{"url_path":"/sec/rdhl/10-k/2026/item-15","section_key":"item-15","section_title":"Item 15 CONTROLS AND PROCEDURES**","topic":"sec","document":{"doc_type":"20-F","doc_date":"2026-04-27","source_url":"https://www.sec.gov/Archives/edgar/data/1553846/0001104659-26-049055-index.html","accession_number":"0001104659-26-049055","cik":"0001553846","ticker":"RDHL","issuer_name":"RedHill Biopharma Ltd.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1553846/0001104659-26-049055-index.html","primary_entity_key":"0001553846","primary_entity_name":"RedHill Biopharma Ltd."},"word_count":976,"has_tables":true,"body_markdown":"**ITEM 15.         CONTROLS AND PROCEDURES**\n\n**(a)**\n\n**Disclosure Controls and Procedures**\n\nWe, together with the participation of our Chief Executive Officer and Chief Financial Officer, performed an evaluation of the effectiveness of our disclosure controls and procedures as of December 31, 2025. Our disclosure controls and procedures are designed to ensure that information required to be disclosed to the SEC is recorded, processed, summarized and reported within the time period specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act, is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Based on the evaluation, our management, including our Chief Executive Officer and Chief Financial Officer, have concluded that our disclosure controls and procedures (as defined in Rules 13a - 15(e) and 15d - 15(e) of the Exchange Act) as of the end of the period covered by this Annual Report were not effective. This assessment reflects a material weakness in internal control over financial reporting that was previously identified in 2022 and disclosed in our Annual Reports on Form 20-F for the years ended December 31, 2022, 2023 and 2024. While we have implemented a remediation plan, as of December 31, 2025, we had not yet concluded that the material weakness had been fully remediated.\n\n**(b)**\n\n**Management’s Annual Report on Internal Control over Financial Reporting**\n\nOur management, under the supervision of our Chief Executive Officer and Chief Financial Officer, is responsible for establishing and maintaining adequate internal control over our financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act. The Company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. Internal control over financial reporting includes policies and procedures that:\n\n●pertain to the maintenance of records that in reasonable detail accurately and fairly reflect our transactions and asset dispositions;\n\n●provide reasonable assurance that transactions are recorded as necessary to permit the preparation of our financial statements in accordance with generally accepted accounting principles;\n\n●provide reasonable assurance that receipts and expenditures are made only in accordance with authorizations of our management and board of directors (as appropriate); and\n\n●provide reasonable assurance regarding the prevention or timely detection of unauthorized acquisition, use or disposition of assets that could have a material effect on our financial statements.\n\n162\n\n[Table of Contents](#TOC)\n\nDue to its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. In addition, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.\n\nUnder the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we assessed the effectiveness of our internal control over financial reporting as of December 31, 2025, based on the framework for Internal Control-Integrated Framework set forth by The Committee of Sponsoring Organizations of the Treadway Commission (COSO) (2013).\n\nBased on our assessment, management has concluded that our internal control over financial reporting was not effective as of December 31, 2025.\n\nA material weakness is defined as a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. A material weakness in internal control over financial reporting was previously identified in 2022 and disclosed in our Annual Reports on Form 20-F for the years ended December 31, 2022, 2023 and 2024  relating to lack of sufficient controls which impacted the calculation of allowance for deductions from revenues. We lacked enough financial reporting personnel with an appropriate level of knowledge, experience, and training commensurate with our financial reporting requirements. This control deficiency contributed to the fact that not all data and information available to us was taken into consideration. While we have implemented a remediation plan, we have not yet conclusively determined that the material weakness has been fully remediated as of December 31, 2025.\n\n**Remediation Efforts**\n\nOur management, with the support of external experts, in collaboration with our internal auditor and with the oversight of the Audit Committee of the Board of Directors, has continued the process of remediating the material weakness. We have made further progress in implementing changes to our internal control over financial reporting and are committed to maintaining a strong internal control environment. The actions taken include:\n\n●Enhancing and supplementing the finance team with resources with knowledge and experience in internal control over financial reporting, including individuals responsible for the design and implementation of internal controls.\n\n●Designing and implementing additional formal policies, procedures and documentation to ensure transactions are properly initiated, recorded, processed, reported, and appropriately authorized and approved, including enhancement to our internal review procedures.\n\nWhile we have made progress in implementing our remediation plan , we have not yet concluded that the material weakness has been fully remediated as of December 31, 2025.\n\n**(c)**\n\n**Attestation Report of Registered Public Accounting Firm**\n\nNot applicable.\n\n**(d)**\n\n**Changes in Internal Control Over Financial Reporting**\n\nOther than the remedial measures we are currently in the process of implementing as described above, there were no material changes in our internal control over financial reporting that occurred during the year ended December 31, 2025, that have materially affected or are reasonably likely to materially affect our internal control over financial reporting.\n\n​\n\n163\n\n[Table of Contents](#TOC)"}