Document and Entity Information
Document and Entity Information | 6 Months Ended |
Jun. 30, 2024 | |
Cover [Abstract] | |
Document Type | 6-K |
Document Period End Date | Jun. 30, 2024 |
Entity Registrant Name | RedHill Biopharma Ltd. |
Entity Central Index Key | 0001553846 |
Current Fiscal Year End Date | --12-31 |
Document Fiscal Year Focus | 2024 |
Document Fiscal Period Focus | Q2 |
Amendment Flag | false |
CONDENSED CONSOLIDATED INTERIM
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME (LOSS) - USD ($) shares in Thousands, $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME (LOSS) | ||
NET REVENUES | $ 2,572 | $ 5,395 |
COST OF REVENUES | 1,404 | 2,418 |
GROSS PROFIT | 1,168 | 2,977 |
RESEARCH AND DEVELOPMENT EXPENSES | 659 | 2,331 |
SELLING AND MARKETING EXPENSES | 3,487 | 9,632 |
GENERAL AND ADMINISTRATIVE EXPENSES | 5,470 | 9,335 |
OTHER INCOME | (42,993) | |
OPERATING INCOME (LOSS) | (8,448) | 24,672 |
FINANCIAL INCOME | 7,157 | 28,677 |
FINANCIAL EXPENSES | 1,797 | 2,347 |
FINANCIAL INCOME, net | 5,360 | 26,330 |
INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS) FOR THE PERIOD | $ (3,088) | $ 51,002 |
EARNINGS (LOSS) PER ORDINARY SHARE, basic (U.S. dollars) | $ 0 | $ 0.04 |
EARNINGS (LOSS) PER ORDINARY SHARE, diluted (U.S. dollars) | $ 0 | $ 0.04 |
WEIGHTED AVERAGE OF ORDINARY SHARE, Basic (in thousands) | 11,760,458 | 1,277,931 |
WEIGHTED AVERAGE OF ORDINARY SHARE, diluted (in thousands) | 11,760,458 | 1,277,931 |
CONDENSED CONSOLIDATED INTERI_2
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 7,277 | $ 5,569 |
Restricted cash | 739 | 790 |
Trade receivables | 974 | 2,591 |
Prepaid expenses and other receivables | 2,909 | 2,801 |
Inventory | 3,804 | 4,389 |
Total current assets | 15,703 | 16,140 |
NON-CURRENT ASSETS: | ||
Restricted cash | 143 | 147 |
Fixed assets | 147 | 193 |
Right-of-use assets | 469 | 989 |
Intangible assets | 5,562 | 5,578 |
Total non-current assets | 6,321 | 6,907 |
TOTAL ASSETS | 22,024 | 23,047 |
CURRENT LIABILITIES: | ||
Account payable | 1,912 | 3,278 |
Lease liabilities | 368 | 718 |
Accrued expenses and other current liabilities | 3,961 | 4,592 |
Allowance for deductions from revenue | 12,451 | 10,654 |
Derivative financial instruments | 2,541 | 741 |
Total current liabilities | 21,233 | 19,983 |
NON-CURRENT LIABILITIES: | ||
Lease liabilities | 190 | 455 |
Royalty obligation | 540 | 540 |
Total non-current liabilities | 730 | 995 |
TOTAL LIABILITIES | 21,963 | 20,978 |
EQUITY: | ||
Ordinary shares | 34,785 | 21,441 |
Additional paid-in capital | 375,333 | 388,363 |
Accumulated deficit | (410,057) | (407,735) |
TOTAL EQUITY | 61 | 2,069 |
TOTAL LIABILITIES AND EQUITY | $ 22,024 | $ 23,047 |
CONDENSED CONSOLIDATED INTERI_3
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY - USD ($) $ in Thousands | Ordinary shares. | Additional paid-in capital | Accumulated deficit | Total |
Balance at beginning of period at Dec. 31, 2022 | $ 2,835 | $ 382,625 | $ (433,860) | $ (48,400) |
Share-based compensation to employees and service providers | 849 | 849 | ||
Issuance of ordinary shares, net of expenses | 1,761 | (1,741) | 20 | |
Issuance of ordinary shares for vested RSUs | 24 | (24) | ||
Comprehensive income (loss) | 51,002 | 51,002 | ||
Balance at end of period at Jun. 30, 2023 | 4,620 | 380,860 | (382,009) | 3,471 |
Balance at beginning of period at Dec. 31, 2023 | 21,441 | 388,363 | (407,735) | 2,069 |
Share-based compensation to employees and service providers | 766 | 766 | ||
Issuance of ordinary shares, net of expenses | 13,135 | (12,821) | 314 | |
Issuance of ordinary shares for vested RSUs | 209 | (209) | ||
Comprehensive income (loss) | (3,088) | (3,088) | ||
Balance at end of period at Jun. 30, 2024 | $ 34,785 | $ 375,333 | $ (410,057) | $ 61 |
CONDENSED CONSOLIDATED INTERI_4
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
OPERATING ACTIVITIES: | ||
Comprehensive income (loss) | $ (3,088) | $ 51,002 |
Adjustments in respect of income and expenses not involving cash flow: | ||
Share-based compensation to employees and service providers | 229 | 849 |
Depreciation | 402 | 1,055 |
Amortization of intangible assets | 16 | 530 |
Gains from the transfer of rights in Movantik and extinguishment of debt obligations, (see below) | (56,082) | |
Gains from early termination of leases, net | (23) | (694) |
Fair value gains on derivative financial instruments | (7,108) | (8,071) |
Loss from modification of warrants terms as part of a new issuance, see note 3b | 1,084 | |
Issuance costs in respect of warrants | 1,497 | 922 |
Exchange differences and revaluation of bank deposits | (4) | (13) |
Total adjustments in respect of income and expenses not involving cash flow | (4,991) | (60,420) |
Changes in assets and liability items: | ||
Decrease in trade receivables | 1,617 | 31,618 |
Decrease (increase) in prepaid expenses and other receivables | (108) | 1,337 |
Decrease in inventories | 585 | 1,837 |
Decrease in accounts payable | (1,366) | (1,118) |
Decrease in accrued expenses and other liabilities | (631) | (10,545) |
Increase (decrease) in allowance for deductions from revenue | 1,797 | (31,486) |
Total changes in assets and liability items | 1,894 | (8,357) |
Net cash used in operating activities | (6,185) | (17,775) |
INVESTING ACTIVITIES: | ||
Purchase of fixed assets | (1) | (7) |
Net cash used in investing activities | (1) | (7) |
FINANCING ACTIVITIES: | ||
Proceeds from issuance of ordinary shares and warrants, net of issuance costs | 8,263 | 5,097 |
Repayment of payable in respect of intangible asset purchase | (6,555) | |
Decrease in restricted cash | 51 | 6,860 |
Payment of principal with respect to lease liabilities | (414) | (589) |
Net cash provided by financing activities | 7,900 | 4,813 |
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 1,714 | (12,969) |
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS | (6) | (3) |
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 5,569 | 19,968 |
BALANCE OF CASH AND CASH EQUIVALENTS AT THE END OF PERIOD | 7,277 | 6,996 |
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH | 38 | 123 |
SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH | 28 | 315 |
Acquisition of right-of-use assets by means of lease liabilities | 5 | 224 |
Decrease in lease liability (with corresponding decrease in right of use asset in amount of $170 in the six months ended June 30, 2024, and $4,117 in the six months ended June 30,2023) resulting from early termination of lease | $ 193 | 4,811 |
Decrease in Intangible asset | (59,503) | |
Decrease in Inventories | (4,233) | |
Decrease in Payable in respect of Intangible asset | 4,602 | |
Decrease in Borrowing | 115,216 | |
Gains from the transfer of the rights in Movantik and extinguishment of debt obligations | $ 56,082 |
CONDENSED CONSOLIDATED INTERI_5
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS (Parenthetical) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS | ||
Decrease in right of use asset | $ 170 | $ 4,117 |
GENERAL
GENERAL | 6 Months Ended |
Jun. 30, 2024 | |
GENERAL | |
General | NOTE 1 - GENERAL: a. General 1) RedHill Biopharma Ltd. (the “Company”), incorporated on August 3, 2009, together with its wholly-owned subsidiary, RedHill Biopharma Inc. (“RedHill Inc.”), incorporated in Delaware, U.S. on January 19, 2017, is a specialty biopharmaceutical company primarily focused on gastrointestinal (“GI”) diseases and infectious diseases. The Company’s American Depositary Shares (“ADSs”) were traded on the Nasdaq Capital Market from December 27, 2012, were listed on the Nasdaq Global Market (“Nasdaq”) from July 20, 2018, and have been again listed on the Nasdaq Capital Market since November 15, 2023. On March 23, 2023, the Company changed the ADS ratio from 1 ADS representing 10 ordinary shares to 1 ADS representing 400 ordinary shares. On August 20, 2024, after the condensed consolidated interim financial statements date, the Company changed the ADS to ordinary share ratio from 1 ADS representing 400 ordinary shares to 1 ADS representing 10,000 ordinary shares. The ADSs and per ADS amounts in these interim financial statements reflect the old ratio of 1 ADS to 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 condensed consolidated interim 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 F ebruary 1, 2023, the Company commercialized Movantik® in the U.S, for the treatment of opioid-induced constipation. See also note 15(6) in the annual financial statements as of December 31, 2023 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 (see also note 10). The Company also continues to advance the development of part of its late-stage therapeutic candidates. 3) Through June 30, 202 4 , the Company has an accumulated deficit and negative working capital, and its activities have been funded primarily through public and private offerings of the Company’s securities and secured borrowing (now fully extinguished, see note 15(6) in the annual financial statements as of December 31, 2023 ( . There is no assurance that the Company’s business will generate sustainable positive cash flows to fund its business. The Company plans to further fund its future operations through commercialization and out-licensing of its therapeutic candidates, commercialization of in-licensed or acquired products and raising additional capital through equity or debt financing or through other non-dilutive financing. Furthermore, the Company 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. The Company’s current cash resources are not sufficient to complete the research and development of any of its therapeutic candidates and to fully support its commercial operations until generation of sustainable positive cash flows. Management expects that the Company will incur additional losses as it continues to focus its resources on advancing the development of its therapeutic candidates, as well as advancing its commercial operations, based on a prioritized plan that will result in negative cash flows from operating activities. Management believes that there is presently insufficient funding available to allow the Company to fund its activities for a period exceeding one year from the date of this filing. These conditions and events indicate that a material uncertainty exists that may cast significant doubt (or raise substantial doubt as contemplated by PCAOB standards) about the Company’s ability to continue as a going concern. The accompanying condensed consolidated interim financial statements have been prepared assuming that the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty. 4) In October 2023, Israel was attacked by a terrorist organization and entered a state of war. As of the date of these condensed consolidated interim financial statements , the war in Israel is ongoing and continues to evolve. During six months ended of June 30,2024, the impact of this war on the Company results and financial condition was immaterial, but such impact may increase . b. Approval of the condensed consolidated interim financial statements: These condensed consolidated interim financial statements were approved by the Board of Directors (the "BoD") on August 28, 2024. |
BASIS OF PREPARATION OF THE CON
BASIS OF PREPARATION OF THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS AND SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 2024 | |
BASIS OF PREPARATION OF THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS AND SIGNIFICANT ACCOUNTING POLICIES | |
BASIS OF PREPARATION OF THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS AND SIGNIFICANT ACCOUNTING POLICIES | NOTE 2 - BASIS OF PREPARATION OF THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS AND SIGNIFICANT ACCOUNTING POLICIES : a. BASIS OF PREPARATION The Company’s condensed consolidated interim financial statements for the six months ended June 30, 2024 (the "Condensed Consolidated Interim Financial Statements"), have been prepared in accordance with International Accounting Standard IAS 34, “Interim Financial Reporting ”. These Condensed Consolidated Interim Financial Statements, that are unaudited, do not include all the information and disclosures that would otherwise be required in a complete set of annual financial statements and should be read in conjunction with the annual financial statements as of December 31, 2023, and their accompanying notes, which have been prepared in accordance with International Financial Reporting Standards (“IFRS”) as published by the International Accounting Standards Board (“IASB”). The results of operations for the six months ended June 30, 2024, are not necessarily indicative of the results that may be expected for the entire fiscal year or for any other interim period . b. SIGNIFICANT ACCOUNTING POLICIES 1) General The accounting policies applied in the preparation of the Condensed Consolidated Interim Financial Statements are consistent with those applied in the preparation of the annual financial statements as of December 31, 2023, except for the reclassification of derivative financial instruments from non-current liabilities to current liabilities, as described in note 2b(2). 2) New international financial reporting standards, amendments to standards and new interpretations Classification of Liabilities as Current or Non-Current (Amendment to IAS 1) The narrow-scope amendments to IAS 1, “Presentation of Financial Statements,” clarify that liabilities are classified as either current or noncurrent, depending on the rights that exist at the end of the reporting period. Classification is unaffected by the entity’s expectations or events after the reporting date. The amendments also clarify what IAS 1 means when it refers to the settlement’ of a liability. The amendments may affect the classification of liabilities, particularly for entities that previously considered management’s intentions to determine classification and for some liabilities that can be converted into equity. The Company adopted these amendments effective January 1, 2024. The impact on the Company’s financial statements of these amendments was the reclassification of the Company’s derivative financial instruments from non-current to current as of its effective date. The Company has retrospectively applied the amendments in these interim financial statements and, accordingly, has retrospectively adjusted the comparative balance sheet for December 31, 2023 to reclassify its warrant liabilities ($741 as of December 31, 2023) from non-current to current. Adoption of the amendments had no other impact on the Company’s financial statements. IFRS 18, Presentation and Disclosure in the Financial Statements This standard replaces the international accounting standard IAS 1, “Presentation of Financial Statements.” As part of the new disclosure requirements, companies will be required to present new defined subtotals in the statements of income, as follows: (1) operating profit and (2) profit before financing and tax. In addition, income statement items will be classified into three defined categories: operating, investment and financing. The standard also includes a requirement to provide a separate disclosure in the financial statements regarding the use of management-defined performance measures (“non-GAAP measures”), and specific instructions were added for the grouping and splitting of items in the financial statements and in the notes to the financial statements. IFRS 18 is effective for annual reporting periods beginning on or after January 1, 2027, with an option for early adoption. |
SIGNIFICANT EVENTS DURING THE C
SIGNIFICANT EVENTS DURING THE CURRENT REPORTING PERIOD | 6 Months Ended |
Jun. 30, 2024 | |
SIGNIFICANT EVENTS DURING THE CURRENT REPORTING PERIOD | |
SIGNIFICANT EVENTS DURING THE CURRENT REPORTING PERIOD | NOTE 3 - SIGNIFICANT EVENTS DURING THE CURRENT REPORTING PERIOD: a. On January 26, 2024, the Company issued 10,000,000 ADSs at a purchase price of $ 0.80 per ADS and warrants to purchase 10,000,000 ADSs at an exercise price of $ 1.00 per ADS. These warrants may be exercised in cash or on a cashless basis, are immediately exercisable, and expire in five years . The Company also issued to the placement agent warrants to purchase 600,000 ADSs under the same terms. The gross proceeds from the offering were $ 8 million, before deducting approximately $ 0.9 million in fees and expenses. The warrants were classified as a financial liability due to a net settlement provision. These derivatives were recognized and subsequently measured at fair value through profit or loss. Upon initial recognition the fair value of the warrants was adjusted to reflect the unrecognized day 1 loss. This unrecognized day 1 loss is amortized over the warrants’ contractual life. Consequently, $ 0.9 million of issuance costs allocated to the warrants, were included directly in the Consolidated Statements of Comprehensive Income (Loss). See also note 7. b. 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. c. On April 3, 2024, the Company issued 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. These warrants may be exercised in cash or on a cashless basis, are immediately exercisable and expire in five years . The gross proceeds from the offering were $ 1.25 million, before deducting offering expenses approximately $ 0.1 million in expesnses. The warrants were classified as a financial liability due to a net settlement provision. These derivatives were recognized and subsequently measured at fair value through profit or loss. The consideration, net of issue expenses, was allocated to the various issued instruments. Out of the gross consideration, $ 0.9 million was allocated to the warrants. The remainder of approximately $ 0.35 million was allocated to equity. Issuance expenses allocated to the liability instruments were recorded directly in the Consolidated Statements of Comprehensive Income (Loss) and , while those allocated to equity were recorded against additional paid in capital. See also note 7. |
ALLOWANCE FOR DEDUCTIONS FROM R
ALLOWANCE FOR DEDUCTIONS FROM REVENUES | 6 Months Ended |
Jun. 30, 2024 | |
ALLOWANCE FOR DEDUCTIONS FROM REVENUES | |
ALLOWANCE FOR DEDUCTIONS FROM REVENUES | NOTE 4 : - ALLOWANCE FOR DEDUCTIONS FROM REVENUES: The following table shows the movement of the allowance for deductions from revenues: Rebates and patient discount programs Product returns Total U.S. dollars in thousands As of January 1, 2024 8,087 2,567 10,654 Increases 4,565 103 4,668 Decreases (utilized) (3,184) (518) (3,702) Adjustments 423 408 831 As of June 30, 2024 9,891 2,560 12,451 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 16,918 759 17,677 Decreases (utilized) (48,598) (1,072) (49,670) Adjustments 910 (403) 507 As of June 30, 2023 15,866 518 16,384 |
SHARE-BASED PAYMENTS
SHARE-BASED PAYMENTS | 6 Months Ended |
Jun. 30, 2024 | |
SHARE-BASED PAYMENTS | |
SHARE-BASED PAYMENTS | NOTE 5 - SHARE-BASED PAYMENTS: 1. 2. options . |
NET REVENUES
NET REVENUES | 6 Months Ended |
Jun. 30, 2024 | |
NET REVENUES | |
NET REVENUES | NOTE 6 - NET REVENUES: Six Months Ended June 30, 2024 2023 U.S dollars in thousands Sales of products 2,572 5,395 During the six months ended June 30, 2024, and June 30, 2023, the Company recorded contra-revenues of ($0.9) million and ($0.2) million for Movantik®, respectively, primarily due to returns following its divestiture on February 1, 2023 (see note 15(6) in the annual financial statements as of December 31, 2023). Correspondingly, net revenues from other products (mainly Talicia®) were $3.5 million in the first half of 2024, including $0.5 million from sales to Gaelan Medical Trade LLC, which has an exclusive license for Talicia® in the UAE (see note 15(7) in the annual financial statements as of December 31, 2023). In the first half of 2023, net revenues from other products (mainly Talicia®) were $5.6 million, all from U.S. sales . |
FINANCIAL INSTRUMENTS
FINANCIAL INSTRUMENTS | 6 Months Ended |
Jun. 30, 2024 | |
FINANCIAL INSTRUMENTS | |
FINANCIAL INSTRUMENTS | NOTE 7 - FINANCIAL INSTRUMENTS: a. The Company’s derivative financial liability, represented by warrants, is measured at fair value and classified as level 3. Fair value adjustments are recognized in profit or loss as financial income or expenses. The following table presents the change in this level 3 derivative liability for the six months ended June 30, 2024, and June 30, 2023 : Derivative financial instruments Six Months Ended June 30, 2024 2023 U.S. dollars in thousands Balance at beginning of the period 741 2,623 Initial recognition of financial liability 9,860 7,083 Initial recognition of unrecognized day 1 loss (952) — Fair value adjustments recognized in profit or loss (7,108) (8,071) Balance at end of the period 2,541 1,635 The fair value of the warrants is computed using the Black-Scholes model. As of June 30,2024, it is based on the ADS price on that date and the following key parameters: risk-free interest rate of 4.35%-4.48% and volatility of 120.5%-133.6%. As of June 30,2023, it is based on the ADS price on that date and the following key parameters: risk-free interest rate of 4.17%-5.47% and volatility of 86.6%-99.5%. b. . |
SEGMENT INFORMATION
SEGMENT INFORMATION | 6 Months Ended |
Jun. 30, 2024 | |
SEGMENT INFORMATION | |
SEGMENT INFORMATION | NOTE 8 - 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: Six Months Ended June 30, 2024 2023 U.S. dollars in thousands Commercial Operations Segment Adjusted EBITDA (4,681) (11,031) Research And Development Adjusted EBITDA (3,143) (5,550) Financial income, net 5,360 26,330 Share-based compensation to employees and service providers (229) (849) Depreciation (402) (1,055) Amortization of intangible assets (16) (530) Gain from early termination of lease, net 23 694 Other income — 42,993 Consolidated Comprehensive income (loss) (3,088) 51,002 |
EARNING (LOSS) PER SHARE
EARNING (LOSS) PER SHARE | 6 Months Ended |
Jun. 30, 2024 | |
EARNING (LOSS) PER SHARE | |
EARNING (LOSS) PER SHARE | NOTE 9 - EARNING (LOSS) PER SHARE: The basic and diluted earnings (loss) per share are the same since the effect of all potentially diluted ordinary shares for all reporting periods is anti-dilutive. |
EVENT SUBSEQUENT TO JUNE 30, 20
EVENT SUBSEQUENT TO JUNE 30, 2024 | 6 Months Ended |
Jun. 30, 2024 | |
EVENT SUBSEQUENT TO JUNE 30,2024 | |
EVENT SUBSEQUENT TO JUNE 30, 2024 | NOTE 10 - EVENT SUBSEQUENT TO JUNE 30, 2024: On July 15, 2024, the Company and RedHill Inc signed a Global Termination Agreement with Movantik Acquisition Co., Valinor Pharma, LLC, and HCR Redhill SPV, LLC, affiliates of HCRM (the “Global Termination Agreement”). This agreement terminates the Credit Agreement from February 23, 2020, which was amended on February 2, 2023, as part of the transaction where the rights to Movantik® were sold to HCRM in exchange for extinguishing all debt obligations under the Credit Agreement. The February 2023 agreement had placed a lien Talicia® and Aemcolo® assets and established an escrow account with restricted funds for Movantik® liabilities (for further details, see note 1(a)(2) above and notes 14(a), 15(4), 15(5), and 15(6) to the annual financial statements as of December 31, 2023). The Global Termination Agreement terminates all existing credit ties, removing the aforementioned lien and restoring control over the restricted escrow funds. The Company received approximately $9.9 million in cash and gained full control over $0.7 million previously held in the restricted account. Under the Global Termination Agreement, the Company assumed certain liabilities related to Movantik® from the other parties and settled additional liabilities between the parties. This resulted in an increase of approximately $ |
BASIS OF PREPARATION OF THE C_2
BASIS OF PREPARATION OF THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS AND SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Basis of preparation | The Company’s condensed consolidated interim financial statements for the six months ended June 30, 2024 (the "Condensed Consolidated Interim Financial Statements"), have been prepared in accordance with International Accounting Standard IAS 34, “Interim Financial Reporting ”. These Condensed Consolidated Interim Financial Statements, that are unaudited, do not include all the information and disclosures that would otherwise be required in a complete set of annual financial statements and should be read in conjunction with the annual financial statements as of December 31, 2023, and their accompanying notes, which have been prepared in accordance with International Financial Reporting Standards (“IFRS”) as published by the International Accounting Standards Board (“IASB”). The results of operations for the six months ended June 30, 2024, are not necessarily indicative of the results that may be expected for the entire fiscal year or for any other interim period . |
ALLOWANCE FOR DEDUCTIONS FROM_2
ALLOWANCE FOR DEDUCTIONS FROM REVENUES (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
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, 2024 8,087 2,567 10,654 Increases 4,565 103 4,668 Decreases (utilized) (3,184) (518) (3,702) Adjustments 423 408 831 As of June 30, 2024 9,891 2,560 12,451 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 16,918 759 17,677 Decreases (utilized) (48,598) (1,072) (49,670) Adjustments 910 (403) 507 As of June 30, 2023 15,866 518 16,384 |
NET REVENUES (Tables)
NET REVENUES (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
NET REVENUES | |
Schedule of net revenues | Six Months Ended June 30, 2024 2023 U.S dollars in thousands Sales of products 2,572 5,395 |
FINANCIAL INSTRUMENTS (Tables)
FINANCIAL INSTRUMENTS (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
FINANCIAL INSTRUMENTS | |
Schedule of change in derivative financial instrument | Derivative financial instruments Six Months Ended June 30, 2024 2023 U.S. dollars in thousands Balance at beginning of the period 741 2,623 Initial recognition of financial liability 9,860 7,083 Initial recognition of unrecognized day 1 loss (952) — Fair value adjustments recognized in profit or loss (7,108) (8,071) Balance at end of the period 2,541 1,635 |
SEGMENT INFORMATION (Tables)
SEGMENT INFORMATION (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
SEGMENT INFORMATION | |
Schedule of segment profitability and reconciliation to consolidated net income (loss) and comprehensive income (loss) | Six Months Ended June 30, 2024 2023 U.S. dollars in thousands Commercial Operations Segment Adjusted EBITDA (4,681) (11,031) Research And Development Adjusted EBITDA (3,143) (5,550) Financial income, net 5,360 26,330 Share-based compensation to employees and service providers (229) (849) Depreciation (402) (1,055) Amortization of intangible assets (16) (530) Gain from early termination of lease, net 23 694 Other income — 42,993 Consolidated Comprehensive income (loss) (3,088) 51,002 |
GENERAL (Details)
GENERAL (Details) - ADS - shares | Aug. 20, 2024 | Mar. 23, 2023 | Mar. 22, 2023 |
General [Line Items] | |||
Number of Ordinary Shares Issued in Exchange of American Depository Receipts | 400 | 10 | |
Major ordinary share transactions | |||
General [Line Items] | |||
Number of Ordinary Shares Issued in Exchange of American Depository Receipts | 10,000 |
BASIS OF PREPARATION OF THE C_3
BASIS OF PREPARATION OF THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS AND SIGNIFICANT ACCOUNTING POLICIES (Details) | Dec. 31, 2023 USD ($) |
IAS 1 Amendments | |
Disclosure of expected impact of initial application of new standards or interpretations [line items] | |
Reclassification Of Warrant Liability | $ 741 |
SIGNIFICANT EVENTS DURING THE_2
SIGNIFICANT EVENTS DURING THE CURRENT REPORTING PERIOD - Equity Offerings (Details) | 6 Months Ended | ||||
Apr. 03, 2024 USD ($) $ / shares shares | Jan. 26, 2024 USD ($) $ / shares shares | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Mar. 21, 2024 ILS (₪) ₪ / shares shares | |
Disclosure of classes of share capital [line items] | |||||
Financial expense | $ 1,797,000 | $ 2,347,000 | |||
Proceeds from issuance of shares | $ 1,250,000 | $ 8,000,000 | |||
Warrants issued | shares | 600,000 | ||||
Placement agent fees and offering expenses. | 100,000 | $ 900,000 | |||
Authorised Share Capital | ₪ | ₪ 400,000,000 | ||||
Warrants. | |||||
Disclosure of classes of share capital [line items] | |||||
Exercise price of warrants | $ / shares | $ 1 | ||||
Proceeds from issuance of shares | $ 900,000 | ||||
Warrants issued | shares | 2,144,487 | 10,000,000 | |||
Warrants exercise price | $ / shares | $ 0.75 | ||||
Warrants term | 5 years | 5 years | |||
Placement agent fees and offering expenses. | $ 900,000 | ||||
Equity component | |||||
Disclosure of classes of share capital [line items] | |||||
Proceeds from issuance of shares | $ 350,000 | ||||
ADS | |||||
Disclosure of classes of share capital [line items] | |||||
Number of shares issued | shares | 2,144,487 | 10,000,000 | |||
Purchase price (per share) | $ / shares | $ 0.58289 | $ 0.80 | |||
Ordinary shares | |||||
Disclosure of classes of share capital [line items] | |||||
Number of shares authorised | shares | 39,994,000,000 | ||||
Par value per share | ₪ / shares | ₪ 0.01 | ||||
Preference shares [member] | |||||
Disclosure of classes of share capital [line items] | |||||
Number of shares authorised | shares | 6,000,000 | ||||
Par value per share | ₪ / shares | ₪ 0.01 |
ALLOWANCE FOR DEDUCTIONS FROM_3
ALLOWANCE FOR DEDUCTIONS FROM REVENUES (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Disclosure of other provisions [line items] | ||
Balance at Beginning of period | $ 10,654 | $ 47,870 |
Increases | 4,668 | 17,677 |
Decreases (Utilized) | (3,702) | (49,670) |
Adjustments | 831 | 507 |
Balance at end of period | 12,451 | 16,384 |
Rebates and patient discount programs | ||
Disclosure of other provisions [line items] | ||
Balance at Beginning of period | 8,087 | 46,636 |
Increases | 4,565 | 16,918 |
Decreases (Utilized) | (3,184) | (48,598) |
Adjustments | 423 | 910 |
Balance at end of period | 9,891 | 15,866 |
Product returns | ||
Disclosure of other provisions [line items] | ||
Balance at Beginning of period | 2,567 | 1,234 |
Increases | 103 | 759 |
Decreases (Utilized) | (518) | (1,072) |
Adjustments | 408 | (403) |
Balance at end of period | $ 2,560 | $ 518 |
SHARE-BASED PAYMENTS (Details)
SHARE-BASED PAYMENTS (Details) | 6 Months Ended | |
Jun. 24, 2024 USD ($) shares installment | Jun. 30, 2024 USD ($) shares | |
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||
Shares forfeited, reversed expenses | $ | $ 300,000 | |
RSUs | ||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||
Number of RSUs granted | 1,044,000 | |
Number of RSU forfeited | 24,000 | |
Number Of RSU Quarterly Installments | installment | 8 | |
Fair value of RSU grant | $ | $ 400,000 | |
RSUs | Directors and chief executive officer | ||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||
Number of RSUs granted | 383,000 | |
Fair value of RSU grant | $ | $ 100,000 | |
Share options | ||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||
Share options forfeited | 24,000 |
NET REVENUES (Details)
NET REVENUES (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Revenues | ||
Sale of products | $ 2,572,000 | $ 5,395,000 |
Talicia | ||
Revenues | ||
Net Revenue | 3,500,000 | 5,600,000 |
Talicia | Gaelan Medical Trade LLC | ||
Revenues | ||
Net Revenue | 500,000 | |
Movantik | ||
Revenues | ||
Contra Revenue For Movantik | $ (900,000) | $ (200,000) |
FINANCIAL INSTRUMENTS (Details)
FINANCIAL INSTRUMENTS (Details) | 6 Months Ended | |
Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | |
Financial instruments | ||
Balance at beginning of the period | $ 20,978,000 | |
Balance at the end of the period | $ 21,963,000 | |
Risk-free interest rate | Minimum | ||
Financial instruments | ||
Significant unobservable input | 4.48 | 4.17 |
Risk-free interest rate | Maximum | ||
Financial instruments | ||
Significant unobservable input | 4.35 | 5.47 |
Volatility | Minimum | ||
Financial instruments | ||
Significant unobservable input | 120.5 | 86.6 |
Volatility | Maximum | ||
Financial instruments | ||
Significant unobservable input | 133.6 | 99.5 |
Level 3 | At fair value | Financial liabilities at fair value through profit or loss | Warrants | ||
Financial instruments | ||
Balance at beginning of the period | $ 741,000 | $ 2,623,000 |
Initial recognition of financial liability | 9,860,000 | 7,083,000 |
Initial recognition of unrecognized day 1 loss | (952,000) | |
Fair value adjustments recognized in profit or loss | (7,108,000) | (8,071,000) |
Balance at the end of the period | $ 2,541,000 | $ 1,635,000 |
SEGMENT INFORMATION (Details)
SEGMENT INFORMATION (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
SEGMENT INFORMATION | ||
Commercial Operations Segment Adjusted EBITDA | $ (4,681) | $ (11,031) |
Research And Development Adjusted EBITDA | (3,143) | (5,550) |
Financial income, net | 5,360 | 26,330 |
Share-based compensation to employees and service providers | (229) | (849) |
Depreciation | (402) | (1,055) |
Amortization of intangible assets | (16) | (530) |
Gain from early termination of lease, net | 23 | 694 |
Other income | 42,993 | |
Consolidated Comprehensive income (loss) | $ (3,088) | $ 51,002 |
EVENT SUBSEQUENT TO JUNE 30,202
EVENT SUBSEQUENT TO JUNE 30,2024 (Details) - The Agreement - Movantik Acquisition Co, Valinor Pharma, LLC, and HCR Redhill SPV, LLC | Jul. 15, 2024 USD ($) |
Disclosure of non-adjusting events after reporting period | |
Proceeds received following global termination agreement | $ 9,900,000 |
Restricted cash and cash equivalents | 700,000 |
Increase in future obligations | $ 12,200,000 |