RedHill Biopharma Ltd ADR 2025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 COMPANY63ITEM4A.UNRESOLVED STAFF COMMENTS103ITEM 5.OPERATING AND FINANCIAL REVIEW AND PROSPECTS103ITEM 6.DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES117ITEM 7.MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS137ITEM 8.FINANCIAL INFORMATION138ITEM 9.THE OFFER AND LISTING139ITEM 10.ADDITIONAL INFORMATION139ITEM 11.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKETRISK154ITEM 12.DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES154ITEM 13.DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES156ITEM 14.MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERSAND USE OF PROCEEDS156ITEM 15.CONTROLS AND PROCEDURES156ITEM 16.[RESERVED]158ITEM16A.AUDIT COMMITTEE FINANCIAL EXPERT158ITEM16B.CODE OF ETHICS158ITEM16C.PRINCIPAL ACCOUNTANT FEES AND SERVICES158ITEM16D.EXEMPTIONSFROMTHELISTINGSTANDARDSFORAUDITCOMMITTEES158ITEM16E.PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATEDPURCHASERS159ITEM16F.CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT159ITEM16G.CORPORATE GOVERNANCE159ITEM16H.MINE SAFETY DISCLOSURE160ITEM16I.DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENTINSPECTIONS160ITEM16J.INSIDER TRADING POLICIES160ITEM16K.CYBERSECURITY160ITEM 17.FINANCIAL STATEMENTS161ITEM 18.FINANCIAL STATEMENTS161ITEM 19.EXHIBITS161GLOSSARY OF TERMS162EXHIBIT INDEX163 Unless the context otherwise requires, all references to “RedHill,” “we,” “us,” “our,” the “Company”and similar designations refer to RedHill Biopharma Ltd. and its wholly owned subsidiary, RedHillBiopharma Inc. (“RedHill U.S.”). The term “including” means “including but not limited to”,whether or not explicitly so stated. The term “NIS” refers to New Israeli Shekels, the lawful currencyof the State of Israel, the terms “dollar”, “US$”, “$” or “U.S.” refer to U.S. dollars, the lawfulcurrency of the United States of America. Our functional and presentation currency is the U.S. dollar.Unless otherwise indicated, U.S. dollar amounts herein (other than amounts originally receivable orpayable in dollars) have been translated for the convenience of the reader from the original NISamounts at the representative rate of exchange as of April 8, 2025 ($1 = NIS 3.766). The dollaramounts presented should not be construed as representing amounts that are receivable or payable indollars or convertible into dollars, unless otherwise indicated. Foreign currency transactions incurrencies other than U.S. dollars are translated in this Annual Report (as defined below) into U.S.dollars using exchange rates in effect at the date of the transactions. Unless otherwise 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 UnitedStates Food and Drug Administration (“FDA”) or other relevant regulatory authority and the term“commercial products” means products approved by the FDA that we commercialize or promotefrom time to time. Effective August 20, 2024, we effected a ratio change of the American Depositary Shares (ADSs) toour ordinary shares from the previous ratio of one (1) ADS representing four hundred (400) ordinaryshares to a new ratio of one (1) ADS representing ten thousand (10,000) ordinary shares. The ratiochange had the same effect as a one-for-twenty-five reverse ADS split. Unless otherwise indicated,ADSs and per ADS amounts in this Annual Report have been retroactively adjusted to reflect thechanges in ratio for all periods presented. 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” andelsewhere in this Annual Report on Form 20-F (the “Annual Report”) may include forward-lookingstatements. These statements involve known and unknown risks, uncertainties and other factors thatmay cause our actual results, performance or achievements to be materially different from any futureresults, performance or achievements expressed or implied by the forward-looking statements. Insomecases,you can identify forward-looking statements by terms,including“anticipates,”“believes,”“could,”“estimates,”“expects,”“intends,”“may,”“plans,”“potential,”“predicts,”“projects,” “should,” “will,” “would,” and similar expressions intended to identify forward-lookingstatements. Forward-looking statements reflect our current views with respect to future events and arebased on assumptions and subject to risks and uncertainties, many of which are beyond theCompany’s control and cannot be predicted or quantified. In addition, the section of this AnnualReportentitled,“Item 4.Information on the Company”,contains information obtained fromindependent industry and other sources that we may not have independently validated. You should notput undue reliance on any for