based on the following segmentation: Commercial Operations and Research & Development. Adjusted EBITDA represents net loss before depreciation, amortization, and financial income (expenses), adjusted to exclude share-based compensation, gains from early termination of leases, and other income, which includes income from service provided to HCRM and gain from the sale of Movantik®, and other expense from the Global Termination Agreement. The following table presents segment profitability and a reconciliation to the consolidated net income (loss) and comprehensive income (loss) for the periods indicated:
b. Major customers The following table represents the percentages of total net revenues from the major customers:
The Company’s revenues were entirely in the U.S. except for approximately $1 million from licensing revenues (including royalties) and sales of product to Gaelan in the UAE in 2024, no revenues outside the U.S. in 2023, and $2 million from licensing revenues to Gaelan in the UAE in 2022. The payment terms for all customers are 31 to 68 days. c. Assets by geographic location The Company’s non-current assets located in Israel as of December 31, 2024, amount to $6.1 million (mainly intangible assets - $5.5 million and right-of-use assets - $0.3 million). The Company’s non-current assets located in Israel as of December 31, 2023, amount to $6.4 million (mainly intangible assets - $5.6 million and right-of-use assets - $0.6 million). The remainder of the consolidated non-current assets as of December 31, 2023, amount to $0.5 million and are located in the U.S (consisting mainly right-of-use assets - $0.4 million). |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
EARNINGS (LOSS) PER ORDINARY SHARE |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||
| EARNINGS (LOSS) PER ORDINARY SHARE | |||||||||||||||||||||||||||||||||||||||||||||||||
| EARNINGS (LOSS) PER ORDINARY SHARE | NOTE 25 – EARNINGS (LOSS) PER ORDINARY SHARE:
The following is data taken into account in the computation of basic loss per share:
The Company had three categories of potentially dilutive ordinary shares: warrants issued to investors and options issued to employees and service providers. The effect of these options, RSUs and warrants for all reporting years is anti-dilutive. The calculation of diluted earnings (loss) per share as of December 31, 2024, does not include 5,606,626,800 of ordinary shares underlying warrants, 26,190,400 of ordinary shares underlying options and 377,659,600 of ordinary shares underlying RSUs, because the effect would be anti-dilutive. |
||||||||||||||||||||||||||||||||||||||||||||||||
RELATED PARTIES |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| RELATED PARTIES | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| RELATED PARTIES | NOTE 26 - RELATED PARTIES: a. Key management includes members of the Board of Directors, including the Company’s Chief Commercial Officer and Chief Executive Officer:
b. Balances with related parties:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
EVENT SUBSEQUENT TO DECEMBER 31, 2024 |
12 Months Ended | ||||||
|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | |||||||
| EVENT SUBSEQUENT TO DECEMBER 31, 2024 | |||||||
| EVENT SUBSEQUENT TO DECEMBER 31, 2024 | NOTE 27 - EVENTS SUBSEQUENT TO DECEMBER 31, 2024:
|
Insider Trading Policies and Procedures |
12 Months Ended |
|---|---|
Dec. 31, 2024 | |
| Insider Trading Policies and Procedures [Line Items] | |
| Insider Trading Policies and Procedures Adopted | true |
Cybersecurity Risk Management and Strategy Disclosure |
12 Months Ended |
|---|---|
Dec. 31, 2024 | |
| Cybersecurity Risk Management, Strategy, and Governance [Line Items] | |
| Cybersecurity Risk Management Processes for Assessing, Identifying, and Managing Threats [Text Block] | current cybersecurity risk assessment program consists of an annual review of the technical safeguards that have been implemented to ensure they align with industry best practices and evolving risks. As part of this program, we leverage the advice of -party consultants and auditors to help us assess and identify risks from cybersecurity threats, including the threat of a cybersecurity incident, and manage our risk assessment program. Among other things, these providers perform regular audits, ongoing monitoring of network traffic and system logs for suspicious activity, periodic employee training on cybersecurity best practices, and implementation of encryption protocols for sensitive data. Our cybersecurity risk assessment program outlines governance, policies and procedures and technology to oversee and identify risks from cybersecurity threats, and we are informed by previous cybersecurity incidents we have observed both within the Company and in our industry. All cyber incidents are reported to a designated RedHill email after a review by our Security Operation Center (“SOC”). Such emails contain a full description as to what has happened and how the incident was mitigated |
| Cybersecurity Risk Management Processes Integrated [Flag] | true |
| Cybersecurity Risk Management Processes Integrated [Text Block] | current cybersecurity risk assessment program consists of an annual review of the technical safeguards that have been implemented to ensure they align with industry best practices and evolving risks |
| Cybersecurity Risk Management Third Party Engaged [Flag] | true |
| Cybersecurity Risk Third Party Oversight and Identification Processes [Flag] | true |
| Cybersecurity Risk Materially Affected or Reasonably Likely to Materially Affect Registrant [Flag] | false |
| Cybersecurity Risk Board of Directors Oversight [Text Block] | Our Board of Directors is responsible for the oversight of risks from cybersecurity threats in conjunction with our Audit Committee |
| Cybersecurity Risk Board Committee or Subcommittee Responsible for Oversight [Text Block] | Board of Directors and our Audit Committee |
| Cybersecurity Risk Process for Informing Board Committee or Subcommittee Responsible for Oversight [Text Block] | Board of Directors and our Audit Committee receive from time to time reports and updates from our management with respect to the management of risks from cybersecurity threats |
| Cybersecurity Risk Role of Management [Text Block] | management, with assistance of our virtual Chief Information Security Officer (“vCISO”), is responsible for the day-to-day assessment and management of risks from cybersecurity threats, including the prevention, mitigation, detection, and remediation of cybersecurity incidents. |
| Cybersecurity Risk Management Positions or Committees Responsible [Flag] | true |
| Cybersecurity Risk Management Positions or Committees Responsible [Text Block] | management, with assistance of our virtual Chief Information Security Officer (“vCISO”), |
| Cybersecurity Risk Management Expertise of Management Responsible [Text Block] | The individuals currently serving in these roles are Razi Ingber, our CFO, and Eli Migdal, Founder and Head of Cyber Security for Migdal Computing Solutions LTD. Migdal Computing Solutions LTD also provides us with certain cybersecurity services, including vCISO, Security Operation Center, risk assessment, risk quantification, server-level penetration testing, planning, deployment and management of most modern cybersecurity solutions. Pursuant to our cybersecurity risk assessment program, our vCISO is notified about every cybersecurity event, and as the vCISO he approves the actions that were taken and transforms SOC cases to be marked as completed |
| Cybersecurity Risk Process for Informing Management or Committees Responsible [Text Block] | Pursuant to our cybersecurity risk assessment program, our vCISO is notified about every cybersecurity event, and as the vCISO he approves the actions that were taken and transforms SOC cases to be marked as completed |
| Cybersecurity Risk Management Positions or Committees Responsible Report to Board [Flag] | true |
SUMMARY OF MATERIAL ACCOUNTING POLICIES (Policies) |
12 Months Ended | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | |||||||||||||||||
| 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 IFRS Accounting Standards as issued by the International Accounting Standards Board. (“IASB”). The material accounting policies described below have been applied consistently in relation to all the periods presented, except for the adoption of IAS 1 amendments effective January 1, 2024, as described in note 2(m)(1). 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 material to the financial statements, are disclosed in note 3. Actual results could differ significantly from those estimates and assumptions. |
||||||||||||||||
| Translation of foreign currency transactions and balances | b. Translation of foreign currency transactions and balances 1) Functional and presentation currency Items included in the consolidated financial statements are measured using the currency of the primary economic environment in which the Company and its subsidiary operate (the “Functional Currency”). The consolidated financial statements are presented in U.S. dollars (“$”), which is the Company’s functional and presentation currency. 2) Transactions and balances Foreign currency transactions in currencies different from the Functional Currency (hereafter foreign currency, mostly New Israeli Shekel (“NIS”) and Euro are translated into the Functional Currency using the exchange rates at the dates of the transactions. Foreign exchange differences resulting from the settlement of such transactions and from the translation of period-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recorded in the Consolidated Statements of Comprehensive Income (Loss) under financial income or financial expenses. |
||||||||||||||||
| Trade receivables | c. Trade receivables Trade receivables are recognized initially at the amount of consideration that is unconditional. They are subsequently measured at amortized cost, less allowance for expected credit losses. The Company measures the loss allowance for expected credit losses on trade receivables based on lifetime expected credit losses. |
||||||||||||||||
| Inventory | d. Inventory The Company’s inventory is stated at the lower of cost or net realizable value. Cost of inventory is determined using the first-in, first-out method. Net realizable value is the estimated selling price in the ordinary course of business, less the estimated costs of completion and the estimated costs necessary to make the sale. 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 |
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:
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 | f. 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") which were fully derecognized in 2023 as part of the sale of the rights to Movantik® asset (See also note 15(6)). R&D assets that are available for use are stated at cost and amortized on a straight-line basis over their useful life from the time they are available for use. R&D assets that are not available for use are not amortized and are tested for impairment at least annually. Amounts due for future payments 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. |
||||||||||||||||
| Research and development | 2) Research and development Research expenses are recognized as an expense as incurred. Research and development costs for the performance of pre-clinical trials, clinical trials, and manufacturing by subcontractors are recognized as expenses when incurred. |
||||||||||||||||
| Financial liabilities | g. Financial liabilities Non-derivative financial liabilities are initially recognized at their fair value minus transaction costs and are subsequently measured at amortized cost. In case there is a difference between the fair value at initial recognition and the transaction price (“day 1 loss”), the financial liabilities are adjusted to reflect the day 1 loss and changes are recorded to profit or loss while unrecognized day 1 loss is amortized over the contractual life of the instrument. Any amounts not recognized in profit or loss before the date of exercise or maturity will be recognized in profit or loss on that date. Warrants exercisable to the Company’s ordinary shares are classified as an equity instrument only if the warrants are settled by the Company exchanging a fixed amount of cash for a fixed number of its own equity instruments (the ‘fixed for fixed’ criteria). Otherwise, the warrants are classified as a derivative financial liability measured at fair value through profit or loss. Transaction costs relating to the issuance of derivative financial liabilities measured at fair value through profit or loss are expensed to profit or loss. Financial liabilities are included in current liabilities, except for those with maturities greater than 12 months after the Statements of Financial Position date (for which they are classified as noncurrent liabilities). Financial liabilities are derecognized when, and only when, they are extinguished. The difference between the carrying amount of the financial liability extinguished and the consideration paid, including any non-cash assets transferred, is recognized in profit or loss. As for the accounting for the extinguishment of the financial liability to HCR, as well as the Global Termination Agreement which terminated all remaining credit ties related to this transaction, see note 15(6). |
||||||||||||||||
| Share-based payments | The Company operates several equity-settled, share-based compensation plans to employees 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. For employees, the total amount recognized as an expense over the vesting period of the options is determined by reference to the fair value of the options at the grant date. For service providers, the Company measures the awards based on the fair value of the asset or service received. The amounts are recorded against the accumulated deficit within equity. Vesting conditions (other than market conditions) are included in the assumptions about the number of options that are expected to vest. 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 additional paid-in capital. |
||||||||||||||||
| Revenue from contracts with customers | i. Revenue from contracts with customers The Company generated revenue in the years presented in these financial statements mainly from product sales, including in-licensed 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 Company estimates variable consideration and includes it in the transaction price 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. See also notes 3 and 13. Product returns - The Company offers customers a right of return of expired products. 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.
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. 3) Revenues from licensing Licenses of intellectual property (“IP”) rights are distinct from other promises in a contract with a customer (such as manufacturing and supply services) if the customer can benefit from the IP either on its own or together with other resources that are readily available to the customer and if the Company’s promise to license the IP is separately identifiable from other promises in the contract. If the promise to grant the license is distinct, the Company determines whether the nature of the promise in granting the license is to provide the customer with either a right to access the Company’s IP as it exists throughout the license period or a right to use the Company’s IP as it exists at the point in time at which the license is granted. Accordingly, revenue from a license providing a right of use to the Company’s IP is recognized at the point in time when control of the distinct license is transferred to the customer. Sales -based royalties that are allocated to license of IP are recognized only when (or as) the later of the following occurs: (a) the subsequent sale occurs; and (b) the performance obligation to which some or all the sales-based royalty has been allocated has been satisfied (or partially satisfied). The Company applies a practical expedient in the standard and does not adjust the transaction price for the effects of significant financing components if, at contract inception, the Company expects the period between customer payment and the transfer of goods or services to be one year or less. Revenue from achieving additional milestones is recognized only when it is highly probable that a significant reversal of cumulative revenues will not occur, usually upon achievement of the specific milestone, in accordance with the relevant agreement. |
||||||||||||||||
| Earnings (Loss) per share | j. Earnings (Loss) per share The computation of basic earnings (loss) per share is based on the Company’s earnings (loss) divided by the weighted average number of ordinary shares and pre-funded warrants outstanding during the period. In calculating the diluted earnings (loss) per share, using the treasury stock method, the Company adds the weighted average of the number of shares to be issued to the average number of shares outstanding including pre-funded warrants used to calculate the basic earnings (loss) per share, assuming all shares that have a potentially dilutive effect have been exercised into shares. |
||||||||||||||||
| Deferred taxes | k. Deferred taxes 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 | l. Leases 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 fixed lease 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, as the interest rate implicit in the lease is not readily determined. 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, the Company has elected not to separate lease and non-lease components and instead accounts for these as a single lease component. |
||||||||||||||||
| New international financial reporting standards, amendments to standards and new interpretations | m. New international financial reporting standards, amendments to standards and new interpretations:
The narrow-scope amendments to IAS 1, “Presentation of Financial Statements,” clarify that liabilities are classified as either current or noncurrent, depending on the rights that exist at the end of the reporting period. Classification is unaffected by the entity’s expectations or events after the reporting date. The amendments also clarify what IAS 1 means when it refers to the settlement’ of a liability. The amendments may affect the classification of liabilities, particularly for entities that previously considered management’s intentions to determine classification and for some liabilities that can be converted into equity. The Company adopted these amendments effective January 1, 2024. The impact on the Company’s financial statements of these amendments was the reclassification of the Company’s derivative financial instruments from non-current to current as of its effective date, as the Company does not have the right to defer settlement of liability for at least twelve months after the reporting period. The Company has retrospectively applied the amendments in these interim financial statements and, accordingly, has retrospectively adjusted the comparative balance sheet for December 31, 2023, to reclassify its warrant liabilities ($741 as of December 31, 2023) from non-current to current. Adoption of the amendments had no other impact on the Company’s financial statements.
This standard replaces the international accounting standard IAS 1, “Presentation of Financial Statements.” As part of the new disclosure requirements, companies will be required to present new defined subtotals in the statements of income, as follows: (1) operating profit and (2) profit before financing and tax. In addition, income statement items will be classified into three defined categories: operating, investment and financing. The standard also includes a requirement to provide a separate disclosure in the financial statements regarding the use of management-defined performance measures (“non-GAAP measures”), and specific instructions were added for the grouping and splitting of items in the financial statements and in the notes to the financial statements. IFRS 18 is effective for annual reporting periods beginning on or after January 1, 2027, with an option for early adoption. |
SUMMARY OF MATERIAL ACCOUNTING POLICIES (Tables) |
12 Months Ended | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | |||||||||||||||||
| SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |||||||||||||||||
| Schedule of estimated useful lives of fixed assets |
|
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| FINANCIAL INSTRUMENTS | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of company's financial liabilities and estimated maturities |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of change in derivative financial instrument |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of reconciliation of liabilities arising from financing activities |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
CASH AND CASH EQUIVALENTS (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | ||||||||||||||||||||||||||||||||||||
| CASH AND CASH EQUIVALENTS. | ||||||||||||||||||||||||||||||||||||
| Schedule of cash and cash equivalents |
|
|||||||||||||||||||||||||||||||||||
PREPAID EXPENSES AND OTHER RECEIVABLES (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||
| PREPAID EXPENSES AND OTHER RECEIVABLES | |||||||||||||||||||||||||||||||||||||||||
| Schedule of prepaid expenses and other receivables |
|
||||||||||||||||||||||||||||||||||||||||
INVENTORY (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||
| INVENTORY | |||||||||||||||||||||||||||||||||||||||||
| Schedule of Inventory |
|
||||||||||||||||||||||||||||||||||||||||
FIXED ASSETS (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| FIXED ASSETS | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of composition of assets and accumulated depreciation, grouped by major classifications |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
LEASES (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| GENERAL | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of amounts recognized for leases |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
INTANGIBLE ASSETS (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| INTANGIBLE ASSETS | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of intangible assets changes |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||
| ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | ||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of accrued expenses and other current liabilities |
|
|||||||||||||||||||||||||||||||||||||||||||||
ALLOWANCE FOR DEDUCTIONS FROM REVENUES (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ALLOWANCE FOR DEDUCTIONS FROM REVENUES | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of movement of allowance for deductions from revenue |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
SHARE CAPITAL (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||
| SHARE CAPITAL | ||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of composition of share capital |
|
|||||||||||||||||||||||||||||||||||||||||||||
SHARE-BASED PAYMENTS (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| SHARE-BASED PAYMENTS | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of number of shares and weighted averages of exercise prices |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of expenses recognized in profit or loss |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
NET REVENUES (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| NET REVENUES | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of net revenues |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RESEARCH AND DEVELOPMENT EXPENSES (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| RESEARCH AND DEVELOPMENT EXPENSES. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of research and development expenses |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
SELLING AND MARKETING EXPENSES (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| SELLING AND MARKETING EXPENSES | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of selling, marketing and business development expenses |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
GENERAL AND ADMINISTRATIVE EXPENSES (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| GENERAL AND ADMINISTRATIVE EXPENSES | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of general and administrative expenses |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
FINANCIAL INCOME (EXPENSES), net (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| FINANCIAL INCOME (EXPENSES), net | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of financial income (expenses), net |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
SEGMENT INFORMATION (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| SEGMENT INFORMATION | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of segment profitability and reconciliation to consolidated net income (loss) and comprehensive income (loss) |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of percentages of total net revenues from major customers |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
EARNINGS (LOSS) PER ORDINARY SHARE (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||
| EARNINGS (LOSS) PER ORDINARY SHARE | |||||||||||||||||||||||||||||||||||||||||||
| Schedule of earnings (loss) per share |
|
||||||||||||||||||||||||||||||||||||||||||
RELATED PARTIES (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| RELATED PARTIES | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of key management compensation: |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of balances with related parties |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
GENERAL (Details) - shares |
Aug. 20, 2024 |
Mar. 23, 2023 |
|---|---|---|
| ADS | ||
| General [Line Items] | ||
| Number of Ordinary Shares Issued in Exchange of American Depository Receipts | 10 | |
| New ADS Ratio [Member] | ||
| General [Line Items] | ||
| Number of Ordinary Shares Issued in Exchange of American Depository Receipts | 10,000 | 400 |
SUMMARY OF MATERIAL ACCOUNTING POLICIES (Details) - USD ($) $ in Thousands |
12 Months Ended | |
|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
|
| Accounting Policies [Line Items] | ||
| Warrant liabilities | $ 1,421 | $ 741 |
| IAS 1 Amendments | Warrants | ||
| Accounting Policies [Line Items] | ||
| Warrant liabilities | $ 741 | |
| Computer equipment | ||
| Accounting Policies [Line Items] | ||
| Depreciation rate, property, plant and equipment | 33.00% | |
| Office furniture and equipment | Minimum | ||
| Accounting Policies [Line Items] | ||
| Depreciation rate, property, plant and equipment | 8.00% | |
| Office furniture and equipment | Maximum | ||
| Accounting Policies [Line Items] | ||
| Depreciation rate, property, plant and equipment | 15.00% |
CRITICAL ACCOUNTING ESTIMATES AND JUDGMENTS (Details) |
12 Months Ended |
|---|---|
|
Dec. 31, 2024
USD ($)
| |
| Disclosure of significant unobservable inputs used in fair value measurement of assets [line items] | |
| Discount rate applied to risk-adjusted cash flows | 18.10% |
| Intangible R&D Assets [member] | |
| Disclosure of significant unobservable inputs used in fair value measurement of assets [line items] | |
| Impairment loss | $ 0 |
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT (Details) $ in Thousands |
12 Months Ended | |
|---|---|---|
|
Dec. 31, 2024
USD ($)
item
|
Dec. 31, 2023
USD ($)
|
|
| Financial instruments | ||
| Number of major U.S. wholesalers. | item | 3 | |
| Trade receivable member | Impairment | ||
| Financial instruments | ||
| Trade receivables | $ | $ 0 | $ 0 |
| Maximum | ||
| Financial instruments | ||
| Maturity periods for cash balances in highly-rated bank deposits | 1 year | |
| Market risk [member] | U.S. dollar | ||
| Financial instruments | ||
| Percentage of currency stronger against the NIS | 5.00% |
CASH AND CASH EQUIVALENTS (Details) - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Dec. 31, 2021 |
|---|---|---|---|---|
| CASH AND CASH EQUIVALENTS. | ||||
| Cash in bank | $ 1,882 | $ 5,569 | ||
| Short-term bank deposits | 2,735 | |||
| Cash and cash equivalents | $ 4,617 | $ 5,569 | $ 19,968 | $ 29,474 |
PREPAID EXPENSES AND OTHER RECEIVABLES (Details) - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
|---|---|---|
| PREPAID EXPENSES AND OTHER RECEIVABLES | ||
| Advance to suppliers | $ 77 | $ 1,310 |
| Government institutions | 334 | 694 |
| Prepaid expenses and others | 693 | 797 |
| Total prepaid expenses and other receivables | $ 1,104 | $ 2,801 |
INVENTORY (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
| Disclosure of information related to Inventory [Line Item] | |||
| Raw materials | $ 513 | $ 828 | |
| Work in progress | 308 | 233 | |
| Finished goods | 2,830 | 3,328 | |
| Total inventory | 3,651 | 4,389 | |
| Cost of sales [member] | |||
| Disclosure of information related to Inventory [Line Item] | |||
| Inventory recognized as part of cost of revenues | 3,400 | 4,400 | $ 9,700 |
| Inventory write-down | $ 200 | $ 1,300 | $ 2,400 |
FIXED ASSETS (Details) - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
|---|---|---|
| Fixed assets | ||
| Fixed assets | $ 135 | $ 193 |
| Cost | ||
| Fixed assets | ||
| Fixed assets | 1,447 | 1,438 |
| Accumulated amortization | ||
| Fixed assets | ||
| Fixed assets | (1,312) | (1,245) |
| Office furniture and equipment (including computers) | ||
| Fixed assets | ||
| Fixed assets | 80 | 103 |
| Office furniture and equipment (including computers) | Cost | ||
| Fixed assets | ||
| Fixed assets | 1,068 | 1,059 |
| Office furniture and equipment (including computers) | Accumulated amortization | ||
| Fixed assets | ||
| Fixed assets | (988) | (956) |
| Leasehold improvements | ||
| Fixed assets | ||
| Fixed assets | 55 | 90 |
| Leasehold improvements | Cost | ||
| Fixed assets | ||
| Fixed assets | 379 | 379 |
| Leasehold improvements | Accumulated amortization | ||
| Fixed assets | ||
| Fixed assets | $ (324) | $ (289) |
LEASES (Details) - USD ($) $ in Thousands |
1 Months Ended | 12 Months Ended | ||
|---|---|---|---|---|
Jun. 30, 2023 |
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
| Right-of-use assets: | ||||
| Right-of-use assets | $ 302 | $ 989 | ||
| Lease liabilities: | ||||
| Current | 353 | 718 | ||
| Non-current | 3 | 455 | ||
| Lease liabilities | 356 | 1,173 | ||
| Additions to right-of-use assets | 300 | |||
| Additions to lease liabilities | 300 | |||
| Decrease in lease liabilities | 200 | 5,400 | ||
| Decrease in right o fuse assets | 166 | 4,697 | ||
| Depreciation charge of right-of-use assets | 521 | 1,276 | ||
| Interest expense | 55 | 367 | $ 430 | |
| Foreign exchange differences | 7 | 3 | ||
| Cash outflow for leases | 700 | 1,500 | ||
| Gain On Termination Of Operating Lease Agreement | $ 700 | |||
| Properties | ||||
| Right-of-use assets: | ||||
| Right-of-use assets | 302 | 773 | ||
| Lease liabilities: | ||||
| Depreciation charge of right-of-use assets | 470 | 798 | ||
| Vehicles | ||||
| Right-of-use assets: | ||||
| Right-of-use assets | 216 | |||
| Lease liabilities: | ||||
| Depreciation charge of right-of-use assets | $ 51 | $ 478 | ||
INTANGIBLE ASSETS - Narrative (Details) |
12 Months Ended |
|---|---|
Dec. 31, 2024 | |
| Talicia | |
| Reconciliation of changes in intangible assets | |
| Useful life of assets (in years) | 15 years |
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT (Details) - USD ($) |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
| LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT | |||
| Defined contribution plans expense | $ 156,000 | $ 206,000 | $ 261,000 |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Details) - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
|---|---|---|
| ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | ||
| Accrued expenses | $ 2,698 | $ 3,765 |
| Payable in respect to the Global Termination Agreement (see note 15(6)(b)) | 6,693 | |
| Employees and related liabilities | 510 | 727 |
| Government institutions | 92 | 100 |
| Accrued expenses and other current liabilities | $ 9,993 | $ 4,592 |
ALLOWANCE FOR DEDUCTIONS FROM REVENUES (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
| Disclosure of other provisions [line items] | |||
| Balance at Beginning of period | $ 10,654 | $ 47,870 | $ 30,711 |
| Increases | 9,971 | 22,084 | 126,425 |
| Decreases (Utilized) | (12,923) | (63,467) | (110,723) |
| Adjustments | 1,586 | 4,167 | 1,457 |
| Balance at end of period | 9,288 | 10,654 | 47,870 |
| Rebates and patient discount programs | |||
| Disclosure of other provisions [line items] | |||
| Balance at Beginning of period | 8,087 | 46,636 | 29,742 |
| Increases | 9,712 | 21,225 | 123,878 |
| Decreases (Utilized) | (10,423) | (60,498) | (108,531) |
| Adjustments | 487 | 724 | 1,547 |
| Balance at end of period | 7,863 | 8,087 | 46,636 |
| Product returns | |||
| Disclosure of other provisions [line items] | |||
| Balance at Beginning of period | 2,567 | 1,234 | 969 |
| Increases | 259 | 859 | 2,547 |
| Decreases (Utilized) | (2,500) | (2,969) | (2,192) |
| Adjustments | 1,099 | 3,443 | (90) |
| Balance at end of period | $ 1,425 | $ 2,567 | $ 1,234 |
COMMITMENTS - Movantik Acquisition (Details) - USD ($) $ in Thousands |
Apr. 01, 2020 |
Dec. 31, 2024 |
Dec. 31, 2023 |
|---|---|---|---|
| Disclosure of detailed information about intangible assets [line items] | |||
| Intangible assets | $ 5,547 | $ 5,578 | |
| Movantik | |||
| Disclosure of detailed information about intangible assets [line items] | |||
| Intangible assets | $ 65,000 | ||
| Useful life of assets (in years) | 12 years 6 months |
INCOME TAX (Details) - USD ($) $ in Millions |
12 Months Ended | |
|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
|
| Income Tax [Line Items] | ||
| Deductible temporary differences | $ 3 | $ 6 |
| Israel | ||
| Income Tax [Line Items] | ||
| Corporate tax rate | 23.00% | |
| Israel | No Expiration [member] | ||
| Income Tax [Line Items] | ||
| Net operating losses | $ 350 | |
| U.S. | ||
| Income Tax [Line Items] | ||
| Corporate tax rate | 21.00% | |
| Net operating losses | $ 45 |
SHARE-BASED PAYMENTS - Number of Options and Weighted Averages of Exercise Prices (Details) |
12 Months Ended | |||||
|---|---|---|---|---|---|---|
|
Dec. 31, 2024
Option
$ / shares
|
Dec. 31, 2024
Option
$ / shares
|
Dec. 31, 2024
shares
Option
$ / shares
|
Dec. 31, 2023
Option
$ / shares
|
Dec. 31, 2023
Option
$ / shares
|
Dec. 31, 2023
Option
shares
$ / shares
|
|
| SHARE-BASED PAYMENTS | ||||||
| Number of options, outstanding at beginning of year | 3,894 | 3,894 | 5,259 | |||
| Number of options, expired and forfeited | Option | (1,275) | (1,365) | ||||
| Number of options, outstanding at end of year | 2,619 | 2,619 | 3,894 | 3,894 | ||
| Number of options, exercisable at end of year | Option | 2,525 | 2,525 | 2,525 | 3,455 | 3,455 | 3,455 |
| Weighted average of exercise price, outstanding at beginning of year | $ 6,324.5 | $ 6,390 | ||||
| Weighted average of exercise price, expired and forfeited | 6,277.89 | 6,560.75 | ||||
| Weighted average of exercise price, outstanding at end of year | 6,329.96 | 6,324.5 | ||||
| Weighted average of exercise price, exercisable at end of year | $ 6,310.15 | $ 6,310.15 | $ 6,310.15 | $ 6,228.5 | $ 6,228.5 | $ 6,228.5 |
SHARE-BASED PAYMENTS - Number of RSUs (Details) - shares |
12 Months Ended | |
|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
|
| SHARE-BASED PAYMENTS | ||
| Number of RSUs, Outstanding at beginning of year | 7,121 | 3,646 |
| Number of RSUs, Exercised | (23,938) | (2,658) |
| Number of RSUs, Expired and forfeited | (2,497) | (1,367) |
| Number of RSUs, Granted | 57,080 | 7,500 |
| Number of RSUs, Outstanding at end of year | 37,766 | 7,121 |
SHARE-BASED PAYMENTS - Information About Exercise Price and Remaining Useful Life of Outstanding Options (Details) |
12 Months Ended | ||||||
|---|---|---|---|---|---|---|---|
|
Dec. 31, 2024
Option
|
Dec. 31, 2023
Option
|
Dec. 31, 2024
shares
|
Dec. 31, 2024
$ / shares
|
Dec. 31, 2023
shares
|
Dec. 31, 2023
$ / shares
|
Dec. 31, 2022
Option
|
|
| Disclosure of number and weighted average remaining contractual life of outstanding share options [line items] | |||||||
| Number of options outstanding at end of Year | 2,619 | 3,894 | 2,619 | 3,894 | 5,259 | ||
| Weighted average of remaining useful life | 5 years 15 days | 5 years 2 months | |||||
| Minimum | |||||||
| Disclosure of number and weighted average remaining contractual life of outstanding share options [line items] | |||||||
| Exercise price range | $ 1,670 | $ 1,670 | |||||
| Maximum | |||||||
| Disclosure of number and weighted average remaining contractual life of outstanding share options [line items] | |||||||
| Exercise price range | $ 10,370 | $ 10,900 | |||||
SHARE-BASED PAYMENTS - Expenses Recognized in Profit or Loss (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
| SHARE-BASED PAYMENTS | |||
| Expenses recognized in profit or loss | $ 665 | $ 1,647 | $ 5,675 |
| Unrecognized compensation expenses | $ 200 | ||
NET REVENUES (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
| Revenues | |||
| Licensing revenue | $ 547 | $ 2,000 | |
| Sale of products | 7,496 | $ 6,530 | 59,800 |
| Revenue | 8,043 | 6,530 | 61,800 |
| Talicia | |||
| Revenues | |||
| Revenue | 8,400 | 9,100 | 7,700 |
| Talicia | Gaelan Medical Trade LLC | |||
| Revenues | |||
| Licensing revenue | 2,000 | ||
| Movantik | |||
| Revenues | |||
| Revenue | $ 52,100 | ||
| Contra Revenue For Movantik | $ (900) | $ (2,600) | |
RESEARCH AND DEVELOPMENT EXPENSES (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
| Research And Development Expenses Net [Line Items] | |||
| Research and development expenses | $ 1,588 | $ 3,528 | $ 7,279 |
| Payroll and related expenses | |||
| Research And Development Expenses Net [Line Items] | |||
| Research and development expenses | 222 | 390 | 661 |
| Professional services | |||
| Research And Development Expenses Net [Line Items] | |||
| Research and development expenses | 708 | 605 | 1,210 |
| Share-based payments | |||
| Research And Development Expenses Net [Line Items] | |||
| Research and development expenses | 156 | 138 | 1,151 |
| Clinical and pre-clinical trials | |||
| Research And Development Expenses Net [Line Items] | |||
| Research and development expenses | 114 | 1,891 | 3,872 |
| Intellectual property development | |||
| Research And Development Expenses Net [Line Items] | |||
| Research and development expenses | 238 | 222 | 180 |
| Other | |||
| Research And Development Expenses Net [Line Items] | |||
| Research and development expenses | $ 150 | $ 282 | $ 205 |
GENERAL AND ADMINISTRATIVE EXPENSES (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
| General And Administrative Expense [Line Items] | |||
| General and administrative expenses | $ 9,567 | $ 16,219 | $ 28,586 |
| Payroll and related expenses | |||
| General And Administrative Expense [Line Items] | |||
| General and administrative expenses | 4,515 | 7,035 | 10,521 |
| Share-based payments | |||
| General And Administrative Expense [Line Items] | |||
| General and administrative expenses | 550 | 1,560 | 3,971 |
| Professional services and supply chain | |||
| General And Administrative Expense [Line Items] | |||
| General and administrative expenses | 3,118 | 5,391 | 10,787 |
| Medical affairs | |||
| General And Administrative Expense [Line Items] | |||
| General and administrative expenses | 131 | 818 | 1,214 |
| Office-related expenses | |||
| General And Administrative Expense [Line Items] | |||
| General and administrative expenses | 749 | 958 | 1,434 |
| Other | |||
| General And Administrative Expense [Line Items] | |||
| General and administrative expenses | $ 504 | $ 457 | $ 659 |
SEGMENT INFORMATION - Major Customers and Segment Assets (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
| Disclosure of major customers | |||
| Revenue | $ 8,043 | $ 6,530 | $ 61,800 |
| UAE | Gaelan | |||
| Disclosure of major customers | |||
| Revenue | $ 1,000 | $ 2,000 | |
| Outside the united states | |||
| Disclosure of major customers | |||
| Revenue | $ 0 | ||
| Minimum | |||
| Disclosure of major customers | |||
| Payment Terms For Customers | 31 days | ||
| Maximum | |||
| Disclosure of major customers | |||
| Payment Terms For Customers | 68 days | ||
| Customer A | |||
| Disclosure of major customers | |||
| Percentage of revenue | 36.00% | 30.00% | 32.00% |
| Customer B | |||
| Disclosure of major customers | |||
| Percentage of revenue | 22.00% | 28.00% | 30.00% |
| Customer C | |||
| Disclosure of major customers | |||
| Percentage of revenue | 30.00% | 37.00% | 33.00% |
SEGMENT INFORMATION - Assets by geographic location (Details) - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
|---|---|---|
| Disclosure of geographical areas [line items] | ||
| Non-current assets | $ 6,132 | $ 6,907 |
| Intangible assets | 5,547 | 5,578 |
| Right-of-use assets | 302 | 989 |
| Israel | ||
| Disclosure of geographical areas [line items] | ||
| Non-current assets | 6,100 | 6,400 |
| Intangible assets | 5,500 | 5,600 |
| Right-of-use assets | $ 300 | 600 |
| U.S. | ||
| Disclosure of geographical areas [line items] | ||
| Non-current assets | 500 | |
| Right-of-use assets | $ 400 |
EARNINGS (LOSS) PER ORDINARY SHARE - Basic (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
| Basic | |||
| Earnings (Loss) (U.S. dollars in thousands) | $ (8,268) | $ 23,916 | $ (71,669) |
| Weighted average number of ordinary shares outstanding during the period (in thousands) | 12,322,721 | 2,591,222 | 616,299 |
| Basic earnings (loss) per share (U.S. dollars) | $ 0 | $ 0.01 | $ (0.12) |
RELATED PARTIES - Key Management Compensation (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
|---|---|---|---|
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
|
| RELATED PARTIES | |||
| Salaries and other short-term employee benefits | $ 1,030 | $ 1,189 | $ 1,486 |
| Post-employment benefits | 49 | 56 | 64 |
| Share-based payments | 205 | 407 | 1,041 |
| Other long-term benefits | $ 31 | $ 35 | $ 44 |
RELATED PARTIES - Balances with Related Parties (Details) - USD ($) $ in Thousands |
Dec. 31, 2024 |
Dec. 31, 2023 |
|---|---|---|
| Current liabilities | ||
| Credit balance in "accrued expenses and other current liabilities" | $ 176 | $ 206 |
EVENTS SUBSEQUENT TO DECEMEBER 31, 2024 (Details) - USD ($) $ / shares in Units, $ in Thousands |
12 Months Ended | ||||||
|---|---|---|---|---|---|---|---|
Apr. 10, 2025 |
Feb. 24, 2025 |
Apr. 03, 2024 |
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Jul. 25, 2023 |
|
| Disclosure of non-adjusting events after reporting period [line items] | |||||||
| Number of shares issued | 52,077 | ||||||
| Proceeds from issue of ordinary shares | $ 1,250 | $ 8,263 | $ 13,959 | $ 23,806 | |||
| Number of ADSs shares sold | 453,345 | ||||||
| Purchase price (per share) | $ 4.96 | ||||||
| Proceeds from issuance of shares | $ 2,200 | ||||||
| Upfront payments received | $ 100 | ||||||
| Maximum | |||||||
| Disclosure of non-adjusting events after reporting period [line items] | |||||||
| Gross consideration | $ 3,500 | ||||||
| maximum eligible milestone payments | $ 60,000 | ||||||