Document and Entity Information
Document and Entity Information | 12 Months Ended |
Dec. 31, 2023 shares | |
Document Information [Line Items] | |
Document Type | 20-F |
Document Registration Statement | false |
Document Annual Report | true |
Document Period End Date | Dec. 31, 2023 |
Document Transition Report | false |
Document Shell Company Report | false |
Entity File Number | 001-35773 |
Entity Registrant Name | RedHill Biopharma Ltd. |
Entity Incorporation, State or Country Code | L3 |
Entity Address, Address Line One | 21 Ha’arba’a Street |
Entity Address, City or Town | Tel Aviv |
Entity Address, Postal Zip Code | 6473921 |
Entity Address, Country | IL |
Entity Common Stock, Shares Outstanding | 12,746,797,800 |
Entity Well-known Seasoned Issuer | No |
Entity Voluntary Filers | No |
Entity Current Reporting Status | Yes |
Entity Interactive Data Current | Yes |
Entity Filer Category | Non-accelerated Filer |
Entity Emerging Growth Company | false |
ICFR Auditor Attestation Flag | true |
Document Financial Statement Error Correction [Flag] | false |
Document Accounting Standard | International Financial Reporting Standards |
Entity Shell Company | false |
Auditor Name | Kesselman & Kesselman |
Auditor Location | Tel-Aviv, Israel |
Auditor Firm ID | 1309 |
Entity Central Index Key | 0001553846 |
Current Fiscal Year End Date | --12-31 |
Document Fiscal Year Focus | 2023 |
Document Fiscal Period Focus | FY |
Amendment Flag | false |
ADS | |
Document Information [Line Items] | |
Title of 12(b) Security | American Depositary Shares, each representing four hundred (400) Ordinary Shares (1) |
Trading Symbol | RDHL |
Security Exchange Name | NASDAQ |
Ordinary shares | |
Document Information [Line Items] | |
Title of 12(b) Security | Ordinary Shares, par value NIS 0.01 per share (2) |
Business contact | |
Document Information [Line Items] | |
Contact Personnel Name | Razi Ingber |
Entity Address, Address Line One | 21 Ha’arba’a Street |
Entity Address, City or Town | Tel Aviv |
Entity Address, Postal Zip Code | 6473921 |
Entity Address, Country | IL |
City Area Code | 972 |
Local Phone Number | 3-541-3131 |
Contact Personnel Fax Number | 972-3-541-3144 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | |||
NET REVENUES | $ 6,530 | $ 61,800 | $ 85,757 |
COST OF REVENUES | 3,459 | 33,337 | 49,406 |
GROSS PROFIT | 3,071 | 28,463 | 36,351 |
RESEARCH AND DEVELOPMENT EXPENSES | 3,528 | 7,279 | 29,498 |
SELLING AND MARKETING EXPENSES | 14,756 | 35,442 | 55,623 |
GENERAL AND ADMINISTRATIVE EXPENSES | 16,219 | 28,586 | 32,365 |
OTHER INCOME | (44,064) | ||
OPERATING INCOME (LOSS) | 12,632 | (42,844) | (81,135) |
FINANCIAL INCOME | 20,889 | 13,562 | 51 |
FINANCIAL EXPENSES | 9,605 | 42,387 | 16,660 |
FINANCIAL INCOME (EXPENSES), net | 11,284 | (28,825) | (16,609) |
INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS) FOR THE PERIOD | $ 23,916 | $ (71,669) | $ (97,744) |
EARNINGS (LOSS) PER ORDINARY SHARE, basic (U.S. dollars) | $ 0.01 | $ (0.12) | $ (0.21) |
EARNINGS (LOSS) PER ORDINARY SHARE, diluted (U.S. dollars) | $ 0.01 | $ (0.12) | $ (0.21) |
CONSOLIDATED STATEMENTS OF FINA
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 5,569 | $ 19,968 |
Bank deposits | 15 | |
Restricted cash | 790 | 16,000 |
Trade receivables | 2,591 | 34,521 |
Prepaid expenses and other receivables | 2,801 | 4,387 |
Inventory | 4,389 | 11,009 |
Total current assets | 16,140 | 85,900 |
NON-CURRENT ASSETS: | ||
Restricted cash | 147 | 150 |
Fixed assets | 193 | 502 |
Right-of-use assets | 989 | 6,692 |
Intangible assets | 5,578 | 65,626 |
Total non-current assets | 6,907 | 72,970 |
TOTAL ASSETS | 23,047 | 158,870 |
CURRENT LIABILITIES: | ||
Account payable | 3,278 | 4,230 |
Lease liabilities | 718 | 1,032 |
Allowance for deductions from revenue | 10,654 | 47,870 |
Accrued expenses and other current liabilities | 4,592 | 17,949 |
Borrowing | 115,216 | |
Payable in respect of intangible assets purchase | 11,157 | |
Total current liabilities | 19,242 | 197,454 |
NON-CURRENT LIABILITIES: | ||
Lease liabilities | 455 | 6,443 |
Derivative financial instruments | 741 | 2,623 |
Royalty obligation | 540 | 750 |
Total non-current liabilities | 1,736 | 9,816 |
TOTAL LIABILITIES | 20,978 | 207,270 |
EQUITY (Capital Deficiency): | ||
Ordinary shares | 21,441 | 2,835 |
Additional paid-in capital | 388,363 | 382,625 |
Accumulated deficit | (407,735) | (433,860) |
TOTAL EQUITY (Capital Deficiency) | 2,069 | (48,400) |
TOTAL LIABILITIES AND EQUITY (Capital Deficiency) | $ 23,047 | $ 158,870 |
CONSOLIDATED STATEMENTS OF CHAN
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY (CAPITAL DEFICIENCY) - USD ($) $ in Thousands | Ordinary shares. | Additional paid-in capital | Accumulated deficit | Total |
Balance at beginning of period at Dec. 31, 2020 | $ 1,054 | $ 293,144 | $ (280,334) | $ 13,864 |
Share-based compensation to employees and service providers | 10,212 | 10,212 | ||
Issuance of ordinary shares and warrants, net of expenses | 424 | 78,113 | 78,537 | |
Exercise of options into ordinary shares | 17 | 3,989 | 4,006 | |
Comprehensive income (loss) | (97,744) | (97,744) | ||
Balance at end of period at Dec. 31, 2021 | 1,495 | 375,246 | (367,866) | 8,875 |
Share-based compensation to employees and service providers | 5,675 | 5,675 | ||
Issuance of ordinary shares and warrants, net of expenses | 1,326 | 7,393 | 8,719 | |
Issuance Of Ordinary Shares For Vested RSUs | 14 | (14) | ||
Comprehensive income (loss) | (71,669) | (71,669) | ||
Balance at end of period at Dec. 31, 2022 | 2,835 | 382,625 | (433,860) | (48,400) |
Share-based compensation to employees and service providers | 2,209 | 2,209 | ||
Issuance of ordinary shares and warrants, net of expenses | 18,556 | 5,788 | 24,344 | |
Issuance Of Ordinary Shares For Vested RSUs | 50 | (50) | ||
Comprehensive income (loss) | 23,916 | 23,916 | ||
Balance at end of period at Dec. 31, 2023 | $ 21,441 | $ 388,363 | $ (407,735) | $ 2,069 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
OPERATING ACTIVITIES: | |||
Comprehensive income (loss) | $ 23,916,000 | $ (71,669,000) | $ (97,744,000) |
Adjustments in respect of income and expenses not involving cash flow: | |||
Share-based compensation to employees and service providers | 1,647,000 | 5,675,000 | 10,212,000 |
Depreciation | 1,445,000 | 2,136,000 | 1,914,000 |
Amortization of intangible assets | 545,000 | 6,018,000 | 16,235,000 |
Adjustments For Gains From The Transfer Of Rights In Movantik And Extinguishment Of Debt Obligations | (56,082,000) | ||
Adjustments For Gains From Early Termination Of Leases Net | (543,000) | ||
Non-cash expenses related to borrowing and payable in respect of intangible assets purchase | 33,151,000 | 5,366,000 | |
Fair value gains on derivative financial instruments and changes in royalty obligation | 5,359,000 | (13,422,000) | 5,000 |
Adjustments For Loss From Modification Of Warrants Terms As Part Of A New Issuance. | 1,459,000 | ||
Adjustment For Issuance Cost In respect Of Warrants | 2,034,000 | 958,000 | |
Exchange differences and revaluation of bank deposits | 19,000 | (40,000) | 118,000 |
Total adjustments in respect of income and expenses not involving cash flow | (44,117,000) | 34,476,000 | 33,850,000 |
Changes in assets and liability items: | |||
Decrease (increase) in trade receivables | 31,930,000 | (2,845,000) | (3,021,000) |
Decrease in prepaid expenses and other receivables | 1,586,000 | 274,000 | 860,000 |
Decrease (increase) in inventories | 2,387,000 | 3,801,000 | (8,285,000) |
Increase (decrease) in accounts payable | (952,000) | (7,434,000) | 111,000 |
(Decrease) in accrued expenses and other liabilities | (13,354,000) | (2,947,000) | (3,186,000) |
Increase (decrease) in allowance for deductions from revenue | (37,216,000) | 17,159,000 | 12,368,000 |
Total changes in assets and liability items | (15,619,000) | 8,008,000 | (1,153,000) |
Net cash used in operating activities | (35,820,000) | (29,185,000) | (65,047,000) |
INVESTING ACTIVITIES: | |||
Purchase of fixed assets | (11,000) | (198,000) | (115,000) |
Change In Investment In Current Bank Deposits Classed As Investing Activities | 15,000 | 8,500,000 | (8,500,000) |
Proceeds from sale of financial assets at fair value through profit or loss | 475,000 | ||
Net cash provided by investing activities | 4,000 | 8,302,000 | (8,140,000) |
FINANCING ACTIVITIES: | |||
Proceeds from issuance of ordinary shares and warrants, net of issuance costs | 13,959,000 | 23,806,000 | 78,536,000 |
Proceeds from exercise of options | 4,006,000 | ||
Repayment of payable in respect of intangible asset purchase | (6,555,000) | (10,878,000) | (7,397,000) |
Decrease in restricted cash | 15,210,000 | ||
Payment of principal with respect to lease liabilities | (1,175,000) | (1,475,000) | (1,683,000) |
Net cash provided by provided by financing activities | 21,439,000 | 11,453,000 | 73,462,000 |
DECREASE IN CASH AND CASH EQUIVALENTS | (14,377,000) | (9,430,000) | 275,000 |
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS | (22,000) | (76,000) | (96,000) |
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 19,968,000 | 29,474,000 | 29,295,000 |
BALANCE OF CASH AND CASH EQUIVALENTS AT THE END OF PERIOD | 5,569,000 | 19,968,000 | 29,474,000 |
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH | 138,000 | 84,000 | 47,000 |
SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH | 367,000 | 8,182,000 | 11,280,000 |
Acquisition of right-of-use assets by means of lease liabilities | 270,000 | 5,590,000 | $ 303,000 |
Decrease in lease liability (with corresponding decrease in right of use asset in amount of $4,117) resulting from early termination of lease | 5,413,000 | $ 587,000 | |
Decrease in Intangible asset | (59,503,000) | ||
Decrease in Inventories | (4,233,000) | ||
Decrease in Payable in respect of Intangible asset | 4,602,000 | ||
Decrease in Borrowing | 115,216,000 | ||
Gains From The Transfer Of The Rights In Movantik And Extinguishment Of Debt Obligations | $ 56,082,000 |
CONSOLIDATED STATEMENTS OF CA_2
CONSOLIDATED STATEMENTS OF CASH FLOWS (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
CONSOLIDATED STATEMENTS OF CASH FLOWS | ||
Decrease in right of use asset | $ 4,697 | $ 534 |
GENERAL
GENERAL | 12 Months Ended |
Dec. 31, 2023 | |
GENERAL | |
GENERAL | NOTE 1 - GENERAL: a. General: 1) The Company’s ordinary shares were traded on the Tel-Aviv Stock Exchange (“TASE”) from February 2011 to February 2020, after which the Company voluntarily delisted from trading on the TASE, effective February 13, 2020. The Company’s American Depositary Shares (“ADSs”) were traded on the Nasdaq Capital Market from December 27, 2012, 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 implemented a ratio change of the Company's ADSs to its non-traded ordinary shares from ratio of 1 ADS representing 10 ordinary shares to a new ratio of 1 ADS representing 400 ordinary shares. The Company’s registered address is 21 Ha’arba’a St, Tel-Aviv, Israel . 2) Since the Company established its commercial presence in the U.S. in 2017, it has promoted or commercialized various GI-related products that were either developed internally or acquired through in-licensing agreements. As of the date of approval of these financial statements, the Company commercializes in the U.S. mainly Talicia®, for the treatment of Helicobacter pylori infection in adults, the first product approved by the U.S. Food and Drug Administration (“FDA”) being developed primarily internally by the Company. Until February 1, 2023, the Company commercialized Movantik® in the U.S, for the treatment of opioid-induced constipation. See also note 15 (6) regarding the transfer of the Company’s rights in Movantik® to HCR Collateral Management, LLC (“HCRM”) in exchange for all the Company’s debt obligations under the Credit Agreement with HCRM. The Company also continues to advance the development part of its late-stage therapeutic candidates. 3) The Company plans to further fund its future operations through commercialization and out-licensing of its therapeutic candidates, commercialization of in-licensed or acquired products and raising additional capital through equity or debt financing or through other non-dilutive financing. Furthermore, the Company is actively pursuing and in discussions with multiple parties regarding strategic business development transactions, including potential divestment of certain of the Company’s assets and/or its commercial operations, which the Company expects would provide it with additional capital although there is no guarantee that the Company will complete such a transaction on favorable terms . NOTE 1 - GENERAL : 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) b. Approval of the financial statements: The date of the approval of these financial statements by the Board of Directors (the "BoD") is April 8, 2024. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2023 | |
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 International Financial Reporting Standards (“IFRS”), 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, unless otherwise stated. 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. NOTE 2 - SUMMARY OF MATERIAL ACCOUNTING POLICIES : 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. Fixed assets items are stated at cost less accumulated depreciation. Depreciation is computed by the straight-line method, to reduce the cost of fixed assets to their residual value over their estimated useful lives as follows: % Computer equipment 33 Office furniture and equipment 8-15 Leasehold improvements are depreciated by the straight-line method over the shorter of the term of the lease or the estimated useful life of the improvements. 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 Amounts due for future payments based on contractual agreements are accrued upon reaching the relevant milestones. NOTE 2 - SUMMARY OF MATERIAL ACCOUNTING POLICIES : 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, 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. NOTE 2 - SUMMARY OF MATERIAL ACCOUNTING POLICIES : 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. 1) Revenue from the sale of products The Company sells products mainly to wholesale distributors. Revenue is recognized at a point in time when control over the product is transferred to the customer (upon delivery), at the net selling price, which reflects reserves for variable consideration, including discounts and allowances. The Company estimates variable consideration and includes it in the transaction price using the most likely outcome method, and only to the extent it is highly probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The specific considerations the Company uses in estimating these amounts related to variable consideration are as follows: Trade discounts and distribution fees - The Company offers discounts to its customers, as an incentive for prompt payment. The Company records these discounts as a reduction of revenue in the period the related revenue from the sale of products is recognized. In addition, distribution fees are paid to certain distributors based on contractually determined rates from the gross consideration. As the fee paid to the customer is not for a distinct good or service, it is recognized as a reduction of revenue in the period the related revenue from the sale of products is recognized. Rebates and patient discount programs - The Company offers various rebate and patient discount programs, which result in discounted prescriptions to qualified patients. The Company estimates the allowance for these rebates and coupons based on historical and estimated utilization of the rebate and discount programs, at the time the revenues are recognized. These estimates are recognized as a reduction of revenue. 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. NOTE 2 - SUMMARY OF MATERIAL ACCOUNTING POLICIES : 2) Practical expedients and exemptions The Company expenses sales commissions when incurred since the amortization period of the asset that the Company otherwise would have recognized would have been for less than one year. These costs are recorded as selling and marketing expenses. 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). 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. NOTE 2 - SUMMARY OF MATERIAL ACCOUNTING POLICIES : 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. Recently issued accounting pronouncements: 1) Amendment to IAS 1, Presentation of Financial Statements: disclosure of accounting policies According to the amendment companies must provide disclosure of their material accounting policies rather than their significant accounting policies. Pursuant to the amendment, accounting policy information is material if, when considered with other information disclosed in the financial statements, it can be reasonably be expected to influence decisions that the users of the financial statements make on the basis of those financial statements. The amendment to IAS 1 also clarifies that accounting policy information is expected to be material if, without it, the users of the financial statements would be unable to understand other material information in the financial statements. The amendment also clarifies that immaterial accounting policy information need not be disclosed. The amendment, applicable for reporting periods beginning on or after January 1, 2023, was first applied by the Company in these annual financial statements. Should be Applied Retrospectively for Annual Periods Beginning on or After January 1, 2024: NOTE 2 - SUMMARY OF MATERIAL ACCOUNTING POLICIES : 2) 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 (e.g., the receipt of a waiver or a breach of covenant). The amendments also clarify what IAS 1 means when it refers to the ‘settlement’ of a liability. The amendments could 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. They must be applied retrospectively in accordance with the normal requirements in IAS 8, “Accounting Policies, Changes in Accounting Estimates and Errors.” The amendment should be applied retrospectively for annual periods beginning on or after January 1, 2024. Earlier application is permitted. The adoption of the amendment is expected to have an impact on the Company’s financial statements as, effective January 1, 2024, the Company’s warrant liabilities will be classified in current liabilities. |
CRITICAL ACCOUNTING ESTIMATES A
CRITICAL ACCOUNTING ESTIMATES AND JUDGMENTS | 12 Months Ended |
Dec. 31, 2023 | |
CRITICAL ACCOUNTING ESTIMATES AND JUDGMENTS | |
CRITICAL ACCOUNTING ESTIMATES AND JUDGMENTS | NOTE 3 - CRITICAL ACCOUNTING ESTIMATES AND JUDGMENTS: The preparation of financial statements requires management to make estimates which, by definition, will seldom equal the actual results and will affect the reported amounts in the Company’s consolidated financial statements and the accompanying notes. Some of the policies described in note 2 of the Company’s consolidated financial statements involve a high degree of judgment or complexity. The Company believes • • Recognition and measurement of allowance for rebates and patient discount programs 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. See also note 13. Impairment reviews of intangible R&D assets The Company reviews annually or when events or changes in circumstances indicate the carrying value of the R&D assets may not be recoverable. When and if necessary, an impairment loss is recognized for the amount by which the asset’s carrying amount exceeds its recoverable amount. The recoverable amount is determined using discounted cash flow calculations where the asset’s expected post-tax cash flows are risk-adjusted over their estimated remaining useful economic life. The risk-adjusted cash flows are discounted using the estimated Company’s post-tax weighted average cost of capital (“WACC”) which is 17.8%. NOTE 3 - CRITICAL ACCOUNTING ESTIMATES AND JUDGMENTS : The main estimates used in calculating the recoverable amount include: outcome of the therapeutic candidates R&D activities; probability of success in gaining regulatory approval, size of the potential market and the Company’s asset’s specific share in it and amount and timing of projected future cash flows. In the years presented in these financial statements, there were no impairments recorded for intangible R&D assets. |
FINANCIAL INSTRUMENTS AND FINAN
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT | 12 Months Ended |
Dec. 31, 2023 | |
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT | |
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT | NOTE 4 - FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT: Financial risk management: 1) Financial risk factors The Company’s 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 (i) 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. (ii) The Company’s main interest rate risk during the periods in these Financial Statements arose from long-term borrowing with interest on the outstanding loan computed as the 3-month USD LIBOR rate (hereinafter – the “LIBOR”), subject to a 1.75% floor rate, plus 8.2% fixed rate, which was decreased to 6.7%, starting April 1, 2021. The Company regularly monitored the LIBOR and its forward curve, however, due to the extinguishment of the Credit Agreement with HCRM, no longer faces material risks of interest rate fluctuation. (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). NOTE 4 - FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT : (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, 2023, and December 31, 2022. 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 As of December 31, 2023, 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. Contractual maturities of financial liabilities As of December 31, 2023 Less than 1 year 2-5 years More than 5 years Total contractual cash flows Carrying amount U.S. Dollars in Thousands Account payable 3,278 — — 3,278 3,278 Lease liabilities 766 475 — 1,241 1,173 Accrued expenses and other current liabilities 4,592 — — 4,592 4,592 Royalty obligation — 282 1,553 1,835 540 Total 8,636 757 1,553 10,946 9,583 Contractual maturities of financial liabilities As of December 31, 2022 Less than 1 year 2-5 years More than 5 years Total contractual cash flows Carrying amount U.S. Dollars in Thousands Accounts payable 4,230 4,230 4,230 Lease liabilities 1,723 4,079 5,723 11,525 7,475 Accrued expenses and other current liabilities 17,949 — — 17,949 17,949 Borrowing 115,216 — — 115,216 115,216 Payable in respect of intangible assets purchase 11,650 — — 11,650 11,157 Royalty obligation — 197 1,449 1,646 750 Total 150,768 4,276 7,172 162,216 156,777 NOTE 4 - FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT : 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, 2023, and December 31, 2022: Derivative financial instruments Year Ended December 31, 2022 2021 U.S. dollars in thousands Balance at beginning of the period 2,623 — Initial recognition of financial liability 10,932 16,375 Initial recognition of unrecognized day 1 loss — (330) Exercise of financial liability (18,383) Fair value adjustments recognized in profit or loss 5,569 (13,422) Balance at end of the period 741 2,623 See also notes 17(b) |
CASH AND CASH EQUIVALENTS
CASH AND CASH EQUIVALENTS | 12 Months Ended |
Dec. 31, 2023 | |
CASH AND CASH EQUIVALENTS. | |
CASH AND CASH EQUIVALENTS | NOTE 5 - CASH AND CASH EQUIVALENTS: December 31, 2023 2022 U.S. dollars in thousands Cash in bank 5,569 13,323 Short-term bank deposits — 6,645 5,569 19,968 The carrying amounts of the cash and cash equivalents approximate their fair values. |
PREPAID EXPENSES AND OTHER RECE
PREPAID EXPENSES AND OTHER RECEIVABLES | 12 Months Ended |
Dec. 31, 2023 | |
PREPAID EXPENSES AND OTHER RECEIVABLES | |
PREPAID EXPENSES AND OTHER RECEIVABLES | NOTE 6 - PREPAID EXPENSES AND OTHER RECEIVABLES: December 31, 2023 2022 U.S. dollars in thousands Advance to suppliers 1,310 1,033 Government institutions 694 831 Prepaid expenses and others 797 2,523 2,801 4,387 The fair value of other receivables which constitute of financial assets |
INVENTORY
INVENTORY | 12 Months Ended |
Dec. 31, 2023 | |
INVENTORY | |
INVENTORY | NOTE 7 - INVENTORY: December 31, 2023 2022 U.S. dollars in thousands Raw materials 828 1,797 Work in progress 233 2,385 Finished goods 3,328 6,827 4,389 11,009 During the years ended December 31, 20 2 The amounts recognized include write-downs of inventories to net realizable value amounted to $ 1.3 23 2 |
FIXED ASSETS
FIXED ASSETS | 12 Months Ended |
Dec. 31, 2023 | |
FIXED ASSETS | |
FIXED ASSETS | NOTE 8 - FIXED ASSETS: The composition of assets and accumulated depreciation are grouped by major classifications: Cost Accumulated depreciation Depreciated balance December 31 December 31 December 31 2023 2022 2023 2022 2023 2022 U.S. dollars in thousands Office furniture and equipment (including computers) 1,059 1,199 956 933 103 266 Leasehold improvements 379 379 289 143 90 236 1,438 1,578 1,245 1,076 193 502 |
LEASES
LEASES | 12 Months Ended |
Dec. 31, 2023 | |
LEASES | |
LEASES | NOTE 9 - LEASES: Amounts recognized in the consolidated statements of financial position: December 31, 2023 2022 U.S dollars in thousands Right-of-use assets: Properties 773 5,630 Vehicles 216 1,062 989 6,692 Lease liabilities: Current 718 1,032 Non-current 455 6,443 1,173 7,475 Additions to the right-of-use assets and lease liabilities during the years ended 2023 2022 In June 2023, the company terminated an operating lease agreement in the U.S that was signed in March 2022 resulting in the recognition of $0.7 million as a gain in the Company’s consolidated statement of comprehensive income (loss). The early termination, which took place as part of cost reduction measures, occurred due to a decrease in the number of employees, significantly reducing the Company's need for the office lease. Amounts recognized in the consolidated statements of comprehensive loss: Year Ended December 31, 2023 2022 Depreciation charge of right-of-use assets Properties 798 924 Vehicles 478 945 1,276 1,869 Interest expense 367 430 Foreign exchange differences 3 (140) Expenses relating to short-term leases and leases of low-value assets are immaterial. The total cash outflow for leases in 2023 and 2022 was $1.5 million and $2 million respectively. |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 12 Months Ended |
Dec. 31, 2023 | |
INTANGIBLE ASSETS | |
INTANGIBLE ASSETS | NOTE 10 - INTANGIBLE ASSETS: a. Year Ended December 31, 2023 2022 U.S. dollars in thousands R&D assets: Cost: Balance at beginning of year 5,757 5,757 Balance at end of year 5,757 5,757 Accumulated amortization: Balance at beginning of year (148) (116) Amortization charges (31) (32) Balance at end of year (179) (148) 5,578 5,609 Commercialization assets: Cost: Balance at beginning of year 89,373 89,373 Disposal during the year (77,585) — Balance at end of year 11,788 89,373 Accumulated impairments and amortization: Balance at beginning of year (29,356) (23,370) Amortization and impairment charges (514) (5,986) Disposal during the year 18,082 — Balance at end of year (11,788) (29,356) — 60,017 5,578 65,626 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. |
LIABILITY FOR EMPLOYEE RIGHTS U
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT | 12 Months Ended |
Dec. 31, 2023 | |
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT | |
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT | NOTE 11 - LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT: The amounts charged as an expense with respect to defined contribution plans in 2023, 2022, and 2021 were $206,000, $261,000, and $285,000, respectively. |
ACCRUED EXPENSES AND OTHER CURR
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | 12 Months Ended |
Dec. 31, 2023 | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | NOTE 12- ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES: December 31, 2023 2022 U.S. dollars in thousands Accrued expenses 3,765 16,168 Employees and related liabilities 727 1,667 Government institutions 100 114 4,592 17,949 |
ALLOWANCE FOR DEDUCTIONS FROM R
ALLOWANCE FOR DEDUCTIONS FROM REVENUES | 12 Months Ended |
Dec. 31, 2023 | |
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: Rebates and patient discount programs Product returns Total U.S. dollars in thousands As of January 1, 2023 46,636 1,234 47,870 Increases 21,225 859 22,084 Decreases (utilized) (60,498) (2,969) (63,467) Adjustments 724 3,443 4,167 As of December 31, 2023 8,087 2,567 10,654 (1) (0) — 0 Rebates and patient discount programs Product returns Total U.S. dollars in thousands As of January 1, 2022 29,742 969 30,711 Increases 123,878 2,547 126,425 Decreases (utilized) (108,531) (2,192) (110,723) Adjustments 1,547 (90) 1,457 As of December 31, 2022 46,636 1,234 47,870 Rebates and patient discount programs Product returns Total U.S. dollars in thousands As of January 1, 2021 16,380 1,963 18,343 Increases 94,640 851 95,491 Decreases (utilized) (80,633) (2,179) (82,812) Adjustments (645) 334 (311) As of December 31, 2021 29,742 969 30,711 |
BORROWING
BORROWING | 12 Months Ended |
Dec. 31, 2023 | |
BORROWING. | |
BORROWING | NOTE 14 – BORROWING: a. 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, RedHill Inc. reached a definitive 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. See also note 15(6). NOTE 14 – BORROWING : 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 Financial Position and the Statements of Cash Flows. Instead, these amounts are presented as restricted cash in the Statements of Financial Position and the movements in this restricted cash are presented as financing activities in the Statements of Cash Flows . b. Reconciliation of liabilities arising from financing activities: U.S. dollars in thousands Non-cash changes January 1, 2023 Proceeds from borrowings Principal and interest payments (includes credits) Addition during the year Decreases during the year Interest expense Foreign exchange movement December 31, 2023 Borrowing 115,216 — — — (115,216) — — — Payable in respect of intangible assets purchase 11,157 — (6,555) — (4,602) — — — Lease liabilities 7,475 — (1,529) 270 (5,413) 367 3 1,173 Non-cash changes January 1, 2022 Proceeds from borrowings Principal and interest payments Addition during the year Decreases during the year Interest expense Foreign exchange movement December 31, 2022 Borrowing 83,620 (7,507) — — 39,103 — 115,216 Payable in respect of intangible assets purchase 20,480 (11,123) — — 1,800 — 11,157 Lease liabilities 4,192 (2,010) 5,003 430 (140) 7,475 Non-cash changes January 1, 2021 Proceeds from borrowings Principal and interest payments Addition during the year Decreases during the year Interest expense Foreign exchange movement December 31, 2021 Borrowing 81,386 — (9,701) — — 11,935 — 83,620 Payable in respect of intangible assets purchase 24,746 — (8,500) — — 4,234 — 20,480 Lease liabilities 5,517 — (2,107) 385 — 355 42 4,192 |
COMMITMENTS
COMMITMENTS | 12 Months Ended |
Dec. 31, 2023 | |
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, 2023, the Company has paid the Australian company in total $1.5 million. NOTE 15 – COMMITMENTS : 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, 2023, 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 Following 4) Movantik ® acquisition: Effective April 1, 2020 (the (“Effective Date”), RedHill Inc. entered into an exclusive license agreement (the “License Agreement”) with AstraZeneca, granting RedHill Inc. exclusive, worldwide (excluding Europe, Canada) commercialization and development rights to Movantik® (naloxegol). An initial payment of $52.5 million was made to AstraZeneca on the Effective Date. Following an amendment on March 11, 2021, an additional $16 million was scheduled for gradual payments starting in March 2021 and ending in December 2022. As of December 31, 2022, the Company had an unsettled balance with respect to this payment which was settled early in 2023. RedHill Inc. also assumed responsibility for a 20% sales-based royalty, as well as sales-based potential milestone payments to Nektar Therapeutics, Movantik®’s originator. In addition, AstraZeneca transferred on the Effective Date to RedHill Inc. a co-commercialization agreement with Daiichi Sankyo, Inc. (“DSI”) for Movantik® in the U.S, See also note 15 (5) NOTE 15 – COMMITMENTS The total acquisition consideration, including upfront payment, discounted present value of the deferred payment amounted to approximately $65 million. The intangible asset was amortized on a straight-line basis over its useful life, which was re-estimated at approximately 12.5 The sales-based royalties were expensed as incurred and recognized under Cost of Revenues. 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 described in note 15(4) above, 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. took on all responsibilities and costs for commercializing Movantik® in the U.S, while decreasing to a mid-teen royalty rate on net sales of Movantik® in the U.S and committing to payments totaling $15.1 million, of which $10.1 million paid during 2022, and the remaining of $5 million were assumed by HCRM under the agreement described in notes 14 and 15(4). Additionally, in July 2020, as part of the new agreement, DSI received 7,085 ADSs of the Company. Movantik Transaction: 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. HCRM assumed substantially all post-closing liabilities, and RedHill Inc. retained substantially all pre-closing liabilities relating to Movantik®. As part of the parties' arrangement, and to ensure continuous patient care, RedHill Inc. also provided nine months of paid transition services. HCRM retains security interests in certain of the Company’s assets until substantially all pre-closing liabilities of Movantik® have been paid or other specific conditions are met. Following the agreement, the $16 million held as restricted cash under the Credit Agreement was deposited into an escrow account to pay pre-closing liabilities of Movantik®. 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). NOTE 15 – COMMITMENTS 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. 7) In October 2021, the Company entered into an exclusive license agreement (the “License Agreement”) with Gaelan Medical Trade LLC ("Gaelan") for Talicia® in the United Arab Emirates NOTE 15 – COMMITMENTS 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, following Kukbo's |
INCOME TAX
INCOME TAX | 12 Months Ended |
Dec. 31, 2023 | |
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%. NOTE 16 - INCOME TAX : b. U.S. subsidiary: The Company’s subsidiary is incorporated in the U.S. and is taxed under U.S. tax laws. As a general rule, inter-company transactions between the Israel-resident Company and its U.S-resident subsidiary are subject to the reporting provisions of the Income Tax Regulations, section 85-A, 2006 of the Israeli Tax Ordinance of the Israeli Tax Ordinance. c Carryforward losses : As of December 31, 2023, the Company had net operating loss (“NOLs”) carried forward of approximately $340 million. Under Israeli tax laws, carryforward tax losses have no expiration date. As of December 31, 2023, the U.S. subsidiary had a net operating loss carryforward of approximately $55 million, of which approximately $4 million expires in 2038, and approximately $51 million does not expire, but is limited to offset 80% of the net income in the year it is utilized. Under U.S. tax laws, for NOLs arising after December 31, 2017, the 2017 Act limits a taxpayer’s ability to utilize NOL carryforwards to 80% of taxable income. In addition, NOLs arising after 2017 can be carried forward indefinitely, but carryback is generally prohibited. NOLs generated in tax years beginning before January 1, 2018, will not be subject to the foregoing taxable income limitation and will continue to have a two-year carryback and twenty-year carryforward period. Furthermore, in accordance with Coronavirus Aid, Relief, and Economic Security Act (CARES Act) of 2020, losses from tax years beginning in 2018, 2019 or 2020 can be carried back 5 years. Deferred tax assets on losses for tax purposes carried forward to subsequent years are recognized if utilization of the related tax benefit against a future taxable income is expected. The Company has not created deferred taxes on its carryforward losses since their utilization is not expected in the foreseeable future. d Deductible temporary differences: The amount of cumulative deductible temporary differences, other than carryforward losses (as mentioned in c. above), for which deferred tax assets have not been recognized in the Statements of Financial Position as of December 31, 2023, and 2022, were $6 million and $14 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 201 7 |
SHARE CAPITAL
SHARE CAPITAL | 12 Months Ended |
Dec. 31, 2023 | |
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: Number of shares December 31, 2023 2022 In thousands Authorized ordinary shares 19,994,000 1,594,000 Authorized preferred shares (reserved) 6,000 6,000 Issued and paid ordinary shares 7,869,853 931,962 On March 23, 2023, the Company implemented a ratio change of the Company's ADSs to its non-traded ordinary shares from ratio of 1 ADS representing 10 ordinary shares to a new ratio of 1 ADS representing 400 ordinary shares. All data dominated in ADS were adjusted for this ratio change. On November 29, 2023, the annual general meeting of shareholders approved the increase of the authorized share capital of the Company to NIS 200,000,000 divided into (i) 19,994,000,000 registered Ordinary Shares of NIS 0.01 par value each, and (ii) 6,000,000 preferred shares of NIS 0.01 par value each. b. On April 3, 2023, the Company completed a registered direct offering to an existing shareholder with gross proceeds to the Company of approximately $6 million, before deducting offering expenses of approximately $0.7 million. The offering consisted of 1,500,000 ADSs (or ADS equivalents which consist of pre-funded warrants with an exercise price of $0.001 per pre-funded warrant) as well as granted (i) Series A unregistered private warrants to purchase up to 1,500,000 ADSs, which had an exercise price of $4.75 per ADS (subsequently reduced to $1.35 per ADS as described below), were exercisable immediately after the issuance date and had a term of 5 years and (ii) Series B unregistered private warrants to purchase up to 1,500,000 ADSs, which had an exercise price of $4.00 per ADS (subsequently reduced to $1.80 per ADS as described below), were exercisable immediately after the issuance date and had a term of 9 months. In addition, as part of the offering the Company has agreed to amend certain existing warrants to purchase up to 330,106 ADSs with an exercise price of $59.20 per ADS and a termination date of November 11, 2027. The amended warrants have a reduced exercise price of $4.75 per ADS and a termination date of 5 years following the closing of the offering. 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 90,000 ADSs with an exercise price of $5.00 per ADS, exercisable for 5 years. These warrants were classified to the Equity . c. On July 25, 2023, the Company completed a registered direct offering to existing shareholders of 1,301,923 ADSs (or ADS equivalent which consist of pre-funded warrants with an exercise price of $0.001 per pre-funded warrant), for gross proceeds of approximately $1.8 million, before deducting offering expenses of approximately $0.4 million. In connection with this offering, the Company also agreed with the investors in this offering on the following: NOTE 17 - SHARE CAPITAL : (i) To reduce the exercise price to $1.80 per ADS to the following existing warrants: (1) warrants originally issued on May 11, 2022 and subsequently amended on April 3, 2023, to purchase up to an aggregate of 330,106 ADSs at an exercise price of $4.75 per ADS, (2) warrants issued on December 6, 2022 to purchase up to an aggregate of 971,817 ADSs at an exercise price of $4.6305 per ADS, and (3) Series B Warrants issued on April 3, 2023 to purchase up to an aggregate of 1,500,000 ADSs at an exercise price of $4.00 per ADS. (ii) Series A Warrants issued on April 3, 2023, to purchase 1,500,000 ADSs, will be exercised at a reduced exercise price of $1.35 per ADS, for gross proceeds of $2 million. New unregistered private warrants to purchase up to 1,500,000 ADSs will be granted to the same investor. The new warrants have an exercise price of $1.80 per ADS, are exercisable 6 months after the issuance date and have a term of 5 years. 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 78,115 ADSs with an exercise price of $1.6875 per ADS, exercisable for 5 years (ii) to purchase up to 90,000 ADSs with an exercise price of $1.6875 per ADS, exercisable for 4.7 years. These warrants were classified to the Equity. d. On September 28, 2023, the Company entered into a warrant reprice and reload letter of certain existing warrants to purchase (i) up to 330,106 ADSs with an exercise price of $1.80 per ADS and a termination date of April 3, 2028, (ii) up to 971,817 ADSs with an exercise price of $1.80 per ADS and a termination date of December 6, 2027, (iii) up to 1,500,000 ADSs with an exercise price of $1.80 per ADS and a termination date of January 3, 2024, and (iv) up to 1,500,000 ADSs with an exercise price of $1.80 per ADS and a termination date of April 3, 2028, pursuant to which such investors agreed to exercise their existing warrants in full at a reduced exercise price of $0.47 per ADS for aggregate gross proceeds of approximately $2.0 million, before deducting offering expenses of approximately $0.2 million. In exchange, the exercising holders received new unregistered warrants to purchase up to an aggregate of 8,603,846 ADSs at an exercise price of $0.47 per ADS and with exercise terms ranging from eighteen months to five years . 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 the amount of $0.6 million, was included as a financial expense. See also note 17(e) regarding the exercise of the above warrants. As part of the offering, the Company has issued to the placement agent warrants to purchase up to 258,115 ADSs with an exercise price of $0.5875 per ADS, exercisable for 5 years. These warrants were classified to the Equity . e. Between November 27, 2023, and November 29, 2023, the warrants issued in September 2023 as described above were exercised for a total of approximately $4 million gross proceeds to the Company. NOTE 17 - SHARE CAPITAL : f. The fair value of the warrants that were issued to the investors was computed using the Black and Scholes option pricing model. The fair value of the outstanding warrants that were issued to the investors as of December 31, 2023, was based on the price of an ADS on December 31, 2023, and based on the following parameters: risk-free interest rate of 3.93% and an average standard deviation of 126.71% . g. During 2023, the Company issued 47,336 ADSs resulting from vested RSUs that had been issued to employees and consultants of the Company. h. During 2022, the Company sold 30,582 ADSs under the “at-the-market” equity offering program (“ATM program”) at an average price of $ 66.8 per ADS, for aggregate net proceeds of approximately $2 million, net of an immaterial amount of issuance expenses. The sales were under the Company's sales agreement with Cantor Fitzgerald & Co. upon the terms and subject to the conditions and limitations in the sales agreement, the Company may elect from time to time, to offer and sell its ADSs having aggregate gross sales proceeds of up to $100 million through the ATM program. i. In May 2022, the Company entered into a definitive agreement with a single investor, which entailed the issuance of 264,085 ADSs (or ADS equivalent which consist of pre-funded warrants with an exercise price of $0.001 per pre-funded warrant) and grant of unregistered private warrants to purchase up to 330,106 ADSs, for a total net consideration of $14.4 million. The warrants had an exercise price of $59.2 per ADS (as later amended as described above), were exercisable six months after the issuance date, and had a term of five and one-half years 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, $8.1 million was allocated to the warrants. The remainder of approximately $6.9 million was allocated to equity. Issuance expenses of approximately $0.6 million were allocated as following: $0.3 million allocated to the liability instruments and were recorded directly to the Consolidated Statements of Comprehensive Income (Loss) and $0.3 million allocated to the equity j. In December 2022, the Company completed an underwritten public offering with gross proceeds to the Company of approximately $8 million . The offering consisted of 800,000 ADSs (or ADS equivalent which consist of pre-funded warrants with an exercise price of $0.001 per pre-funded warrant) as well as granted warrants to purchase up to 800,000 ADSs. Issuance expenses of approximately $0.6 million were recorded directly to the Consolidated Statements of Comprehensive Income (Loss) . NOTE 17 - SHARE CAPITAL : The warrants had an exercise price of $10 per ADS, were exercisable immediately after the issuance date and had a term of 5 years . The warrants may be exercised either for cash or on a cashless basis. 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. After initial recognition, the unrecognized day 1 loss of the warrants is amortized over its contractual life. The fair value of the warrants as of December 31, 2022, was based on the price of an ADS on December 31, 2022, and based on the following parameters: risk-free interest rate of 3.99% and an average standard deviation of 81.71% . k. During 2022, the Company issued 12,163 ADSs resulting from vested RSUs that had been issued to employees and consultants of the Company . |
SHARE-BASED PAYMENTS
SHARE-BASED PAYMENTS | 12 Months Ended |
Dec. 31, 2023 | |
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, 2023, the Award Plan allows the Company to allocate up to 1,400,658,798 options to purchase ordinary shares and RSUs to employees, consultants, and directors and are reserved by the BoD for issuance under the Award Plan. The terms and conditions of the grants were determined by the BoD and are according to the Award Plan. a. O n July 1, 2023, The Board of Directors of the Company granted 187,500 RSUs to the employees and consultants of the Company. The RSUs will vest in 12 equal quarterly installments over a three year -period. The fair value for the RSUs grant on the date of the grant was $ 0.2 million. The fair value of the RSUs was determined based on the price of an ADS on the date the RSUs were granted. reversed expenses . b. The following is information on options granted in 2022: Number of options granted According to the Award Plan Exercise Fair value of of the Company (1) price for 1 options on date of Other than to Ads grant in U.S. dollars Date of BoD directors (1) $) in thousands (2) January 2022 125 56.4 7 March 2022 150 66.8 6 275 13 NOTE 18 - SHARE-BASED PAYMENTS : 1) The options will vest as follows: for directors, employees and consultants of the Company and the Company's subsidiary who had provided services exceeding one year as of the grant date, options will vest in 16 equal quarterly installments over a four-year period. For directors, employees and consultants of the Company and the Company's subsidiary who had not provided services exceeding one year as of the grant date, the options will vest as follows: 1 /4 of the options will vest one year following the grant date and the rest will vest over 12 equal quarterly installments. During the contractual term, the options will be exercisable, either in full or in part, from the vesting date until the end of 10 years from the date of grant . 2) The fair value of the options was computed using the binomial model and the underlying data used was mainly the following: price of the Company’s ADSs: $66.8 - $98 , expected volatility: 66.94% - 67.21% , risk-free interest rate: 1.73% - 1.78% and the expected term was derived based on the contractual term of the options, the expected exercise behavior and expected post-vesting forfeiture rates. c. The following is information on RSUs granted in 2022: Fair value of Number of RSUs granted RSUs on date of According to the Award Plan of the Company grant in U.S. dollars Date of BoD Other than to Directors To directors (4) Total in thousands (5) January 2022 (1) 48,013 3,500 51,513 5,712 March 2022 (1) 2,400 — 2,400 160 April 2022(1) 875 — 875 87 June 2022 (2) 50,463 4,125 54,588 1,878 July 2022 (2) 1,625 — 1,625 56 September 2022 (3) 9,257 1,276 10,533 352 November 2022 (3) 15,085 — 15,085 380 Total 127,718 8,901 136,619 8,625 1) 2) 3) 4) In addition, In June 2022 September 2022 NOTE 18 - SHARE-BASED PAYMENTS : 5) The fair value of the RSUs were determined based on the price of an ADS on the date the RSUs were granted. During 2022, approximately 68.2 thousand options and RSUs were forfeited, resulting in $4.5 million reversed expenses . d. Changes in the number of options in ADSs and weighted averages of exercise prices are as follows: Year Ended December 31, 2023 2022 Weighted Weighted average of average of Number of exercise Number of exercise options price ($) options price ($) Outstanding at beginning of year 131,484 255.60 170,537 260.00 Exercised — — — 283.20 Expired and forfeited (34,133) 262.43 (39,328) 272.80 Granted — — 275 80.80 Outstanding at end of year 97,351 252.98 131,484 255.60 Exercisable at end of year 86,368 249.14 98,762 249.20 e. Changes in the number of RSUs in ADSs during the period are as follows: Year Ended December 31, 2023 2022 Number of Number of RSUs RSUs Outstanding at beginning of year 91,144 — Exercised (66,460) (12,163) Expired and forfeited (34,160) (28,861) Granted 187,500 132,168 Outstanding at end of year 178,024 91,144 f. The following is information about the exercise price and remaining useful life of outstanding options at year-end: Year Ended December 31, 2023 2022 Number of Number of options Weighted options Weighted outstanding average of outstanding average of at end of Exercise price remaining at end of Exercise price remaining year range useful life year range useful life 97,351 $66.8-$436 5.2 131,484 $66.8-$624 5.2 g. Expenses recognized in profit or loss for the options and RSUs are as follows: Year Ended December 31, 2023 2022 2021 U.S. dollars in thousands 1,647 5,675 10,212 The remaining compensation expenses as of December 31, 2023, are $0.8 million and will be expensed in full by December 2026. |
NET REVENUES
NET REVENUES | 12 Months Ended |
Dec. 31, 2023 | |
NET REVENUES | |
NET REVENUES | NOTE 19 - NET REVENUES : Year Ended December 31, 2023 2022 2021 U.S dollars in thousands Licensing revenues (1) — 2,000 — Sales of products (2) 6,530 59,800 85,757 6,530 61,800 85,757 (1) related to the License Agreement with Gaelan for Talicia® in the United Arab Emirates, see note 15(7) above. (2) In 2023, the Company recognized contra-revenues of ( $2.6 ) million for Movantik®, primarily from returns, following its divestiture on February 1, 2023 (see note 15(6) above). In 2022 and 2021, net revenues for Movantik® were $52.1 million and $76.8 million, respectively. Correspondingly, net revenues from sales of other products (mainly Talicia®) in the U.S. were $9.1 million, $7.7 million, and $9 million in 2023, 2022 and 2021, respectively. |
RESEARCH AND DEVELOPMENT EXPENS
RESEARCH AND DEVELOPMENT EXPENSES | 12 Months Ended |
Dec. 31, 2023 | |
RESEARCH AND DEVELOPMENT EXPENSES. | |
RESEARCH AND DEVELOPMENT EXPENSES | NOTE 20 - RESEARCH AND DEVELOPMENT EXPENSES: Year Ended December 31, 2023 2022 2021 U.S. dollars in thousands Payroll and related expenses 390 661 839 Professional services 605 1,210 1,821 Share-based payments 138 1,151 1,910 Clinical and pre-clinical trials 1,891 3,872 23,905 Intellectual property development 222 180 349 Other 282 205 674 3,528 7,279 29,498 |
SELLING AND MARKETING EXPENSES
SELLING AND MARKETING EXPENSES | 12 Months Ended |
Dec. 31, 2023 | |
SELLING AND MARKETING EXPENSES | |
SELLING AND MARKETING EXPENSES | NOTE 21 - SELLING AND MARKETING EXPENSES: Year Ended December 31, 2023 2022 2021 U.S. dollars in thousands Payroll and related expenses 9,656 19,235 24,227 Share-based payments (51) 553 2,570 Professional services 3,056 6,596 17,441 Samples 54 836 1,008 Travel, Fleet, meals and related expenses 736 5,136 7,305 Office-related expenses 566 1,510 1,285 Other 739 1,576 1,787 14,756 35,442 55,623 |
GENERAL AND ADMINISTRATIVE EXPE
GENERAL AND ADMINISTRATIVE EXPENSES | 12 Months Ended |
Dec. 31, 2023 | |
GENERAL AND ADMINISTRATIVE EXPENSES | |
GENERAL AND ADMINISTRATIVE EXPENSES | NOTE 22 - GENERAL AND ADMINISTRATIVE EXPENSES: Year Ended December 31, 2023 2022 2021 U.S. dollars in thousands Payroll and related expenses 7,035 10,521 11,974 Share-based payments 1,560 3,971 5,732 Professional services and supply chain 5,391 10,787 11,040 Medical affairs 818 1,214 1,600 Office-related expenses 958 1,434 1,438 Other 457 659 581 16,219 28,586 32,365 |
FINANCIAL INCOME (EXPENSES), ne
FINANCIAL INCOME (EXPENSES), net | 12 Months Ended |
Dec. 31, 2023 | |
FINANCIAL INCOME (EXPENSES), net | |
FINANCIAL INCOME (EXPENSES), net | NOTE 23 - FINANCIAL INCOME (EXPENSES), net : Year Ended December 31, 2023 2022 2021 U.S dollars in thousands Financial income: Fair value gains on derivative financial instruments — 13,422 — Gains on extinguishment of debt obligations by transfer of the rights in Movantik 20,585 — — Other Income 210 — — Interest from bank deposits 94 140 51 20,889 13,562 51 Financial expenses: Interest for lease liabilities 367 430 395 Issuance cost in respect of warrants 2,034 958 — Loss from changes in exchange rates 115 40 28 Fair value loss on derivative financial instruments 5,569 — — Loss from modification of warrants terms as part of a new issuance, see notes 17(b) and 17(d) 1,459 — — Interest expenses related to borrowing and payable in respect of intangible assets purchase — 40,903 16,172 Other 61 56 65 9,605 42,387 16,660 Financial income (expenses), 11,284 (28,825) (16,609) |
SEGMENT INFORMATION
SEGMENT INFORMATION | 12 Months Ended |
Dec. 31, 2023 | |
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®. The following table presents segment profitability and a reconciliation to the consolidated net income (loss) and comprehensive income (loss) for the periods indicated: Year Ended December 31, 2023 2022 2021 U.S. dollars in thousands Commercial Operations Segment Adjusted EBITDA (20,173) (16,595) (15,527) Research And Development Adjusted EBITDA (8,165) (12,420) (37,247) Financial income (expenses), net 11,284 (28,825) (16,609) Share-based compensation to employees and service providers (1,647) (5,675) (10,212) Depreciation (1,445) (2,136) (1,914) Amortization and impairment of intangible assets (545) (6,018) (16,235) Gain from early termination of lease, net 543 — — Other income 44,064 — — Consolidated Comprehensive Income (Loss) 23,916 (71,669) (97,744) NOTE 24 - SEGMENT INFORMATION : b. Major customers The following table represent the percentages of total net revenues from the major customers: Year Ended December 31, 2023 2022 2021 Customer A 30% 32% 32% Customer B 28% 30% 31% Customer C 37% 33% 32% The Company’s revenues were entirely in the U.S. except licensing revenues, and 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, 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 SH
EARNINGS (LOSS) PER ORDINARY SHARE | 12 Months Ended |
Dec. 31, 2023 | |
EARNINGS (LOSS) PER ORDINARY SHARE | |
EARNINGS (LOSS) PER ORDINARY SHARE | NOTE 25 – EARNINGS (LOSS) PER ORDINARY SHARE: a. Basic The following is data taken into account in the computation of basic loss per share: Year Ended December 31, 2023 2022 2021 Earnings (Loss) (U.S. dollars in thousands) 23,916 (71,669) (97,744) Weighted average number of ordinary shares outstanding during the period (in thousands) 2,591,222 616,299 465,273 Basic earnings (loss) per share (U.S. dollars) 0.01 (0.12) (0.21) b. Diluted The Company had two categories of potentially dilutive ordinary shares: warrants issued to investors and options issued to employees and service providers. The effect of these options and warrants for all reporting years is anti-dilutive. The calculation of diluted earnings (loss) per share as of December 31, 2023, does not include 508,836,400 of ordinary shares underlying warrants, 38,940,330 of ordinary shares underlying options and 71,209,560 of ordinary shares underlying RSUs, because the effect would be anti-dilutive. |
RELATED PARTIES
RELATED PARTIES | 12 Months Ended |
Dec. 31, 2023 | |
RELATED PARTIES | |
RELATED PARTIES | NOTE 26 - RELATED PARTIES: a. Key management in 2023 includes members of the Board of Directors, including the Company’s Chief Commercial Officer and Chief Executive Officer: Year Ended December 31, 2023 2022 2021 U.S. dollars in thousands Key management compensation: Salaries and other short-term employee benefits 1,189 1,486 1,668 Post-employment benefits 56 64 91 Share-based payments 407 1,041 1,611 Other long-term benefits 35 44 54 b. Balances with related parties: December 31, 2023 2022 U.S. dollars in thousand Current liabilities - Credit balance in “accrued expenses and other current liabilities” 206 191 |
EVENTS SUBSEQUENT TO DECEMBER 3
EVENTS SUBSEQUENT TO DECEMBER 31, 2023 | 12 Months Ended |
Dec. 31, 2023 | |
EVENTS SUBSEQUENT TO DECEMBER 31, 2023 | |
EVENTS SUBSEQUENT TO DECEMBER 31, 2023 | NOTE 27 - EVENTS SUBSEQUENT TO DECEMBER 31, 2023: 1) On January 26, 2024, the Company issued in a registered direct offering, 10,000,000 ADSs at a purchase price of $0.80 per ADS and in a concurrent private offering, unregistered warrants to purchase 10,000,000 ADSs at an exercise price of $ 1.00 per ADS. The warrants that were issued to the investors may be exercised either in cash or on a cashless basis. The warrants are exercisable immediately and will expire five years from the date of issuance. As part of the offering, the Company issued to the placement agent warrants to purchase 600,000 ADSs at the same price and terms. The gross proceeds to the Company from the offering were $8 million, before deducting placement agent's fees and other offering expenses of approximately $0.9 million. 2) On March 21, 2024, the annual general meeting of shareholders approved the increase of the authorized share capital of the Company to NIS 400,000,000 divided into (i) 39,994,000,000 registered Ordinary Shares of NIS 0.01 par value each, and (ii) 6,000,000 preferred shares of NIS 0.01 par value each. 3) On April 3, 2024, the Company issued in a registered direct offering, 2,144,487 ADSs at a purchase price of $0.58289 per ADS and warrants to purchase 2,144,487 ADSs at an exercise price of $0.75 per ADS. The warrants that were issued to the investors may be exercised either in cash or on a cashless basis. The warrants are exercisable immediately and will expire five years from the date of issuance. The gross proceeds to the Company from the offering were $1.25 million, before deducting offering expenses of approximately $0.1 million. No placement agent was used in connection with the offering. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Basis for presentation of the financial statements | a. Basis for presentation of the financial statements The consolidated financial statements of the Company have been prepared in accordance with International Financial Reporting Standards (“IFRS”), as issued by the International Accounting Standards Board (“IASB”). The material accounting policies described below have been applied consistently in relation to all the periods presented, unless otherwise stated. The preparation of financial statements in conformity with IFRS requires the use of certain critical accounting estimates. It also requires management to exercise its judgment in applying the Company’s accounting policies. The areas involving a higher degree of judgment or complexity, or areas where assumptions and estimates are material to the financial statements, are disclosed in note 3. Actual results could differ significantly from those estimates and assumptions. |
Translation of foreign currency transactions and balances | b. Translation of foreign currency transactions and balances 1) Functional and presentation currency Items included in the consolidated financial statements are measured using the currency of the primary economic environment in which the Company and its subsidiary operate (the “Functional Currency”). The consolidated financial statements are presented in U.S. dollars (“$”), 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 | NOTE 2 - SUMMARY OF MATERIAL ACCOUNTING POLICIES : 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: % Computer equipment 33 Office furniture and equipment 8-15 Leasehold improvements are depreciated by the straight-line method over the shorter of the term of the lease or the estimated useful life of the improvements. |
Intangible assets | 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 Amounts due for future payments based on contractual agreements are accrued upon reaching the relevant milestones. NOTE 2 - SUMMARY OF MATERIAL ACCOUNTING POLICIES : 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, 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. NOTE 2 - SUMMARY OF MATERIAL ACCOUNTING POLICIES : 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. 1) Revenue from the sale of products The Company sells products mainly to wholesale distributors. Revenue is recognized at a point in time when control over the product is transferred to the customer (upon delivery), at the net selling price, which reflects reserves for variable consideration, including discounts and allowances. The Company estimates variable consideration and includes it in the transaction price using the most likely outcome method, and only to the extent it is highly probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The specific considerations the Company uses in estimating these amounts related to variable consideration are as follows: Trade discounts and distribution fees - The Company offers discounts to its customers, as an incentive for prompt payment. The Company records these discounts as a reduction of revenue in the period the related revenue from the sale of products is recognized. In addition, distribution fees are paid to certain distributors based on contractually determined rates from the gross consideration. As the fee paid to the customer is not for a distinct good or service, it is recognized as a reduction of revenue in the period the related revenue from the sale of products is recognized. Rebates and patient discount programs - The Company offers various rebate and patient discount programs, which result in discounted prescriptions to qualified patients. The Company estimates the allowance for these rebates and coupons based on historical and estimated utilization of the rebate and discount programs, at the time the revenues are recognized. These estimates are recognized as a reduction of revenue. 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. NOTE 2 - SUMMARY OF MATERIAL ACCOUNTING POLICIES : 2) Practical expedients and exemptions The Company expenses sales commissions when incurred since the amortization period of the asset that the Company otherwise would have recognized would have been for less than one year. These costs are recorded as selling and marketing expenses. 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). 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. |
Loss per ordinary 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. NOTE 2 - SUMMARY OF MATERIAL ACCOUNTING POLICIES : 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. |
Recently issued accounting pronouncements | m. Recently issued accounting pronouncements: 1) Amendment to IAS 1, Presentation of Financial Statements: disclosure of accounting policies According to the amendment companies must provide disclosure of their material accounting policies rather than their significant accounting policies. Pursuant to the amendment, accounting policy information is material if, when considered with other information disclosed in the financial statements, it can be reasonably be expected to influence decisions that the users of the financial statements make on the basis of those financial statements. The amendment to IAS 1 also clarifies that accounting policy information is expected to be material if, without it, the users of the financial statements would be unable to understand other material information in the financial statements. The amendment also clarifies that immaterial accounting policy information need not be disclosed. The amendment, applicable for reporting periods beginning on or after January 1, 2023, was first applied by the Company in these annual financial statements. Should be Applied Retrospectively for Annual Periods Beginning on or After January 1, 2024: NOTE 2 - SUMMARY OF MATERIAL ACCOUNTING POLICIES : 2) 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 (e.g., the receipt of a waiver or a breach of covenant). The amendments also clarify what IAS 1 means when it refers to the ‘settlement’ of a liability. The amendments could 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. They must be applied retrospectively in accordance with the normal requirements in IAS 8, “Accounting Policies, Changes in Accounting Estimates and Errors.” The amendment should be applied retrospectively for annual periods beginning on or after January 1, 2024. Earlier application is permitted. The adoption of the amendment is expected to have an impact on the Company’s financial statements as, effective January 1, 2024, the Company’s warrant liabilities will be classified in current liabilities. |
FINANCIAL INSTRUMENTS AND FIN_2
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT | |
Schedule of company's financial liabilities and estimated maturities | Contractual maturities of financial liabilities As of December 31, 2023 Less than 1 year 2-5 years More than 5 years Total contractual cash flows Carrying amount U.S. Dollars in Thousands Account payable 3,278 — — 3,278 3,278 Lease liabilities 766 475 — 1,241 1,173 Accrued expenses and other current liabilities 4,592 — — 4,592 4,592 Royalty obligation — 282 1,553 1,835 540 Total 8,636 757 1,553 10,946 9,583 Contractual maturities of financial liabilities As of December 31, 2022 Less than 1 year 2-5 years More than 5 years Total contractual cash flows Carrying amount U.S. Dollars in Thousands Accounts payable 4,230 4,230 4,230 Lease liabilities 1,723 4,079 5,723 11,525 7,475 Accrued expenses and other current liabilities 17,949 — — 17,949 17,949 Borrowing 115,216 — — 115,216 115,216 Payable in respect of intangible assets purchase 11,650 — — 11,650 11,157 Royalty obligation — 197 1,449 1,646 750 Total 150,768 4,276 7,172 162,216 156,777 |
Schedule of change in derivative financial instrument | Derivative financial instruments Year Ended December 31, 2022 2021 U.S. dollars in thousands Balance at beginning of the period 2,623 — Initial recognition of financial liability 10,932 16,375 Initial recognition of unrecognized day 1 loss — (330) Exercise of financial liability (18,383) Fair value adjustments recognized in profit or loss 5,569 (13,422) Balance at end of the period 741 2,623 |
CASH AND CASH EQUIVALENTS (Tabl
CASH AND CASH EQUIVALENTS (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
CASH AND CASH EQUIVALENTS. | |
Schedule of cash and cash equivalents | December 31, 2023 2022 U.S. dollars in thousands Cash in bank 5,569 13,323 Short-term bank deposits — 6,645 5,569 19,968 |
PREPAID EXPENSES AND OTHER RE_2
PREPAID EXPENSES AND OTHER RECEIVABLES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
PREPAID EXPENSES AND OTHER RECEIVABLES | |
Schedule of prepaid expenses and other receivables | December 31, 2023 2022 U.S. dollars in thousands Advance to suppliers 1,310 1,033 Government institutions 694 831 Prepaid expenses and others 797 2,523 2,801 4,387 |
INVENTORY (Tables)
INVENTORY (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
INVENTORY | |
Schedule of Inventory | December 31, 2023 2022 U.S. dollars in thousands Raw materials 828 1,797 Work in progress 233 2,385 Finished goods 3,328 6,827 4,389 11,009 |
FIXED ASSETS (Tables)
FIXED ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
FIXED ASSETS | |
Schedule of composition of assets and accumulated depreciation, grouped by major classifications | Cost Accumulated depreciation Depreciated balance December 31 December 31 December 31 2023 2022 2023 2022 2023 2022 U.S. dollars in thousands Office furniture and equipment (including computers) 1,059 1,199 956 933 103 266 Leasehold improvements 379 379 289 143 90 236 1,438 1,578 1,245 1,076 193 502 |
LEASES (Tables)
LEASES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
GENERAL | |
Schedule of amounts recognized for leases | December 31, 2023 2022 U.S dollars in thousands Right-of-use assets: Properties 773 5,630 Vehicles 216 1,062 989 6,692 Lease liabilities: Current 718 1,032 Non-current 455 6,443 1,173 7,475 Additions to the right-of-use assets and lease liabilities during the years ended 2023 2022 In June 2023, the company terminated an operating lease agreement in the U.S that was signed in March 2022 resulting in the recognition of $0.7 million as a gain in the Company’s consolidated statement of comprehensive income (loss). The early termination, which took place as part of cost reduction measures, occurred due to a decrease in the number of employees, significantly reducing the Company's need for the office lease. Amounts recognized in the consolidated statements of comprehensive loss: Year Ended December 31, 2023 2022 Depreciation charge of right-of-use assets Properties 798 924 Vehicles 478 945 1,276 1,869 Interest expense 367 430 Foreign exchange differences 3 (140) Expenses relating to short-term leases and leases of low-value assets are immaterial. The total cash outflow for leases in 2023 and 2022 was $1.5 million and $2 million respectively. |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
INTANGIBLE ASSETS | |
Schedule of intangible assets changes | Year Ended December 31, 2023 2022 U.S. dollars in thousands R&D assets: Cost: Balance at beginning of year 5,757 5,757 Balance at end of year 5,757 5,757 Accumulated amortization: Balance at beginning of year (148) (116) Amortization charges (31) (32) Balance at end of year (179) (148) 5,578 5,609 Commercialization assets: Cost: Balance at beginning of year 89,373 89,373 Disposal during the year (77,585) — Balance at end of year 11,788 89,373 Accumulated impairments and amortization: Balance at beginning of year (29,356) (23,370) Amortization and impairment charges (514) (5,986) Disposal during the year 18,082 — Balance at end of year (11,788) (29,356) — 60,017 5,578 65,626 |
ACCRUED EXPENSES AND OTHER CU_2
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | |
Schedule of accrued expenses and other current liabilities | December 31, 2023 2022 U.S. dollars in thousands Accrued expenses 3,765 16,168 Employees and related liabilities 727 1,667 Government institutions 100 114 4,592 17,949 |
ALLOWANCE FOR DEDUCTIONS FROM_2
ALLOWANCE FOR DEDUCTIONS FROM REVENUES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
ALLOWANCE FOR DEDUCTIONS FROM REVENUES | |
Schedule of movement of allowance for deductions from revenue | Rebates and patient discount programs Product returns Total U.S. dollars in thousands As of January 1, 2023 46,636 1,234 47,870 Increases 21,225 859 22,084 Decreases (utilized) (60,498) (2,969) (63,467) Adjustments 724 3,443 4,167 As of December 31, 2023 8,087 2,567 10,654 (1) (0) — 0 Rebates and patient discount programs Product returns Total U.S. dollars in thousands As of January 1, 2022 29,742 969 30,711 Increases 123,878 2,547 126,425 Decreases (utilized) (108,531) (2,192) (110,723) Adjustments 1,547 (90) 1,457 As of December 31, 2022 46,636 1,234 47,870 Rebates and patient discount programs Product returns Total U.S. dollars in thousands As of January 1, 2021 16,380 1,963 18,343 Increases 94,640 851 95,491 Decreases (utilized) (80,633) (2,179) (82,812) Adjustments (645) 334 (311) As of December 31, 2021 29,742 969 30,711 |
BORROWING (Tables)
BORROWING (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
BORROWING. | |
Schedule of reconciliation of liabilities arising from financing activities | U.S. dollars in thousands Non-cash changes January 1, 2023 Proceeds from borrowings Principal and interest payments (includes credits) Addition during the year Decreases during the year Interest expense Foreign exchange movement December 31, 2023 Borrowing 115,216 — — — (115,216) — — — Payable in respect of intangible assets purchase 11,157 — (6,555) — (4,602) — — — Lease liabilities 7,475 — (1,529) 270 (5,413) 367 3 1,173 Non-cash changes January 1, 2022 Proceeds from borrowings Principal and interest payments Addition during the year Decreases during the year Interest expense Foreign exchange movement December 31, 2022 Borrowing 83,620 (7,507) — — 39,103 — 115,216 Payable in respect of intangible assets purchase 20,480 (11,123) — — 1,800 — 11,157 Lease liabilities 4,192 (2,010) 5,003 430 (140) 7,475 Non-cash changes January 1, 2021 Proceeds from borrowings Principal and interest payments Addition during the year Decreases during the year Interest expense Foreign exchange movement December 31, 2021 Borrowing 81,386 — (9,701) — — 11,935 — 83,620 Payable in respect of intangible assets purchase 24,746 — (8,500) — — 4,234 — 20,480 Lease liabilities 5,517 — (2,107) 385 — 355 42 4,192 |
SHARE CAPITAL (Tables)
SHARE CAPITAL (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
SHARE CAPITAL | |
Schedule of composition of share capital | Number of shares December 31, 2023 2022 In thousands Authorized ordinary shares 19,994,000 1,594,000 Authorized preferred shares (reserved) 6,000 6,000 Issued and paid ordinary shares 7,869,853 931,962 |
SHARE-BASED PAYMENTS (Tables)
SHARE-BASED PAYMENTS (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
SHARE-BASED PAYMENTS | |
Schedule of information on options granted | b. The following is information on options granted in 2022: Number of options granted According to the Award Plan Exercise Fair value of of the Company (1) price for 1 options on date of Other than to Ads grant in U.S. dollars Date of BoD directors (1) $) in thousands (2) January 2022 125 56.4 7 March 2022 150 66.8 6 275 13 NOTE 18 - SHARE-BASED PAYMENTS : 1) The options will vest as follows: for directors, employees and consultants of the Company and the Company's subsidiary who had provided services exceeding one year as of the grant date, options will vest in 16 equal quarterly installments over a four-year period. For directors, employees and consultants of the Company and the Company's subsidiary who had not provided services exceeding one year as of the grant date, the options will vest as follows: 1 /4 of the options will vest one year following the grant date and the rest will vest over 12 equal quarterly installments. During the contractual term, the options will be exercisable, either in full or in part, from the vesting date until the end of 10 years from the date of grant . 2) The fair value of the options was computed using the binomial model and the underlying data used was mainly the following: price of the Company’s ADSs: $66.8 - $98 , expected volatility: 66.94% - 67.21% , risk-free interest rate: 1.73% - 1.78% and the expected term was derived based on the contractual term of the options, the expected exercise behavior and expected post-vesting forfeiture rates. c. The following is information on RSUs granted in 2022: Fair value of Number of RSUs granted RSUs on date of According to the Award Plan of the Company grant in U.S. dollars Date of BoD Other than to Directors To directors (4) Total in thousands (5) January 2022 (1) 48,013 3,500 51,513 5,712 March 2022 (1) 2,400 — 2,400 160 April 2022(1) 875 — 875 87 June 2022 (2) 50,463 4,125 54,588 1,878 July 2022 (2) 1,625 — 1,625 56 September 2022 (3) 9,257 1,276 10,533 352 November 2022 (3) 15,085 — 15,085 380 Total 127,718 8,901 136,619 8,625 1) 2) 3) 4) In addition, In June 2022 September 2022 NOTE 18 - SHARE-BASED PAYMENTS : 5) The fair value of the RSUs were determined based on the price of an ADS on the date the RSUs were granted. During 2022, approximately 68.2 thousand options and RSUs were forfeited, resulting in $4.5 million reversed expenses . |
Schedule of number of shares and weighted averages of exercise prices | Year Ended December 31, 2023 2022 Weighted Weighted average of average of Number of exercise Number of exercise options price ($) options price ($) Outstanding at beginning of year 131,484 255.60 170,537 260.00 Exercised — — — 283.20 Expired and forfeited (34,133) 262.43 (39,328) 272.80 Granted — — 275 80.80 Outstanding at end of year 97,351 252.98 131,484 255.60 Exercisable at end of year 86,368 249.14 98,762 249.20 |
Schedule of number of RSU,s | Year Ended December 31, 2023 2022 Number of Number of RSUs RSUs Outstanding at beginning of year 91,144 — Exercised (66,460) (12,163) Expired and forfeited (34,160) (28,861) Granted 187,500 132,168 Outstanding at end of year 178,024 91,144 |
Schedule of information about exercise price and remaining useful life of outstanding options | Year Ended December 31, 2023 2022 Number of Number of options Weighted options Weighted outstanding average of outstanding average of at end of Exercise price remaining at end of Exercise price remaining year range useful life year range useful life 97,351 $66.8-$436 5.2 131,484 $66.8-$624 5.2 |
Schedule of expenses recognized in profit or loss | Year Ended December 31, 2023 2022 2021 U.S. dollars in thousands 1,647 5,675 10,212 |
NET REVENUES (Tables)
NET REVENUES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
NET REVENUES | |
Schedule of net revenues | Year Ended December 31, 2023 2022 2021 U.S dollars in thousands Licensing revenues (1) — 2,000 — Sales of products (2) 6,530 59,800 85,757 6,530 61,800 85,757 |
RESEARCH AND DEVELOPMENT EXPE_2
RESEARCH AND DEVELOPMENT EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
RESEARCH AND DEVELOPMENT EXPENSES. | |
Schedule of research and development expenses | Year Ended December 31, 2023 2022 2021 U.S. dollars in thousands Payroll and related expenses 390 661 839 Professional services 605 1,210 1,821 Share-based payments 138 1,151 1,910 Clinical and pre-clinical trials 1,891 3,872 23,905 Intellectual property development 222 180 349 Other 282 205 674 3,528 7,279 29,498 |
SELLING AND MARKETING EXPENSES
SELLING AND MARKETING EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
SELLING AND MARKETING EXPENSES | |
Schedule of selling, marketing and business development expenses | Year Ended December 31, 2023 2022 2021 U.S. dollars in thousands Payroll and related expenses 9,656 19,235 24,227 Share-based payments (51) 553 2,570 Professional services 3,056 6,596 17,441 Samples 54 836 1,008 Travel, Fleet, meals and related expenses 736 5,136 7,305 Office-related expenses 566 1,510 1,285 Other 739 1,576 1,787 14,756 35,442 55,623 |
GENERAL AND ADMINISTRATIVE EX_2
GENERAL AND ADMINISTRATIVE EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
GENERAL AND ADMINISTRATIVE EXPENSES | |
Schedule of general and administrative expenses | Year Ended December 31, 2023 2022 2021 U.S. dollars in thousands Payroll and related expenses 7,035 10,521 11,974 Share-based payments 1,560 3,971 5,732 Professional services and supply chain 5,391 10,787 11,040 Medical affairs 818 1,214 1,600 Office-related expenses 958 1,434 1,438 Other 457 659 581 16,219 28,586 32,365 |
FINANCIAL INCOME (EXPENSES), _2
FINANCIAL INCOME (EXPENSES), net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
FINANCIAL INCOME (EXPENSES), net | |
Schedule of financial income (expenses), net | Year Ended December 31, 2023 2022 2021 U.S dollars in thousands Financial income: Fair value gains on derivative financial instruments — 13,422 — Gains on extinguishment of debt obligations by transfer of the rights in Movantik 20,585 — — Other Income 210 — — Interest from bank deposits 94 140 51 20,889 13,562 51 Financial expenses: Interest for lease liabilities 367 430 395 Issuance cost in respect of warrants 2,034 958 — Loss from changes in exchange rates 115 40 28 Fair value loss on derivative financial instruments 5,569 — — Loss from modification of warrants terms as part of a new issuance, see notes 17(b) and 17(d) 1,459 — — Interest expenses related to borrowing and payable in respect of intangible assets purchase — 40,903 16,172 Other 61 56 65 9,605 42,387 16,660 Financial income (expenses), 11,284 (28,825) (16,609) |
SEGMENT INFORMATION (Tables)
SEGMENT INFORMATION (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
SEGMENT INFORMATION | |
Schedule of segment profitability and reconciliation to consolidated net income (loss) and comprehensive income (loss) | Year Ended December 31, 2023 2022 2021 U.S. dollars in thousands Commercial Operations Segment Adjusted EBITDA (20,173) (16,595) (15,527) Research And Development Adjusted EBITDA (8,165) (12,420) (37,247) Financial income (expenses), net 11,284 (28,825) (16,609) Share-based compensation to employees and service providers (1,647) (5,675) (10,212) Depreciation (1,445) (2,136) (1,914) Amortization and impairment of intangible assets (545) (6,018) (16,235) Gain from early termination of lease, net 543 — — Other income 44,064 — — Consolidated Comprehensive Income (Loss) 23,916 (71,669) (97,744) |
Schedule of percentages of total net revenues from major customers | Year Ended December 31, 2023 2022 2021 Customer A 30% 32% 32% Customer B 28% 30% 31% Customer C 37% 33% 32% |
EARNINGS (LOSS) PER ORDINARY _2
EARNINGS (LOSS) PER ORDINARY SHARE (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
EARNINGS (LOSS) PER ORDINARY SHARE | |
Schedule of earnings (loss) per share | Year Ended December 31, 2023 2022 2021 Earnings (Loss) (U.S. dollars in thousands) 23,916 (71,669) (97,744) Weighted average number of ordinary shares outstanding during the period (in thousands) 2,591,222 616,299 465,273 Basic earnings (loss) per share (U.S. dollars) 0.01 (0.12) (0.21) |
RELATED PARTIES (Tables)
RELATED PARTIES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
RELATED PARTIES | |
Schedule of key management compensation: | Year Ended December 31, 2023 2022 2021 U.S. dollars in thousands Key management compensation: Salaries and other short-term employee benefits 1,189 1,486 1,668 Post-employment benefits 56 64 91 Share-based payments 407 1,041 1,611 Other long-term benefits 35 44 54 |
Schedule of balances with related parties | December 31, 2023 2022 U.S. dollars in thousand Current liabilities - Credit balance in “accrued expenses and other current liabilities” 206 191 |
GENERAL (Details)
GENERAL (Details) - shares | Mar. 23, 2023 | Mar. 22, 2023 |
General [Line Items] | ||
Number of Ordinary Shares Issued in Exchange of American Depository Receipts | 10 | |
ADS | ||
General [Line Items] | ||
Number of Ordinary Shares Issued in Exchange of American Depository Receipts | 400 | 10 |
New ADS Ratio [Member] | ||
General [Line Items] | ||
Number of Ordinary Shares Issued in Exchange of American Depository Receipts | 400 |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) | 12 Months Ended |
Dec. 31, 2023 | |
Computer equipment | |
Accounting Policies [Line Items] | |
Depreciation rate, property, plant and equipment | 33% |
Office furniture and equipment | Minimum | |
Accounting Policies [Line Items] | |
Depreciation rate, property, plant and equipment | 8% |
Office furniture and equipment | Maximum | |
Accounting Policies [Line Items] | |
Depreciation rate, property, plant and equipment | 15% |
CRITICAL ACCOUNTING ESTIMATES_2
CRITICAL ACCOUNTING ESTIMATES AND JUDGMENTS (Details) | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Movantik | |
Disclosure of significant unobservable inputs used in fair value measurement of assets [line items] | |
Impairment loss | $ 0 |
Useful life of assets (in years) | 12 years 6 months |
Weighted average cost of capital | |
Disclosure of significant unobservable inputs used in fair value measurement of assets [line items] | |
Significant unobservable input | 17.8 |
FINANCIAL INSTRUMENTS AND FIN_3
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT (Details) - shares | 12 Months Ended | |||
Mar. 23, 2023 | Dec. 31, 2023 | Apr. 01, 2021 | Mar. 31, 2021 | |
Financial instruments | ||||
Number of ordinary shares issued in exchange of ADS | 10 | |||
Maximum | ||||
Financial instruments | ||||
Maturity periods for cash balances in highly-rated bank deposits | 1 year | |||
Fixed rate | ||||
Financial instruments | ||||
Borrowings, interest rate | 6.70% | 8.20% | ||
3-month LIBOR floor rate | ||||
Financial instruments | ||||
Borrowings, interest rate | 1.75% | |||
Market risk [member] | ||||
Financial instruments | ||||
Percentage of currency stronger against the NIS | 5% |
FINANCIAL INSTRUMENTS AND FIN_4
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT - By contractual maturities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Financial instruments | ||
Financial liabilities | $ 10,946 | $ 162,216 |
Restricted cash | 147 | 150 |
Cost | ||
Financial instruments | ||
Financial liabilities | 9,583 | 156,777 |
Less than 1 year | ||
Financial instruments | ||
Financial liabilities | 8,636 | 150,768 |
2-5 years | ||
Financial instruments | ||
Financial liabilities | 757 | 4,276 |
More than five years | ||
Financial instruments | ||
Financial liabilities | 1,553 | 7,172 |
Accounts payable | ||
Financial instruments | ||
Financial liabilities | 3,278 | 4,230 |
Accounts payable | Cost | ||
Financial instruments | ||
Financial liabilities | 3,278 | 4,230 |
Accounts payable | Less than 1 year | ||
Financial instruments | ||
Financial liabilities | 3,278 | 4,230 |
Lease liabilities | ||
Financial instruments | ||
Financial liabilities | 1,241 | 11,525 |
Lease liabilities | Cost | ||
Financial instruments | ||
Financial liabilities | 1,173 | 7,475 |
Lease liabilities | Less than 1 year | ||
Financial instruments | ||
Financial liabilities | 766 | 1,723 |
Lease liabilities | 2-5 years | ||
Financial instruments | ||
Financial liabilities | 475 | 4,079 |
Lease liabilities | More than five years | ||
Financial instruments | ||
Financial liabilities | 5,723 | |
Accrued expenses and other current liabilities | ||
Financial instruments | ||
Financial liabilities | 4,592 | 17,949 |
Accrued expenses and other current liabilities | Cost | ||
Financial instruments | ||
Financial liabilities | 4,592 | 17,949 |
Accrued expenses and other current liabilities | Less than 1 year | ||
Financial instruments | ||
Financial liabilities | 4,592 | 17,949 |
Borrowing | ||
Financial instruments | ||
Financial liabilities | 115,216 | |
Borrowing | Cost | ||
Financial instruments | ||
Financial liabilities | 115,216 | |
Borrowing | Less than 1 year | ||
Financial instruments | ||
Financial liabilities | 115,216 | |
Payable in respect of intangible assets purchase | ||
Financial instruments | ||
Financial liabilities | 11,650 | |
Payable in respect of intangible assets purchase | Cost | ||
Financial instruments | ||
Financial liabilities | 11,157 | |
Payable in respect of intangible assets purchase | Less than 1 year | ||
Financial instruments | ||
Financial liabilities | 11,650 | |
Royalty obligation | ||
Financial instruments | ||
Financial liabilities | 1,835 | 1,646 |
Royalty obligation | Cost | ||
Financial instruments | ||
Financial liabilities | 540 | 750 |
Royalty obligation | 2-5 years | ||
Financial instruments | ||
Financial liabilities | 282 | 197 |
Royalty obligation | More than five years | ||
Financial instruments | ||
Financial liabilities | $ 1,553 | $ 1,449 |
FINANCIAL INSTRUMENTS AND FIN_5
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT - Changes in derivative liabilities (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT | ||
Balance at beginning of the period | $ 2,623 | |
Initial recognition of financial liability | 10,932 | $ 16,375 |
Initial recognition of unrecognized day 1 loss | (330) | |
Exercise of derivative into shares | (18,383) | |
Fair value adjustments recognized in profit or loss | 5,569 | (13,422) |
Balance at end of the period | $ 741 | $ 2,623 |
CASH AND CASH EQUIVALENTS (Deta
CASH AND CASH EQUIVALENTS (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
CASH AND CASH EQUIVALENTS. | ||||
Cash in bank | $ 5,569 | $ 13,323 | ||
Short-term bank deposits | 6,645 | |||
Cash and cash equivalents | $ 5,569 | $ 19,968 | $ 29,474 | $ 29,295 |
PREPAID EXPENSES AND OTHER RE_3
PREPAID EXPENSES AND OTHER RECEIVABLES (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
PREPAID EXPENSES AND OTHER RECEIVABLES | ||
Advance to suppliers | $ 1,310 | $ 1,033 |
Government institutions | 694 | 831 |
Prepaid expenses and others | 797 | 2,523 |
Total prepaid expenses and other receivables | $ 2,801 | $ 4,387 |
INVENTORY (Details)
INVENTORY (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
INVENTORY | |||
Raw materials | $ 828,000 | $ 1,797,000 | |
Work in progress | 233,000 | 2,385,000 | |
Finished goods | 3,328,000 | 6,827,000 | |
Total inventory | 4,389,000 | 11,009,000 | |
Inventories recognized as part of cost of revenues | 4,400,000 | 9,700,000 | $ 7,700,000 |
Inventories, at net realisable value | $ 1,300,000 | $ 2,400,000 | $ 300,000 |
FIXED ASSETS (Details)
FIXED ASSETS (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Fixed assets | ||
Accumulated depreciation | $ 1,245 | $ 1,076 |
Fixed assets | 193 | 502 |
Cost | ||
Fixed assets | ||
Fixed assets | 1,438 | 1,578 |
Office furniture and equipment (including computers) | ||
Fixed assets | ||
Accumulated depreciation | 956 | 933 |
Fixed assets | 103 | 266 |
Office furniture and equipment (including computers) | Cost | ||
Fixed assets | ||
Fixed assets | 1,059 | 1,199 |
Leasehold improvements | ||
Fixed assets | ||
Accumulated depreciation | 289 | 143 |
Fixed assets | 90 | 236 |
Leasehold improvements | Cost | ||
Fixed assets | ||
Fixed assets | $ 379 | $ 379 |
LEASES (Details)
LEASES (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Right-of-use assets: | ||
Right-of-use assets | $ 989,000 | $ 6,692,000 |
Lease liabilities: | ||
Current | 718,000 | 1,032,000 |
Non-current | 455,000 | 6,443,000 |
Lease liabilities | 1,173,000 | 7,475,000 |
Additions to right-of-use assets | 300,000 | 5,600,000 |
Additions to lease liabilities | 300,000 | 5,600,000 |
Decrease in lease liabilities | 5,400,000 | 600,000 |
Decrease in right of use asset | 4,700,000 | 500,000 |
Depreciation charge of right-of-use assets | 1,276,000 | 1,869,000 |
Interest expense | 367,000 | 430,000 |
Foreign exchange differences | 3,000 | (140,000) |
Cash outflow for leases | 1,500,000 | 2,000,000 |
Gain On Termination Of Operating Lease Agreement | 700,000 | |
Properties | ||
Right-of-use assets: | ||
Right-of-use assets | 773,000 | 5,630,000 |
Lease liabilities: | ||
Depreciation charge of right-of-use assets | 798,000 | 924,000 |
Vehicles | ||
Right-of-use assets: | ||
Right-of-use assets | 216,000 | 1,062,000 |
Lease liabilities: | ||
Depreciation charge of right-of-use assets | $ 478,000 | $ 945,000 |
INTANGIBLE ASSETS - Changes in
INTANGIBLE ASSETS - Changes in Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Reconciliation of changes in intangible assets | |||
Balance at beginning of year | $ 65,626 | ||
Amortization and impairment charges | (545) | $ (6,018) | $ (16,235) |
Write-Off due to the transfer of rights in Movantik | 18,082 | ||
Balance at end of year | 5,578 | 65,626 | |
R&D assets | |||
Reconciliation of changes in intangible assets | |||
Balance at beginning of year | 5,609 | ||
Balance at end of year | 5,578 | 5,609 | |
R&D assets | Cost | |||
Reconciliation of changes in intangible assets | |||
Balance at beginning of year | 5,757 | 5,757 | |
Balance at end of year | 5,757 | 5,757 | 5,757 |
R&D assets | Accumulated amortization | |||
Reconciliation of changes in intangible assets | |||
Balance at beginning of year | (148) | (116) | |
Amortization charges | (31) | (32) | |
Balance at end of year | (179) | (148) | (116) |
Commercialization assets | |||
Reconciliation of changes in intangible assets | |||
Balance at beginning of year | 60,017 | ||
Balance at end of year | 60,017 | ||
Commercialization assets | Cost | |||
Reconciliation of changes in intangible assets | |||
Balance at beginning of year | 89,373 | 89,373 | |
Write off during the year | 77,585 | ||
Balance at end of year | 11,788 | 89,373 | 89,373 |
Commercialization assets | Accumulated impairments and amortization | |||
Reconciliation of changes in intangible assets | |||
Balance at beginning of year | (29,356) | (23,370) | |
Amortization and impairment charges | (514) | (5,986) | |
Balance at end of year | $ (11,788) | $ (29,356) | $ (23,370) |
INTANGIBLE ASSETS - Narrative (
INTANGIBLE ASSETS - Narrative (Details) | 12 Months Ended |
Dec. 31, 2023 | |
Movantik | |
Reconciliation of changes in intangible assets | |
Useful life of assets (in years) | 12 years 6 months |
LIABILITY FOR EMPLOYEE RIGHTS_2
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT | |||
Defined contribution plans expense | $ 206,000 | $ 261,000 | $ 285,000 |
ACCRUED EXPENSES AND OTHER CU_3
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | ||
Accrued expenses | $ 3,765 | $ 16,168 |
Employees and related liabilities | 727 | 1,667 |
Government institutions | 100 | 114 |
Accrued expenses and other current liabilities | $ 4,592 | $ 17,949 |
ALLOWANCE FOR DEDUCTIONS FROM_3
ALLOWANCE FOR DEDUCTIONS FROM REVENUES (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Disclosure of other provisions [line items] | |||
Balance at beginning of the period | $ 47,870 | $ 30,711 | $ 18,343 |
Increases | 22,084 | 126,425 | 95,491 |
Decreases (utilized) | (63,467) | (110,723) | (82,812) |
Adjustments | 4,167 | 1,457 | (311) |
Balance at end of the period | 10,654 | 47,870 | 30,711 |
Rebates and patient discount programs | |||
Disclosure of other provisions [line items] | |||
Balance at beginning of the period | 46,636 | 29,742 | 16,380 |
Increases | 21,225 | 123,878 | 94,640 |
Decreases (utilized) | (60,498) | (108,531) | (80,633) |
Adjustments | 724 | 1,547 | (645) |
Balance at end of the period | 8,087 | 46,636 | 29,742 |
Product returns | |||
Disclosure of other provisions [line items] | |||
Balance at beginning of the period | 1,234 | 969 | 1,963 |
Increases | 859 | 2,547 | 851 |
Decreases (utilized) | (2,969) | (2,192) | (2,179) |
Adjustments | 3,443 | (90) | 334 |
Balance at end of the period | $ 2,567 | $ 1,234 | $ 969 |
BORROWING (Details)
BORROWING (Details) - USD ($) | Dec. 31, 2023 | Feb. 28, 2023 | Apr. 01, 2021 | Mar. 31, 2021 |
Movantik | ||||
Disclosure of detailed information about borrowings [line items] | ||||
Restricted cash transferred to collateral bank account | $ 800,000 | $ 16,000,000 | ||
3-month LIBOR floor rate | ||||
Disclosure of detailed information about borrowings [line items] | ||||
Interest rate (as a percent) | 1.75% | |||
Fixed rate | ||||
Disclosure of detailed information about borrowings [line items] | ||||
Interest rate (as a percent) | 6.70% | 8.20% |
BORROWING - Reconciliation of l
BORROWING - Reconciliation of liabilities arising from financing activities (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Borrowing | |||
Disclosure of reconciliation of liabilities arising from financing activities [line items] | |||
Beginning balance | $ 115,216 | $ 83,620 | $ 81,386 |
Principal and interest payments (includes credits) | (7,507) | (9,701) | |
Decreases during the year | (115,216) | ||
Interest expense | 39,103 | 11,935 | |
Ending balance | 115,216 | 83,620 | |
Payable in respect of intangible assets purchase | |||
Disclosure of reconciliation of liabilities arising from financing activities [line items] | |||
Beginning balance | 11,157 | 20,480 | 24,746 |
Principal and interest payments (includes credits) | (6,555) | (11,123) | (8,500) |
Decreases during the year | (4,602) | ||
Interest expense | 1,800 | 4,234 | |
Ending balance | 11,157 | 20,480 | |
Lease liabilities | |||
Disclosure of reconciliation of liabilities arising from financing activities [line items] | |||
Beginning balance | 7,475 | 4,192 | 5,517 |
Principal and interest payments (includes credits) | (1,529) | (2,010) | (2,107) |
Addition during the year | 270 | 5,003 | 385 |
Decreases during the year | (5,413) | ||
Interest expense | 367 | 430 | 355 |
Foreign exchange movement | 3 | (140) | 42 |
Ending balance | $ 1,173 | $ 7,475 | $ 4,192 |
COMMITMENTS - Agreements to Pur
COMMITMENTS - Agreements to Purchase Intellectual Property (Details) | Jun. 30, 2014 USD ($) | Aug. 11, 2010 USD ($) item | Dec. 31, 2023 USD ($) | Jul. 25, 2023 shares | Dec. 31, 2022 USD ($) shares | Dec. 31, 2018 USD ($) | Mar. 30, 2015 USD ($) |
Commitments | |||||||
Number of shares issued | shares | 1,301,923 | 12,163 | |||||
Australian Asset Purchase Agreement | |||||||
Commitments | |||||||
Number of therapeutic candidates | item | 3 | ||||||
Upfront initial payment per agreement | $ 500,000 | ||||||
Aggregate payments made | $ 1,500,000 | ||||||
Australian Asset Purchase Agreement | Minimum | |||||||
Commitments | |||||||
Percentage of revenues to be paid in the future | 7% | ||||||
Australian Asset Purchase Agreement | Maximum | |||||||
Commitments | |||||||
Percentage of revenues to be paid in the future | 20% | ||||||
German Publicly Traded Company Arrangement | |||||||
Commitments | |||||||
Upfront initial payment per agreement | $ 1,000,000 | ||||||
German Publicly Traded Company Arrangement | Maximum | |||||||
Commitments | |||||||
Royalties percentage | 30% | ||||||
U.S. Private Company Arrangement | |||||||
Commitments | |||||||
Milestones to be paid | $ 2,000,000 | ||||||
Non-current liability | 540,000 | $ 750,000 | $ 500,000 | ||||
Aggregate payments made | $ 3,000,000 | 1,500,000 | |||||
Revenue Milestone | U.S. Private Company Arrangement | Maximum | |||||||
Commitments | |||||||
Milestones to be paid | $ 2,000,000 |
COMMITMENTS - Movantik Acquisit
COMMITMENTS - Movantik Acquisition (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Apr. 01, 2020 | Dec. 31, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | |
Disclosure of detailed information about intangible assets [line items] | ||||
Intangible assets | $ 5,578,000 | $ 65,626,000 | ||
Movantik | ||||
Disclosure of detailed information about intangible assets [line items] | ||||
Percentage of royalty based on sales | 20% | |||
Intangible assets | $ 12,500,000 | |||
Present value of total consideration | $ 65,000,000 | |||
Useful life of assets (in years) | 12 years 6 months | |||
AstraZeneca AB | Movantik | ||||
Disclosure of detailed information about intangible assets [line items] | ||||
Payment for acquisition of rights | $ 52,500,000 | $ 16,000,000 |
COMMITMENTS - DSI Agreement (De
COMMITMENTS - DSI Agreement (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||||
Jul. 01, 2020 | May 31, 2022 | Dec. 31, 2023 | Jul. 25, 2023 | Feb. 28, 2023 | Dec. 31, 2022 | Jul. 31, 2020 | |
Disclosure of classes of share capital [line items] | |||||||
Number of shares issued | 1,301,923 | 12,163 | |||||
Intangible assets | $ 5,578,000 | $ 65,626,000 | |||||
ADS. | |||||||
Disclosure of classes of share capital [line items] | |||||||
Number of shares issued | 264,085 | 47,336 | |||||
Net proceeds from issuing shares | $ 14,400,000 | ||||||
Movantik | |||||||
Disclosure of classes of share capital [line items] | |||||||
Intangible assets | $ 12,500,000 | ||||||
Present value of future milestone payments | 10,500,000 | ||||||
Restricted cash transferred to collateral bank account | 800,000 | $ 16,000,000 | |||||
Fair value estimate | 95,000,000 | ||||||
Gains On Disposals Of Movantik | 35,500,000 | ||||||
Gains From The Debt Extinguishment. | 20,600,000 | ||||||
Movantik | DSI | |||||||
Disclosure of classes of share capital [line items] | |||||||
Royalty-bearing agreement, payments and settlements | $ 15,100,000 | ||||||
Movantik | DSI | ADS. | |||||||
Disclosure of classes of share capital [line items] | |||||||
Number of shares issued | 7,085 | ||||||
Financial component of issuance of stock | $ 2,000,000 | ||||||
July 2022 | Movantik | DSI | |||||||
Disclosure of classes of share capital [line items] | |||||||
Royalty-bearing agreement, payments and settlements | 10,100,000 | ||||||
February 2023 | Movantik | DSI | |||||||
Disclosure of classes of share capital [line items] | |||||||
Royalty-bearing agreement, payments and settlements | $ 5,000,000 |
COMMITMENTS - License Agreement
COMMITMENTS - License Agreements (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||||
Feb. 09, 2022 | Apr. 30, 2022 | Mar. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Disclosure of detailed information about intangible assets [line items] | ||||||
Licensing revenue | $ 2,000,000 | |||||
Net revenues | $ 6,530,000 | 61,800,000 | $ 85,757,000 | |||
Cost of revenues | $ 3,459,000 | 33,337,000 | $ 49,406,000 | |||
Kukbo Co. Ltd. | Subscription agreement | ||||||
Disclosure of detailed information about intangible assets [line items] | ||||||
Default amount | $ 5,000,000 | |||||
Kukbo Co. Ltd. | Exclusive license agreement | ||||||
Disclosure of detailed information about intangible assets [line items] | ||||||
Upfront payments received | $ 1,500,000 | |||||
Milestones to be paid | $ 5,600,000 | |||||
Default amount | $ 1,500,000 | |||||
Gaelan | Talicia | ||||||
Disclosure of detailed information about intangible assets [line items] | ||||||
Upfront payments received | $ 2,000,000 | |||||
Licensing revenue | $ 2,000,000 |
INCOME TAX (Details)
INCOME TAX (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax [Line Items] | ||
Deductible temporary differences | $ 6,000,000 | $ 14,000,000 |
Israel | ||
Income Tax [Line Items] | ||
Corporate tax rate | 23% | |
Net operating losses | $ 340,000,000 | |
U.S. | ||
Income Tax [Line Items] | ||
Corporate tax rate | 21% | |
Net operating losses | $ 55,000,000 | |
U.S. | Net operating losses expiring in 2037 | ||
Income Tax [Line Items] | ||
Net operating losses | 4,000,000 | |
U.S. | Net operating losses with no expiration | ||
Income Tax [Line Items] | ||
Net operating losses | $ 51,000,000 |
SHARE CAPITAL (Details)
SHARE CAPITAL (Details) | 1 Months Ended | 5 Months Ended | 12 Months Ended | ||||||||||||
Apr. 03, 2024 USD ($) | Sep. 28, 2023 USD ($) $ / shares shares | Jul. 25, 2023 USD ($) $ / shares shares | Apr. 03, 2023 USD ($) $ / shares shares | Mar. 23, 2023 shares | Mar. 22, 2023 shares | Dec. 31, 2022 USD ($) $ / shares shares | May 31, 2022 USD ($) $ / shares shares | Nov. 29, 2023 USD ($) $ / shares shares | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) | Mar. 21, 2024 $ / shares shares | Jan. 26, 2024 shares | Dec. 31, 2023 ₪ / shares shares | |
Disclosure of classes of share capital [line items] | |||||||||||||||
Proceeds from issuance | $ | $ 1,250,000 | $ 13,959,000 | $ 23,806,000 | $ 78,536,000 | |||||||||||
Offering expenses | $ | $ 100,000 | ||||||||||||||
Authorized ordinary shares | 200,000,000 | 400,000,000 | |||||||||||||
Number of Ordinary Shares Issued in Exchange of American Depository Receipts | 10 | ||||||||||||||
Number of shares issued | 1,301,923 | 12,163 | 12,163 | ||||||||||||
Financial expense | $ | 9,605,000 | $ 42,387,000 | 16,660,000 | ||||||||||||
Exercise price of warrants | $ / shares | $ 59.20 | ||||||||||||||
Proceeds from exercise of options | $ | $ 4,006,000 | ||||||||||||||
Share issuance expenses | $ | $ 600,000 | ||||||||||||||
Warrant issuance expense | $ | $ 600,000 | ||||||||||||||
Major ordinary share transactions | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 600,000 | ||||||||||||||
Pre-funded warrants | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Exercise price of warrants | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||||||
Series A unregistered private warrants | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 1,500,000 | ||||||||||||||
Exercise price of warrants | $ / shares | $ 1.80 | ||||||||||||||
Placement agent warrants | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 90,000 | ||||||||||||||
Warrants, exercisable term | 5 years | ||||||||||||||
Exercise price of warrants | $ / shares | $ 5 | ||||||||||||||
ADS | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Number of shares issued | 264,085 | 47,336 | |||||||||||||
Proceeds from issuance of shares | $ | $ 14,400,000 | ||||||||||||||
ADS | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Number of Ordinary Shares Issued in Exchange of American Depository Receipts | 400 | 10 | |||||||||||||
ADS | Series A unregistered private warrants | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 1,500,000 | ||||||||||||||
Exercise price of warrants | $ / shares | $ 1.35 | ||||||||||||||
Proceeds from issuance of shares | $ | $ 2,000,000 | ||||||||||||||
At-the-market equity offering program | ADS | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Number of shares issued | 30,582 | 30,582 | |||||||||||||
Proceeds from issuance of shares | $ | $ 2,000,000 | ||||||||||||||
Average share price | $ / shares | $ 66.8 | ||||||||||||||
At-the-market equity offering program | ADS | Maximum | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Proceeds from issuance of shares, gross | $ | $ 100,000,000 | ||||||||||||||
Underwritten public offering | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 971,817 | 971,817 | |||||||||||||
Exercise price of warrants | $ / shares | $ 1.80 | $ 4.6305 | |||||||||||||
Registered Direct Offering | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Proceeds from issuance | $ | $ 2,000,000 | $ 1,800,000 | 6,000,000 | ||||||||||||
Offering expenses | $ | $ 200,000 | $ 400,000 | $ 700,000 | ||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 330,106 | ||||||||||||||
Exercise price of warrants | $ / shares | $ 0.47 | $ 1.80 | |||||||||||||
Registered Direct Offering | Pre-funded warrants | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Exercise price of warrants | $ / shares | $ 0.001 | $ 0.001 | |||||||||||||
Registered Direct Offering | Unregistered Private Warrants | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 330,106 | 330,106 | |||||||||||||
Warrants term | 5 years | ||||||||||||||
Exercise price of warrants | $ / shares | $ 1.80 | $ 4.75 | |||||||||||||
Registered Direct Offering | Series A unregistered private warrants | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 1,500,000 | 1,500,000 | |||||||||||||
Warrants term | 5 years | ||||||||||||||
Exercise price of warrants | $ / shares | $ 1.80 | 1.35 | $ 4.75 | ||||||||||||
Registered Direct Offering | Series B unregistered private warrants | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 1,500,000 | 1,500,000 | |||||||||||||
Exercise price of warrants | $ / shares | $ 1.80 | $ 1.80 | $ 4 | ||||||||||||
Registered Direct Offering | New Unregistered Warrants | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 8,603,846 | ||||||||||||||
Warrants, exercisable term | 18 months | ||||||||||||||
Warrants term | 5 years | ||||||||||||||
Exercise price of warrants | $ / shares | $ 0.47 | ||||||||||||||
Registered Direct Offering | First portion of placement agent warrants | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 78,115 | ||||||||||||||
Warrants, exercisable term | 5 years | ||||||||||||||
Registered Direct Offering | Second portion of placement agent warrants | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Number of warrants to purchase shares | 90,000 | ||||||||||||||
Warrants term | 4 years 8 months 12 days | ||||||||||||||
Exercise price of warrants | $ / shares | $ 1.6875 | ||||||||||||||
Registered Direct Offering | Placement agent warrants | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 258,115 | ||||||||||||||
Warrants term | 5 years | ||||||||||||||
Exercise price of warrants | $ / shares | $ 0.5875 | ||||||||||||||
Proceeds from warrant exercises | $ | $ 4,000,000 | ||||||||||||||
Registered Direct Offering | ADS | First portion of placement agent warrants | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Exercise price of warrants | $ / shares | $ 1.6875 | ||||||||||||||
Registered Direct Offering | ADS | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Number of shares issued | 1,500,000 | ||||||||||||||
Ordinary shares. | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Par value per share | (per share) | $ 0.01 | $ 0.01 | ₪ 0.01 | ||||||||||||
Authorized ordinary shares | 1,594,000,000 | 19,994,000,000 | 1,594,000,000 | 39,994,000,000 | 19,994,000,000 | ||||||||||
Issued and paid ordinary shares | 931,962,000 | 931,962,000 | 7,869,853,000 | ||||||||||||
Ordinary shares. | ADS | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Number of shares issued | 800,000 | 800,000 | |||||||||||||
Proceeds from issuance of shares, gross | $ | $ 8,000,000 | ||||||||||||||
Equity component | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Share issuance expenses | $ | 300,000 | ||||||||||||||
Gross consideration | $ | 6,900,000 | ||||||||||||||
Preferred shares | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Par value per share | $ / shares | $ 0.01 | $ 0.01 | |||||||||||||
Authorized ordinary shares | 6,000,000 | 6,000,000 | |||||||||||||
Authorized preferred shares (reserved) | 6,000,000 | 6,000,000 | 6,000,000 | ||||||||||||
Warrants | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Financial expense | $ | $ 600,000 | $ 900,000 | |||||||||||||
Share issuance expenses | $ | 300,000 | ||||||||||||||
Gross consideration | $ | $ 8,100,000 | ||||||||||||||
Warrants | ADS | |||||||||||||||
Disclosure of classes of share capital [line items] | |||||||||||||||
Number of warrants to purchase shares | 800,000 | 800,000 | |||||||||||||
Class of warrant or right, number of securities called by warrants or rights | 10 | 59.2 | 10 | ||||||||||||
Warrants issued | 330,106 | ||||||||||||||
Warrants, exercisable term | 5 years | 6 months | |||||||||||||
Warrants term | 5 years 6 months | ||||||||||||||
Risk-free interest rate | 3.93% | 3.99% | |||||||||||||
Average standard deviation | 126.71% | 81.71% |
SHARE-BASED PAYMENTS (Details)
SHARE-BASED PAYMENTS (Details) | 1 Months Ended | 12 Months Ended | ||||
Jul. 01, 2023 | Sep. 30, 2022 USD ($) shares | Jun. 30, 2022 USD ($) shares | May 31, 2022 USD ($) shares | Dec. 31, 2023 USD ($) EquityInstruments shares Option installment | Dec. 31, 2022 USD ($) Option EquityInstruments installment $ / shares | |
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | Option | 275 | |||||
Exercise price for 1 ADS ($) | $ / shares | $ 80.80 | |||||
Number of RSUs granted | EquityInstruments | 187,500 | 132,168 | ||||
Number of options cancelled | Option | 34,133 | 39,328 | ||||
Each option exercisable into number of ordinary shares, ratio | Option | 86,368 | 98,762 | ||||
Stock Options | 2022 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Fair value on date of grant | $ 13,000 | |||||
Option term | 10 years | |||||
Stock Options | 2022 | Minimum | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Price of the Company's ordinary shares | $ / shares | $ 66.8 | |||||
Expected volatility | 66.94% | |||||
Risk free interest rate | 1.73% | |||||
Stock Options | 2022 | Maximum | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Price of the Company's ordinary shares | $ / shares | $ 98 | |||||
Expected volatility | 67.21% | |||||
Risk free interest rate | 1.78% | |||||
Stock Options | 2022 | Vesting, services exceeding one year | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of equal quarterly vesting installments | installment | 16 | |||||
Vesting period | 4 years | |||||
Stock Options | 2022 | Vesting, services exceeding one year | Minimum | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Service period | 1 year | |||||
Stock Options | 2022 | Vesting, services not exceeding one year | Maximum | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Service period | 1 year | |||||
Stock Options | 2022 | Vesting, one year following grant | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Vesting period | 1 year | |||||
Vesting percentage | 0.25% | |||||
Stock Options | 2022 | Vesting, two years following grant | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of equal quarterly vesting installments | installment | 12 | |||||
Stock Options | January 2022 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Exercise price for 1 ADS ($) | $ / shares | $ 56.4 | |||||
Fair value on date of grant | $ 7,000 | |||||
Stock Options | March 2022 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Exercise price for 1 ADS ($) | $ / shares | $ 66.8 | |||||
Fair value on date of grant | $ 6,000 | |||||
RSUs | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of RSUs granted | shares | 187,500 | |||||
Fair value on date of grant | $ 100,000 | $ 100,000 | $ 200,000 | |||
Number of equal quarterly vesting installments | installment | 12 | |||||
Vesting period | 3 years | |||||
Shares forfeited | 68,000 | |||||
Shares forfeited, reversed expenses | $ 1,600,000 | |||||
Shares approved for grant | shares | 5,401 | 5,401 | ||||
RSUs | 2022 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of RSUs granted | 136,619 | |||||
Fair value on date of grant | $ 100,000 | $ 8,625,000 | ||||
Shares approved for grant | shares | 3,500 | |||||
RSUs | 2022 | Vesting, one year following grant | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Vesting period | 1 year | |||||
Vesting percentage | 50% | |||||
RSUs | 2022 | Vesting, two years following grant | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Vesting period | 2 years | |||||
Vesting percentage | 50% | |||||
RSUs | 2022 | Vesting over three year period | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of equal quarterly vesting installments | installment | 12 | |||||
Vesting period | 3 years | |||||
RSUs | 2022 | Vesting over two year period | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of equal quarterly vesting installments | installment | 8 | |||||
Vesting period | 2 years | |||||
RSUs | January 2022 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of RSUs granted | 51,513 | |||||
Fair value on date of grant | $ 5,712,000 | |||||
RSUs | March 2022 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of RSUs granted | 2,400 | |||||
Fair value on date of grant | $ 160,000 | |||||
RSUs | April 2022 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of RSUs granted | 875 | |||||
Fair value on date of grant | $ 87,000 | |||||
RSUs | June 2022 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of RSUs granted | 54,588 | |||||
Fair value on date of grant | $ 1,878,000 | |||||
RSUs | July 2022 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of RSUs granted | 1,625 | |||||
Fair value on date of grant | $ 56,000 | |||||
RSUs | September 2022 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of RSUs granted | 10,533 | |||||
Fair value on date of grant | $ 352,000 | |||||
RSUs | November 2022 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of RSUs granted | 15,085 | |||||
Fair value on date of grant | $ 380,000 | |||||
Stock Options and RSUs | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Shares forfeited | 68,200 | |||||
Shares forfeited, reversed expenses | $ 4,500,000 | |||||
Shares approved for grant | shares | 1,400,658,798 | |||||
According to the Award Plan of the Company | 2022 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of RSUs granted | 127,718 | |||||
According to the Award Plan of the Company | January 2022 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of RSUs granted | 48,013 | |||||
According to the Award Plan of the Company | March 2022 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of RSUs granted | 2,400 | |||||
According to the Award Plan of the Company | April 2022 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of RSUs granted | 875 | |||||
According to the Award Plan of the Company | June 2022 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of RSUs granted | 50,463 | |||||
According to the Award Plan of the Company | July 2022 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of RSUs granted | 1,625 | |||||
According to the Award Plan of the Company | September 2022 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of RSUs granted | 9,257 | |||||
According to the Award Plan of the Company | November 2022 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of RSUs granted | 15,085 | |||||
According to the Award Plan of the Company | Stock Options | 2022 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 275 | |||||
According to the Award Plan of the Company | Stock Options | January 2022 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 125 | |||||
According to the Award Plan of the Company | Stock Options | March 2022 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of options granted | 150 | |||||
To directors | 2022 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of RSUs granted | 8,901 | |||||
To directors | January 2022 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of RSUs granted | 3,500 | |||||
To directors | June 2022 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of RSUs granted | 4,125 | |||||
To directors | September 2022 | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Number of RSUs granted | 1,276 |
SHARE-BASED PAYMENTS - Number o
SHARE-BASED PAYMENTS - Number of Options and Weighted Averages of Exercise Prices (Details) | 12 Months Ended | |
Dec. 31, 2023 Option $ / shares | Dec. 31, 2022 Option $ / shares | |
SHARE-BASED PAYMENTS | ||
Number of options, outstanding at beginning of year | Option | 131,484 | 170,537 |
Number of options, expired and forfeited | Option | (34,133) | (39,328) |
Number of options, granted | Option | 275 | |
Number of options, outstanding at end of year | Option | 97,351 | 131,484 |
Number of options, exercisable at end of year | Option | 86,368 | 98,762 |
Weighted average of exercise price, outstanding at beginning of year | $ 255.60 | $ 260 |
Weighted average of exercise price, exercised | 283.20 | |
Weighted average of exercise price, expired and forfeited | 262.43 | 272.80 |
Weighted average of exercise price, granted | 80.80 | |
Weighted average of exercise price, outstanding at end of year | 252.98 | 255.60 |
Weighted average of exercise price, exercisable at end of year | $ 249.14 | $ 249.20 |
SHARE-BASED PAYMENTS - Number_2
SHARE-BASED PAYMENTS - Number of RSUs (Details) - EquityInstruments | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
SHARE-BASED PAYMENTS | ||
Number of RSUs, Outstanding at beginning of year | 91,144 | |
Number of RSUs, Exercised | (66,460) | (12,163) |
Number of RSUs, Expired and forfeited | (34,160) | (28,861) |
Number of RSUs, Granted | 187,500 | 132,168 |
Number of RSUs, Outstanding at end of year | 178,024 | 91,144 |
SHARE-BASED PAYMENTS - Informat
SHARE-BASED PAYMENTS - Information About Exercise Price and Remaining Useful Life of Outstanding Options (Details) | 12 Months Ended | ||
Dec. 31, 2023 Option $ / shares | Dec. 31, 2022 Option $ / shares | Dec. 31, 2021 Option | |
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items] | |||
Number of options outstanding at end of Year | Option | 97,351 | 131,484 | 170,537 |
Weighted average of remaining useful life | 5 years 2 months 12 days | 5 years 2 months 12 days | |
Minimum | |||
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items] | |||
Exercise price range | $ 66.8 | $ 66.8 | |
Maximum | |||
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items] | |||
Exercise price range | $ 436 | $ 624 |
SHARE-BASED PAYMENTS - Expenses
SHARE-BASED PAYMENTS - Expenses Recognized in Profit or Loss (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
SHARE-BASED PAYMENTS | |||
Expenses recognized in profit or loss | $ 1,647 | $ 5,675 | $ 10,212 |
Unrecognized compensation expenses | $ 800 |
NET REVENUES (Details)
NET REVENUES (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Revenues | |||
Licensing revenues | $ 2,000,000 | ||
Movantik revenues | 52,100,000 | $ 76,800,000 | |
Sales of products | $ 6,530,000 | 59,800,000 | 85,757,000 |
Total Net Revenues | 6,530,000 | 61,800,000 | 85,757,000 |
Contra Revenue For Movantik | 2,600,000 | ||
Net Revenues From Other Products | $ 9,100,000 | $ 7,700,000 | $ 9,000,000 |
RESEARCH AND DEVELOPMENT EXPE_3
RESEARCH AND DEVELOPMENT EXPENSES (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Research And Development Expenses Net [Line Items] | |||
Research and development expenses | $ 3,528 | $ 7,279 | $ 29,498 |
Payroll and related expenses | |||
Research And Development Expenses Net [Line Items] | |||
Research and development expenses, gross | 390 | 661 | 839 |
Professional services | |||
Research And Development Expenses Net [Line Items] | |||
Research and development expenses, gross | 605 | 1,210 | 1,821 |
Share-based payments | |||
Research And Development Expenses Net [Line Items] | |||
Research and development expenses, gross | 138 | 1,151 | 1,910 |
Clinical and pre-clinical trials | |||
Research And Development Expenses Net [Line Items] | |||
Research and development expenses, gross | 1,891 | 3,872 | 23,905 |
Intellectual property development | |||
Research And Development Expenses Net [Line Items] | |||
Research and development expenses, gross | 222 | 180 | 349 |
Other | |||
Research And Development Expenses Net [Line Items] | |||
Research and development expenses, gross | $ 282 | $ 205 | $ 674 |
SELLING AND MARKETING EXPENSE_2
SELLING AND MARKETING EXPENSES (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Selling Marketing And Business Development Expenses [Line Items] | |||
Selling, and marketing expenses | $ 14,756 | $ 35,442 | $ 55,623 |
Payroll and related expenses | |||
Selling Marketing And Business Development Expenses [Line Items] | |||
Selling, and marketing expenses | 9,656 | 19,235 | 24,227 |
Share-based payments | |||
Selling Marketing And Business Development Expenses [Line Items] | |||
Selling And Marketing Expenses Share Based Payments | (51) | 553 | 2,570 |
Professional services | |||
Selling Marketing And Business Development Expenses [Line Items] | |||
Selling, and marketing expenses | 3,056 | 6,596 | 17,441 |
Samples | |||
Selling Marketing And Business Development Expenses [Line Items] | |||
Selling, and marketing expenses | 54 | 836 | 1,008 |
Travel, Fleet, meals and related expenses | |||
Selling Marketing And Business Development Expenses [Line Items] | |||
Selling, and marketing expenses | 736 | 5,136 | 7,305 |
Office-related expenses | |||
Selling Marketing And Business Development Expenses [Line Items] | |||
Selling, and marketing expenses | 566 | 1,510 | 1,285 |
Other | |||
Selling Marketing And Business Development Expenses [Line Items] | |||
Selling, and marketing expenses | $ 739 | $ 1,576 | $ 1,787 |
GENERAL AND ADMINISTRATIVE EX_3
GENERAL AND ADMINISTRATIVE EXPENSES (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
General And Administrative Expense [Line Items] | |||
General and administrative expenses | $ 16,219 | $ 28,586 | $ 32,365 |
Payroll and related expenses | |||
General And Administrative Expense [Line Items] | |||
General and administrative expenses | 7,035 | 10,521 | 11,974 |
Share-based payments | |||
General And Administrative Expense [Line Items] | |||
General and administrative expenses | 1,560 | 3,971 | 5,732 |
Professional services and supply chain | |||
General And Administrative Expense [Line Items] | |||
General and administrative expenses | 5,391 | 10,787 | 11,040 |
Medical affairs | |||
General And Administrative Expense [Line Items] | |||
General and administrative expenses | 818 | 1,214 | 1,600 |
Office-related expenses | |||
General And Administrative Expense [Line Items] | |||
General and administrative expenses | 958 | 1,434 | 1,438 |
Other | |||
General And Administrative Expense [Line Items] | |||
General and administrative expenses | $ 457 | $ 659 | $ 581 |
FINANCIAL INCOME (EXPENSES), _3
FINANCIAL INCOME (EXPENSES), net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
FINANCIAL INCOME (EXPENSES), net | |||
Fair value gains on derivative financial instruments | $ 13,422 | ||
Gains from the transfer of the rights in Movantik and extinguishment of debt obligations | $ 20,585 | ||
Other income | 210 | ||
Interest from bank deposits | 94 | 140 | $ 51 |
Financial income | 20,889 | 13,562 | 51 |
Interest for lease liabilities | 367 | 430 | 395 |
Issuance cost with respect of issuance of ADSs and warrants | 2,034 | 958 | |
Loss from changes in exchange rates | 115 | 40 | 28 |
Fair value loss on derivative financial instruments | 5,569 | ||
Day one loss on derivative financial instruments | 1,459 | ||
Interest expenses related to borrowing and payable in respect of intangible assets purchase | (40,903) | (16,172) | |
Other | 61 | 56 | 65 |
Financial expenses | 9,605 | 42,387 | 16,660 |
Financial income (expenses), net | $ 11,284 | $ (28,825) | $ (16,609) |
SEGMENT INFORMATION (Details)
SEGMENT INFORMATION (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Disclosure of operating segments | |||
Financial income (expenses), net | $ 11,284 | $ (28,825) | $ (16,609) |
Share-based compensation to employees and service providers | 1,647 | 5,675 | 10,212 |
Depreciation | (1,445) | (2,136) | (1,914) |
Amortization and impairment of intangible assets | 545 | 6,018 | 16,235 |
Gain from early termination of lease, net | 543 | ||
Other income | 44,064 | ||
Consolidated Comprehensive Income (Loss) | 23,916 | (71,669) | (97,744) |
Commercial Operations | |||
Disclosure of operating segments | |||
Adjusted EBITDA | (20,173) | (16,595) | (15,527) |
Research and Development | |||
Disclosure of operating segments | |||
Adjusted EBITDA | $ (8,165) | $ (12,420) | $ (37,247) |
SEGMENT INFORMATION - Major Cus
SEGMENT INFORMATION - Major Customers and Segment Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Disclosure of major customers | |||
Non-current assets | $ 6,907 | $ 72,970 | |
Intangible assets | 5,578 | 65,626 | |
Right-of-use assets | 989 | $ 6,692 | |
Israel | |||
Disclosure of major customers | |||
Non-current assets | 6,400 | ||
Intangible assets | 5,600 | ||
Right-of-use assets | 600 | ||
U.S. | |||
Disclosure of major customers | |||
Non-current assets | 500 | ||
Right-of-use assets | $ 400 | ||
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 | 30% | 32% | 32% |
Customer B | |||
Disclosure of major customers | |||
Percentage of revenue | 28% | 30% | 31% |
Customer C | |||
Disclosure of major customers | |||
Percentage of revenue | 37% | 33% | 32% |
EARNINGS (LOSS) PER ORDINARY _3
EARNINGS (LOSS) PER ORDINARY SHARE - Basic (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Basic | |||
Earnings (Loss) (U.S. dollars in thousands) | $ 23,916 | $ (71,669) | $ (97,744) |
Weighted average number of ordinary shares outstanding during the period (in thousands) | 2,591,222,000 | 616,299,000 | 465,273,000 |
Basic earnings (loss) per share (U.S. dollars) | $ 0.01 | $ (0.12) | $ (0.21) |
Ordinary shares underlying warrants excluded from diluted earnings (loss) per share | 508,836,400 | ||
Ordinary shares underlying options excluded from diluted earnings (loss) per share | 38,940,330 | ||
Ordinary shares underlying RSUs excluded from diluted earnings (loss) per share | 71,209,560 |
RELATED PARTIES - Key Managemen
RELATED PARTIES - Key Management Compensation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
RELATED PARTIES | |||
Salaries and other short-term employee benefits | $ 1,189 | $ 1,486 | $ 1,668 |
Post-employment benefits | 56 | 64 | 91 |
Share-based payments | 407 | 1,041 | 1,611 |
Other long-term benefits | $ 35 | $ 44 | $ 54 |
RELATED PARTIES - Balances with
RELATED PARTIES - Balances with Related Parties (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current liabilities | ||
Credit balance in "accrued expenses and other current liabilities" | $ 206 | $ 191 |
EVENTS SUBSEQUENT TO DECEMBER_2
EVENTS SUBSEQUENT TO DECEMBER 31, 2023 (Details) | 12 Months Ended | ||||||||
Apr. 03, 2024 USD ($) $ / shares shares | Jan. 26, 2024 USD ($) $ / shares shares | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) shares | Dec. 31, 2021 USD ($) | Mar. 21, 2024 $ / shares shares | Dec. 31, 2023 ₪ / shares shares | Nov. 29, 2023 $ / shares shares | Jul. 25, 2023 $ / shares shares | |
Disclosure of non-adjusting events after reporting period | |||||||||
Number of shares issued | 12,163 | 1,301,923 | |||||||
Exercise price of warrants | $ / shares | $ 59.20 | ||||||||
Proceeds from issuance | $ | $ 1,250,000 | $ 13,959,000 | $ 23,806,000 | $ 78,536,000 | |||||
Offering expenses | $ | $ 100,000 | ||||||||
Number of shares authorised | 400,000,000 | 200,000,000 | |||||||
Ordinary shares. | |||||||||
Disclosure of non-adjusting events after reporting period | |||||||||
Number of shares authorised | 1,594,000,000 | 39,994,000,000 | 19,994,000,000 | 19,994,000,000 | |||||
Par value per share | (per share) | $ 0.01 | ₪ 0.01 | $ 0.01 | ||||||
Preferred shares | |||||||||
Disclosure of non-adjusting events after reporting period | |||||||||
Number of shares authorised | 6,000,000 | 6,000,000 | |||||||
Par value per share | $ / shares | $ 0.01 | $ 0.01 | |||||||
ADS | |||||||||
Disclosure of non-adjusting events after reporting period | |||||||||
Number of shares issued | 10,000,000 | ||||||||
Exercise price of warrants | $ / shares | $ 1 | ||||||||
Warrants term | 5 years | ||||||||
Proceeds from issuance | $ | $ 8,000,000 | ||||||||
Offering expenses | $ | $ 900,000 | ||||||||
Registered Direct Offering | Warrants. | |||||||||
Disclosure of non-adjusting events after reporting period | |||||||||
Exercise price of warrants | $ / shares | $ 0.75 | ||||||||
Warrants term | 5 years | ||||||||
Class of warrant or right, number of securities called by warrants or rights | 2,144,487 | ||||||||
Registered Direct Offering | ADS | |||||||||
Disclosure of non-adjusting events after reporting period | |||||||||
Number of shares issued | 2,144,487 | 10,000,000 | |||||||
Share price | $ / shares | $ 0.58289 | $ 0.80 | |||||||
Major ordinary share transactions | |||||||||
Disclosure of non-adjusting events after reporting period | |||||||||
Class of warrant or right, number of securities called by warrants or rights | 600,000 |