RedHill Biopharma Ltd ADR 2026年年度报告和过渡报告

TABLE OF CONTENTS ITEM 1.IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS7ITEM 2.OFFER STATISTICS AND EXPECTED TIMETABLE7ITEM 3.KEY INFORMATION7ITEM 4.INFORMATION ON THE COMPANY65ITEM 4A. UNRESOLVED STAFF COMMENTS109ITEM 5.OPERATING AND FINANCIAL REVIEW AND PROSPECTS109ITEM 6.DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES126ITEM 7.MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS143ITEM 8.FINANCIAL INFORMATION144ITEM 9.THE OFFER AND LISTING145ITEM 10. ADDITIONAL INFORMATION146ITEM 11.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK160ITEM 12.DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES160ITEM 13.DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES162ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS ANDUSE OF PROCEEDS162ITEM 15. CONTROLS AND PROCEDURES162ITEM 16.[RESERVED]164ITEM16A.AUDIT COMMITTEE FINANCIAL EXPERT164ITEM16B.CODE OF ETHICS164ITEM16C.PRINCIPAL ACCOUNTANT FEES AND SERVICES164ITEM16D.EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES164ITEM16E.PURCHASESOF EQUITY SECURITIES BY THE ISSUER AND AFFILIATEDPURCHASERS165ITEM16F.CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT165ITEM16G.CORPORATE GOVERNANCE165ITEM16H.MINE SAFETY DISCLOSURE166ITEM 16I.DISCLOSUREREGARDINGFOREIGNJURISDICTIONSTHAT PREVENTINSPECTIONS166ITEM 16J.INSIDER TRADING POLICIES166ITEM16K.CYBERSECURITY166ITEM 17. FINANCIAL STATEMENTS167ITEM 18. FINANCIAL STATEMENTS167ITEM 19. EXHIBITS167GLOSSARY OF TERMS168EXHIBIT INDEX169SIGNATURES173 Unless the context otherwise requires, all references to “RedHill,” “we,” “us,” “our,” the “Company” andsimilar designations refer to RedHill Biopharma Ltd. and its wholly owned subsidiary, RedHill BiopharmaInc. (“RedHill U.S.”). The term “including” means “including but not limited to”, whether or not explicitlyso stated. The term “NIS” refers to New Israeli Shekels, the lawful currency of the State of Israel, the terms“dollar”, “US$”, “$” or “U.S.” refer to U.S. dollars, the lawful currency of the United States of America.Our functional and presentation currency is the U.S. dollar. Unless otherwise indicated, U.S. dollar amountsherein (other than amounts originally receivable or payable in dollars) have been translated for theconvenience of the reader from the original NIS amounts at the representative rate of exchange as of April24, 2026 ($1 = NIS 3.0030). The dollar amounts presented should not be construed as representing amountsthat are receivable or payable in dollars or convertible into dollars, unless otherwise indicated. Foreigncurrency transactions in currencies other than U.S. dollars are translated in this Annual Report (as definedbelow) into U.S. dollars using exchange rates in effect at the date of the transactions. References to “Talicia Holdings Inc.” or “THI” refer to our jointly controlled equity-method investee, inwhich we hold a 70% equity interest. THI is not consolidated in our financial statements. Unlessotherwise indicated or the context requires,the term“therapeutic candidates”refers toinvestigational drug products that are still in development and have not been approved by the United StatesFood and Drug Administration (“FDA”) or other relevant regulatory authority and the term “commercialproducts” means products approved by the FDA that we or our subsidiaries, collaborators and affiliatescommercialize or promote from time to time. FORWARD-LOOKING STATEMENTS Some of the statements under the sections entitled “Item 3. Key Information – Risk Factors,” “Item 4.Information on the Company,” “Item 5. Operating and Financial Review and Prospects” and elsewhere inthis Annual Report on Form 20-F (the “Annual Report”) may include forward-looking statements. Thesestatements involve known and unknown risks, uncertainties and other factors that may cause our actualresults, performance or achievements to be materially different from any future results, performance orachievements expressed or implied by the forward-looking statements. In some cases, you can identifyforward-looking statements by terms, including “anticipates,” “believes,” “could,” “estimates,” “expects,”“intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would,” and similarexpressions intended to identify forward-looking statements. Forward-looking statements reflect our currentviews with respect to future events and are based on assumptions and subject to risks and uncertainties,many of which are beyond the Company’s control and cannot be predicted or quantified. In addition, thesection of this Annual Report entitled, “Item 4. Information on the Company”, contains informationobtained from independent industry and other sources that we may not have independently validated. Youshould not put undue reliance on any forward-looking statements. Unless we are required to do so underU.S. federal securities laws or other applicable laws, we do not intend to update or revise any forward-looking statements. Factors that could cause our actual results to differ ma