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Indivior PLC 2024年度报告

2025-03-03 美股财报 CS杨林
报告封面

☑ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the fiscal year endedDecember 31, 2024OR☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Indivior PLC 98-1204773(I.R.S. Employer Identification No.) Securities Registered pursuant to Section 12(b)of the Act: Securities registered pursuant to section 12(g) of the Act: None Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes☐No☑ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 duringthe preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirementsfor the past 90 days. Yes☑No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 ofRegulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).Yes☑No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or anemerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and "emerging growth company" inRule 12b-2 of the Exchange Act. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new orrevised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal controlover financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issuedits audit report.☑ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filingreflect the correction of an error to previously issued financial statements.☐ Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation receivedby any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes☐No☑ The aggregate market value of the voting and non-voting common equity held by non-affiliates at June 28, 2024 was approximately $2.15billion based on theNasdaq closing price for such shares on that date. For purposes of this calculation, the registrant has assumed that all of its directors and executive officersare affiliates. As of March 1, 2025, the number of outstanding ordinary shares was124,655,858. DOCUMENTS INCORPORATED BY REFERENCE None. TABLE OF CONTENTS GLOSSARY Aelis means Aelis Farma, a French company from whom we obtained an exclusive option for AEF0117, a synthetic CB1specific signaling inhibitor designed to treat cannabis-related disorders. AGM means Annual General Meeting ANDA means an additional new drug application filed with the FDA. AUD means alcohol use disorder. BARDA meansthe U.S. Biomedical Advanced Research and Development Authority. BMAT means buprenorphine-medically assisted treatment, the process to treat OUD patients treated with Buprenorphine(as opposed to methadone). CHMP means the Committee for Medicinal Products for Human Use, which is the relevant scientific committee in mostcases with which one files marketing authorization applications under the EMA. CIA refers to the Corporate Integrity Agreement which Indivior Inc. entered into in July 2020 with HHS-OIG. The five-yearCIA requires, among other things, that Indivior Inc. implement measures designed to ensure compliance with the statutes,regulations, and written directives of U.S. Medicare, U.S. Medicaid, and all other U.S. federal healthcare programs, as well aswith the statutes, regulations, and written directives of the U.S. Food and Drug Administration. CJS means criminal justice system. CMO means a contract manufacturing organization. CMS means the Centers for Medicare and Medicaid Services. CNS means central nervous system. Companies Act mean the U.K. Companies Act 2006 as amended, and the regulations made thereunder, which is theprincipal legislation under which we operate, and under which our ordinary share capital has been created. Compliance Measures means certain compliance measures set forth in Section I of Addendum A to the ResolutionAgreement which is filed as Exhibit 10.2 hereto