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INDIVIOR PLC

For the period ended Sep 30, 2025. Filed Oct 30, 2025.

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About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2025 · Filed Oct 30, 2025

INDV$36.28+2.6%Stored close · as of Nov 2, 2026

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Item 1. Unaudited Financial Statements

Index to Unaudited Condensed Consolidated Financial Statements

Condensed Consolidated Statements of Operations3
Condensed Consolidated Statements of Comprehensive Income (Loss)4
Condensed Consolidated Balance Sheets5
Condensed Consolidated Statements of Stockholders' Deficit6
Condensed Consolidated Statements of Cash Flow8
Notes to Condensed Consolidated Financial Statements9

Condensed Consolidated Statements of Operations

Three Months Ended September 30,Nine Months Ended September 30,
2025202420252024
Net revenue$314$307$881$889
Cost of sales8366179183
Gross profit230241702707
Operating expenses:
Selling, general and administrative155142445437
Research and development33227676
Acquired in-process research and development—1—1
Litigation settlement—361196
Other operating (income) expense, net(1)4(1)4
Total operating expenses187206521715
Operating income (loss)4335181(8)
Other (income) and expenses:
Interest (income)1(6)(5)(16)(18)
Interest expense112113928
Income (loss) before income taxes3730158(18)
Income tax expense (benefit)1(5)850(4)
Net income (loss)$42$22$108$(14)
1 Sign convention modified beginning in Q2 2025 (for all periods presented)
Earnings (loss) per share
Basic$0.34$0.16$0.87$(0.11)
Diluted$0.33$0.16$0.85$(0.11)
Shares used in computing earnings (loss) per share
Basic125132125134
Diluted129133127134

Condensed Consolidated Statements of Comprehensive Income (Loss)

(Amounts in millions)

Three Months Ended September 30,Nine Months Ended September 30,
2025202420252024
Net income (loss)$42$22$108$(14)
Other comprehensive income, net of tax
Foreign currency translation—735
Other comprehensive income—735
Total comprehensive income (loss)$43$29$111$(9)

Condensed Consolidated Balance Sheets

September 30, 2025December 31, 2024
Assets
Current assets
Cash and cash equivalents$445$319
Short-term investments—1
Accounts receivable, net of allowances of $2 (2025) and $3 (2024)259254
Inventories155167
Prepaid expenses3031
Current tax receivable1333
Other current assets1921
Total current assets922827
Long-term investments2827
Property, plant and equipment, net124100
Operating lease right of use assets, net3039
Goodwill and other intangible assets, net26
Deferred tax assets285277
Other noncurrent assets2739
Total assets$1,416$1,316
Liabilities and shareholders' deficit
Current liabilities
Accrued rebates and product returns$613$562
Accounts payable and accrued expenses215216
Accrued litigation settlement expenses, current10699
Current portion of long-term debt1818
Operating lease liabilities, current1010
Income taxes payable47
Other current liabilities—11
Total current liabilities965924
Long-term debt, less current portion304315
Accrued litigation settlement expenses, noncurrent300365
Operating lease liabilities, noncurrent2432
Other noncurrent liabilities3018
Total liabilities$1,623$1,652
Commitments and contingencies (Note 12)
Shareholders' deficit
Common stock, par value $0.50 per shareIssued shares: 125 (2025) and 125 (2024)6262
Additional paid-in capital10990
Share repurchase commitment—(10)
Accumulated other comprehensive loss(32)(36)
Accumulated deficit(346)(443)
Total shareholders' deficit(207)(337)
Total liabilities and shareholders' deficit$1,416$1,316

Condensed Consolidated Statements of Stockholders’ Deficit

Common Stock
SharesAmountAdditional paid-in capitalShare repurchase commitmentAccumulated other comprehensive lossAccumulated deficitTotal shareholders’ equity (deficit)
Balance, January 1, 2025125$62$90$(10)$(36)$(443)$(337)
Net income—————4747
Other comprehensive income————1—1
Common stock issued1—————1
Common stock repurchased and canceled(1)————(10)(11)
Share-based compensation——6———6
Share repurchase liability movement, net———10——10
Settlement of tax on equity awards——(3)———(3)
Balance, March 31, 20251256293—(35)(406)(285)
Net income—————1818
Other comprehensive income————2—2
Share-based compensation——8———8
Balance, June 30, 202512562101—(33)(388)(257)
Net income—————4242
Common stock issued——1———1
Share-based compensation——6———6
Balance, September 30, 2025125$62$109$—$(32)$(346)$(207)

Condensed Consolidated Statements of Stockholders’ Deficit

Common Stock
SharesAmountAdditional paid-in capitalShare repurchase commitmentAccumulated other comprehensive lossAccumulated deficitTotal shareholders’ equity (deficit)
Balance, January 1, 2024137$68$88$(23)$(30)$(288)$(184)
Net income—————6161
Other comprehensive loss————(3)—(3)
Common stock issued111———2
Common stock repurchased and canceled(2)(1)———(35)(36)
Share-based compensation——6———6
Share repurchase liability movement, net———14——14
Settlement of tax on equity awards——(20)———(20)
Other——(1)———(1)
Balance, March 31, 20241366874(9)(32)(262)(161)
Net loss—————(97)(97)
Common stock repurchased and canceled(2)(1)———(33)(34)
Share-based compensation——6———6
Share repurchase liability movement, net———5——5
Balance, June 30, 20241346780(4)(32)(393)(281)
Net income—————2222
Other comprehensive income————7—7
Common stock issued——1———1
Common stock repurchased and canceled(5)(2)———(50)(52)
Share-based compensation——6———6
Share repurchase liability movement, net———(12)——(12)
Balance, September 30, 20241306588(16)(24)(421)(310)

Condensed Consolidated Statements of Cash Flows

(Amounts in millions)

Nine Months Ended September 30,
20252024
Cash flows from operating activities:
Net income (loss)$108$(14)
Adjustments to reconcile net income (loss) to net cash from operating activities:
Depreciation and amortization811
Amortization of right-of-use assets78
Share-based compensation expense2118
Impairment of tangible and intangible assets168
Unrealized loss on equity investments17
Deferred income taxes(8)(30)
Acquired in-process research and development—1
Impact from foreign exchange movements(2)3
Other adjustments, net2—
Change in operating assets and liabilities:
Accounts receivable(3)3
Current inventories16(41)
Other current and noncurrent assets38389
Accrued legal and settlement expenses(58)(382)
Other current and noncurrent liabilities4971
Net cash provided by operating activities19453
Cash flows from investing activities:
Purchases of property and equipment(42)(13)
Purchases of in-process research and development and intangible assets(1)(1)
Purchases of investments in debt securities(14)(14)
Sales and maturities of debt securities1488
Net cash (used in) provided by investing activities(42)61
Cash flows from financing activities:
Proceeds from the issuance of common stock23
Cash paid for repurchases of common stock(11)(123)
Repayments of debt(12)(2)
Settlement of tax on equity awards(3)(20)
Net cash used in financing activities(25)(142)
Net increase (decrease) in cash and cash equivalents128(28)
Exchange differences(1)(1)
Cash and cash equivalents at beginning of period319316
Cash and cash equivalents at end of period$445$288
  1. Business Overview, Basis of Presentation, and Recently Issued Accounting Standards

Business Overview

Indivior PLC and its subsidiaries (together, "Indivior" or the "Company") is a pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). The Company's vision is that all patients will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a human crisis to a recognized and treated chronic disease. Building on its portfolio of OUD treatments, Indivior's product candidate pipeline is designed to extend its heritage in this category.

Basis of Consolidation

The accompanying unaudited interim Condensed Consolidated Financial Statements and related notes should be read in conjunction with the audited Consolidated Financial Statements of Indivior PLC and its subsidiaries and related notes as contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. The unaudited interim financial statements include all adjustments (consisting only of normal recurring adjustments) and accruals necessary in the judgment of management for a fair statement of the results for the periods presented.

The accounting policies of the Company are consistent with those disclosed in"Item 1. Financial Statements - Note 2. Summary of Significant Accounting Policies"of our Annual Report on Form 10-K for the year ended December 31, 2024.

Columns and rows within tables may not add due to rounding. Percentages and per share data have been calculated using actual, non-rounded figures.

Use of Estimates and Judgments

The preparation of Condensed Consolidated Financial Statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported. Significant estimates are used in determining items such as accruals for returns, incentives and rebates, certain accrued expenses, acquisitions, and ongoing litigation. Actual results may differ from those estimates.

Recently Adopted Accounting Standards

No new accounting standards were adopted during the nine months ended September 30, 2025.

Recently Issued Accounting Standards Not Yet Adopted

ASU 2024-03: Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40)—Disaggregation of Income Statement Expenses (as clarified by ASU 2025-01) was issued in November 2024, requires disclosure of specified information about certain costs and expenses in the notes to the financial statements and is required to be applied by the Company for fiscal periods beginning after December 15, 2027. As this accounting standard only impacts disclosures, it is not expected to have a material impact on the Company’s financial statements.

ASU 2025-05: Measurement of Credit Losses for Accounts Receivable and Contract Assets Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets was issued in July 2025 and allows entities to elect a practical expedient that assumes that the current conditions as of the balance sheet date do not change for the remaining life of the asset. ASU No. 2025-05 is effective for annual and interim periods beginning after December 15, 2025, is to be applied on a prospective basis and allows for early adoption. Adoption is not expected to have a material impact on the Company's financial statements.

ASU No. 2025-06, Intangibles-Goodwill and Other-Internal Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software was issued in September 2025 and removes all references to software development project stages. Software capitalization will begin when management has authorized and committed to funding the software project and when it is probable that the project will be completed and the software will be used to perform the function intended. ASU 2025-05 is effective for interim and annual periods beginning after December 15, 2027. The guidance may be applied on a prospective basis, a modified transition approach or a retrospective transition approach and allows for early adoption. Adoption is not expected to have a material impact on the Company's financial statements.

New Legislation

In July 2025, legislation commonly referred to as the One Big Beautiful Bill Act (the “OBBBA”) was enacted, introducing amendments to U.S. tax laws with various effective dates from 2025 to 2027, primarily impacting companies domiciled in the U.S. The Company evaluated the implications of these tax law changes and does not anticipate material impacts.

  1. Segment, Geographic and Other Revenue Information

The Company operates in a single operating and reportable segment for all periods presented and the CEO has been identified as the chief operating decision maker (“CODM”). The CODM uses income from operations to measure the profitability of the segment. These amounts are reported on the Condensed Consolidated Statements of Operations. The measure of segment assets is reported on the Condensed Consolidated Balance Sheets as total consolidated assets.

The financial data provided to the CODM is as follows:

Three Months Ended September 30,Nine Months Ended September 30,
2025202420252024
US:
SUBLOCADE*$203$177$561$524
Sublingual & other5161157188
OPVEE1815815
PERSERIS2681931
Total U.S.267261745757
Rest of World4746137132
Net revenue314307881889
Cost of sales8366179183
Gross profit230241702707
Operating expenses:
Selling and marketing6255209188
General and administrative9487236250
Total selling, general and administrative155142445437
Research and development33227676
Acquired in-process research and development—1—1
Litigation settlement—361196
Other operating expense (income), net(1)4(1)4
Total operating expenses187206521715
Operating income (loss)4335181(8)
Other (income) and expenses:
Interest (income)(6)(5)(16)(18)
Interest expense12113928
Income (loss) before income taxes3730158(18)
Income tax expense (benefit)(5)850(4)
Net income (loss)$42$22$108$(14)
*Total SUBLOCADE net revenue$219$191$604$562
Depreciation and amortization$2$4$8$11
Share-based compensation expense$6$6$21$18

1 Discontinued sales and marketing support for OPVEE during the third quarter of 2025.

2 Marketing and promotion activities for PERSERIS were discontinued in July 2024.

Significant segment expenses within net income (loss) include cost of sales, selling and marketing, general and administrative, research and development, and litigation settlement at the consolidated level. Other segment items within net income (loss) include acquired in-process research and development, other operating expense (income), net, interest (income), interest expense, and income tax expense (benefit). Our CODM is also regularly provided depreciation and amortization and share-based compensation expense information, both of which are presented above and are recorded within cost of sales and selling, general and administrative expenses.

Revenue recognized from performance obligations satisfied in previous periods was $15 million and $60 million in the three and nine months ended September 30, 2025 and $5 million and $28 million during the three and nine months ended September 30, 2024, respectively.

  1. Income Tax

Indivior is subject to taxation in several different jurisdictions. The Company's tax provision for each period presented was calculated using a forecasted annual tax rate, adjusted for discrete items occurring during the applicable period to arrive at an effective tax rate. The effective income tax rates for the relevant periods are calculated as follows:

Three Months Ended September 30,Nine Months Ended September 30,
2025202420252024
Total income (loss) before income taxes$37$30$158$(18)
Total income tax expense (benefit)$(5)$8$50$(4)
Total effective tax rate(14)%27%32%21%

Our income tax rate for the three months ended September 30, 2025 differs from the U.K. Federal statutory rate of 25%, primarily due to U.K. innovation deductions and a reduction in Pillar II top-up tax expense, offset by disallowed expenses.

Our income tax rate for the nine months ended September 30, 2025 differs from the U.K. Federal statutory rate of 25%, primarily due to expense recognized for a U.K. HMRC settlement which became probable during the second quarter of 2025, a valuation allowance against corporate interest limitation carryforwards, share-based compensation shortfall tax expense and disallowed expenses, partially offset by U.K. innovation deductions and intragroup financing transactions. The HMRC settlement relates to aspects of prior years' intercompany financing arrangements and is not expected to impact our future tax rates.

Our income tax rate for the three months ended September 30, 2024 differs from the U.K. Federal statutory rate of 25%, primarily due to disallowed expenses, offset by a reduction to a valuation allowance against corporate interest limitation carryforwards, excess share-based compensation benefit and intragroup financing transaction benefits.

Our income tax rate for the nine months ended September 30, 2024 differs from the U.K. Federal statutory rate of 25%, due primarily to disallowed expenses, offset by intragroup financing transaction benefits and excess share-based compensation benefits.

We are subject to income taxation in many jurisdictions. Unrecognized tax benefits reflect the differences between tax positions we have taken or expect to take on income tax returns and the amounts recognized in our financial statements. Resolution of the related tax positions with the relevant tax authorities may take many years to complete, and such timing is not entirely within our control.

Changes in unrecognized tax benefits are summarized as follows for the nine months ended September 30, 2025.

(In millions)
Balance at December 31, 2024$4
Additions for tax positions of prior years32
Balance at September 30, 2025$36

During the three months ended September 30, 2025, no new unrecognized tax positions were added. During the nine months ended September 30, 2025, we recorded $32 million in tax expense related to a settlement with U.K. HMRC which became probable during the second quarter of 2025, in relation to aspects of a finance structure in place from 2019 through May 2024. No other material changes to the Company's unrecognized tax benefit have occurred since December 31, 2024.

During the three and nine months ended September 30, 2025, the Company accrued and expensed interest of $1 million and $6 million, respectively.

The total amount of unrecognized tax benefits relating to the Company’s tax positions is subject to change based on future events including, but not limited to, the settlement of ongoing tax audits and assessments and the expiration of applicable statutes of limitations.

The Company is not subject to U.K. examinations by tax authorities for fiscal years before 2019 and U.S. federal income tax examinations by tax authorities for fiscal years before 2021. U.K. and U.S. state and local audits covering 2018 - 2022 are ongoing. An estimate of reasonably possible additional tax liabilities and interest that could arise on resolution of these examinations, including the impact from later periods, is in the range ofnil to $12 million.

  1. Inventories

Inventories are comprised of:

September 30, 2025December 31, 2024
Raw materials and consumables$32$33
Work in progress4351
Finished goods8294
Total Inventories, net$157$178

Inventory expected to be sold more than one year from the balance sheet date is classified as noncurrent inventory and recorded in other noncurrent assets on the condensed consolidated balance sheets. At September 30, 2025 and December 31, 2024, the noncurrent portion of inventory was $1 million and $10 million, respectively, and consisted primarily of raw materials and consumables (see Note 14. Revision of Previously Issued Financial Statements).

Cumulative inventory write-downs reflected in the carrying amounts above at September 30, 2025 and December 31, 2024 were $41 million and $26 million, respectively. In the quarter ended September 30, 2025, $16 million of inventory write-downs related to the discontinuation of sales and marketing support for OPVEE were recorded within cost of sales. See Note 13. Restructuring for additional details.

  1. Property, Plant and Equipment, Net

A summary of property, plant and equipment is as follows:

September 30, 2025December 31, 2024
Land and buildings$106$76
Plant and equipment7776
Construction in progress4738
Gross property, plant and equipment230190
Less: Accumulated depreciation(106)(90)
Total property, plant and equipment, net$124$100

The Company capitalizes interest expense, if material, as part of the cost of construction of property, plant and equipment. Interest expense capitalized was $2 million and $4 million in the three and nine months ended September 30, 2025 andnil and $1 million in the three and nine months ended September 30, 2024, respectively.

Property, plant and equipment impairment charges related to the corporate initiative transition of $11 million were recognized in research and development expenses in the three and nine months ended September 30, 2025. See Note 13. Restructuring for additional details.

Capital expenditures of $1 million and $2 million were included in accounts payable and accrued expenses at September 30, 2025 and September 30, 2024, respectively.

  1. Accounts Payable and Accrued Expenses
September 30, 2025December 31, 2024
Accounts payable$41$63
Accrued employee-related obligations7960
Accrued indirect tax and government fees2723
Accruals for third-party services6064
Accrued other expenses86
Total accounts payable and accrued expenses$215$216
  1. Accrued Litigation Settlement Expenses
September 30, 2025December 31, 2024
CurrentNon currentTotalCurrentNon currentTotal
Accrued litigation settlement expenses
DOJ-related$51$247$299$52$296$348
Antitrust claims20—2024—24
Opioid litigation275380156176
Other8—88816
Total accrued litigation settlement expenses$106$300$406$99$365$464

DOJ-related

In July 2020, the Company settled criminal and civil liability with the U.S. Department of Justice (DOJ), the U.S. Federal Trade Commission (FTC), and U.S. state attorneys general. A scheduled payment of $52 million was made during the nine months ended September 30, 2025 with respect to this matter.

Opioid litigation

The accrual of $80 million at September 30, 2025 reflects the present value of the agreed amount in a settlement covering certain opioid litigation (including cases in the Opioid MDL). The provision is measured using a risk-free rate.

Antitrust claims

An installment of $5 million was paid in the nine months ended September 30, 2025 in relation to antitrust litigation. The remaining accrual of $20 million at September 30, 2025 reflects the net present value (NPV) at the risk-free rate of the amounts to be paid in 2025. This final settlement resolved all of the Company’s remaining legacy antitrust litigation.

See Note 12. Commitments and Contingencies for additional information on legal matters.

  1. Debt

The Company has a note purchase agreement with an original principal amount of $350 million and a committed revolving credit facility of $50 million, both of which mature in November 2030. None of the$50 million revolving credit facility has been drawn upon.

The outstanding balance of the note purchase agreement of $337 million and $350 million as of September 30, 2025 and December 31, 2024, respectively, is secured by substantially all of the assets of the Company's subsidiaries, primarily in the form of guarantees issued by respective subsidiaries. Interest expense was $9 million and $26 million for the three and nine months ended September 30, 2025 and $7 million and $20 million for the three and nine months ended September 30, 2024, respectively.

The Company was in comp liance with all debt covenants at September 30, 2025.

  1. Financial Instruments and Fair Value Measurements

Financial instruments include cash and cash equivalents, accounts receivable, accounts payable, debt, investments in corporate debt securities and investments in equity securities. The carrying value of these financial instruments, excluding debt instruments and the Company’s investments in corporate debt and equity securities, approximates fair value because of the short-term nature of these instruments.

The following three levels of inputs are used to measure fair value:

Level 1 — Quoted prices in active markets for identical assets and liabilities.

Level 2 — Significant other observable inputs.

Level 3 — Significant unobservable inputs.

The Company’s only financial instruments which are measured at fair value on a recurring basis are equity securities. The fair value of equity securities is based on quoted market prices (Level 1 inputs) on the measurement date. The fair value of equity securities at September 30, 2025 and December 31, 2024 wasnil and $1 million, respectively.

The fair value of corporate debt securities at September 30, 2025 and December 31, 2024 was $28 million and $27 million, respectively. The fair value of corporate debt securities held at amortized cost was calculated based on quoted market prices which would be classified as Level 1 in the fair value hierarchy above. At September 30, 2025, the Company's debt securities were held by a separate cell of an insurance company as part of an agreement to fund insurance coverage. These debt securities are classified as long-term investments on the condensed consolidated balance sheets as access to the investments is subject to contractual restrictions, regardless of the underlying investment maturity.

The fair value of debt at September 30, 2025 and December 31, 2024 was $337 million and $350 million, respectively. The fair value of debt is based on unobservable inputs and is classified as Level 3 in the hierarchy above. Given the short period since the initial issuance date and no significant changes in the economic environment or bond yields, the carrying value reasonably reflects fair value at September 30, 2025.

  1. Earnings Per Share

The following table summarizes the calculation of basic and diluted earnings (loss) per share for each period:

Three Months Ended September 30,Nine Months Ended September 30,
2025202420252024
Net income (loss)$42$22$108$(14)
Basic weighted-average shares outstanding125132125134
Effect of potentially dilutive securities:
Restricted stock awards14—2—
Diluted weighted-average shares outstanding129133127134
Basic earnings (loss) per share0.340.160.87(0.11)
Diluted earnings (loss) per share0.330.160.85(0.11)

1 The potential shares excluded from the diluted earnings per share computation because of the antidilutive impact werenil in the three and nine months ended September 30, 2025 andnil and 1 million for the three and nine months ended September 30, 2024, respectively.

The weighted average number of shares is adjusted for the number of shares granted to the extent market conditions have been met at the balance sheet date and determined using the treasury stock method.

Conditional awards of 5 million shares were granted in the nine months ended September 30, 2025 and 2 million in the nine months ended September 30, 2024 under the Company’s Long-Term Incentive Plan, respectively.

  1. Share-Based Payments

The Company operates three equity-settled executive and employee share plans. For share-based payment awards, the fair value at the grant date is calculated using appropriate pricing models. The programs and related accounting are described in "Item 8. Financial Statements—Note 15. Share-Based Payments” of our Annual Report on Form 10-K for the year ended December 31, 2024.

Three Months Ended September 30,Nine Months Ended September 30,
2025202420252024
Compensation expense related to share-based payments$6$6$21$18

Indivior Long-Term Incentive Plan (LTIP)

A summary of the service-based restricted share awards and performance-based share awards activity under the LTIP for the nine months ended September 30, 2025 is presented below (values in thousands):

Outstanding Service-Based Restricted Share AwardsOutstanding Performance-Based Share Awards
Shares at December 31, 20241,0364,717
Granted2,3493,011
Issued(275)(286)
Canceled/forfeited/adjusted(625)(2,079)
Shares at September 30, 20252,4845,364

The weighted average fair value per share of the service-based restricted share awards granted was $10.23 for the nine months ended September 30, 2025, based on the fair market value at the date of grant. The total fair value of restricted share awards issued was $5 million for the nine months ended September 30, 2025.

The weighted average fair value per share of the performance-based share awards granted per share was $8.79 for the nine months ended September 30, 2025, calculated using the weighted average fair market value for each of the component goals at the date of grant. The total fair value of performance-based share awards issued wasnil for the nine months ended September 30, 2025.

Total compensation cost for unvested awards not yet recognized at September 30, 2025 was $23 million and $26 million for service-based restricted share awards and performance-based restricted awards, respectively. We recognize compensation cost over the expected remaining weighted-average period of 2.2 years and 2.3 years for service-based restricted share awards and performance-based share awards, respectively.

Share Options

The Company didnot grant any share options in the nine months ended September 30, 2025. No share options were exercised in nine months ended September 30, 2025.

  1. Commitments and Contingencies

Legal Proceedings and Contingencies

The Company records accruals for loss contingencies associated with legal matters when it is probable that a liability will be incurred and the amount of the loss can be reasonably estimated. Certain ongoing legal proceedings or threats of legal proceedings to which the Company is a party, but in which the Company believes the possibility of an adverse impact is remote, are not discussed in this Note.

Civil Opioid Litigation

As previously disclosed, pursuant to mediation, the Company, the Plaintiffs' Executive Committee

(PEC), and an executive committee of state attorneys general reached settlement terms related to certain civil opioid litigation (discussed below), which would allow subdivisions, including those cities and counties that filed suit against Indivior as discussed below, to potentially sign on to the terms of a settlement. No states have indicated that they do not intend to opt in except the State of Maryland. Maryland could elect to join later in the process. The process for the subdivisions of the various states to elect whether to participate in the settlement will take time (the "opt-in process"). The Company separately executed a master settlement agreement with the Tribal Leadership Committee (TLC), which is now complete with all tribes signing off on settlement. Whether the settlements with the subdivisions or states will be finalized and the actions dismissed depends on sufficient participation in each agreement. The Company presently anticipates that the opt-in process will not be complete before the end of January 2026; however, there is no assurance that this will occur at that time. The Company has recorded a related provision of $80 million, reflecting the NPV of the agreed amount (See Note 7. Accrued Litigation Settlement Expenses).

The Company has been named as a defendant in more than 400 civil lawsuits alleging that manufacturers, distributors, and retailers of opioids engaged in a longstanding practice to market opioids as safe and effective for the treatment of long-term chronic pain to increase the market for opioids and their own market shares for opioids, or alleging individual personal injury claims. Most of these cases have been consolidated and are pending in a federal multi-district litigation in the U.S. District Court for the Northern District of Ohio. See In re National Prescription Opiate Litigation, MDL No. 2804 (N.D. Ohio) (the "Opioid MDL"). The mediation and potential settlement discussed above was designed to include subdivisions such as cities and counties and tribal nations. Nearly two-thirds of the cases in the Opioid MDL were filed by cities and counties. Cases brought by cities and counties outside of the MDL include, for example,35 actions pending in New York state court,9 writs filed in Pennsylvania state court, and actions brought in federal district courts in Florida and Georgia. Litigation against the Company in the Opioid MDL and the other federal courts is stayed. The New York state court has not yet entered a case management order. The Company has not yet been served with a complaint in any of the Pennsylvania state court matters. About one-third of the cases in the Opioid MDL were filed by private plaintiffs, most of whom assert claims relating to neonatal abstinence syndrome ("NAS"). The mediation and settlements discussed above would not resolve private plaintiff cases against the Company (whether they were filed in the MDL or not).

On May 23, 2024, the Consumer Protection Division of the Office of the Attorney General of Maryland served on Indivior Inc. an administrative subpoena related generally to opioid products marketed and sold in Maryland. Indivior Inc.'s response to the subpoena remains ongoing.

On October 28, 2024, Indivior Inc. was named as one of numerous defendants infive individual complaints involving claims related to NAS and filed in West Virginia state court, that were transferred to West Virginia's Mass Litigation Panel. See In re Opioid Litigation, No. 22-C-9000 NAS (W.V. Kanawha Cnty. Cir. Ct.) ("WV MLP Action"). The plaintiffs filed a notice of appeal in the West Virginia Supreme Court as to all defendants, including Indivior, on February 27, 2025. Briefing on this matter was completed in August. There has been no decision by the West Virginia Supreme Court.

As it relates to the private complaints and any subdivisions or states that do not opt in to the opt-in process, the Company believes it has meritorious defenses, and intends to vigorously defend itself in all actions that would not be resolved by the proposed settlement. Given the status and preliminary stage of litigation, no estimate of total possible loss for those matters can be made at this time.

Dental Allegations

The Company has been named as a defendant in numerous lawsuits alleging that SUBOXONE Film was defectively designed and caused dental injury, and that the Company failed to properly warn of the risks of such injuries. The plaintiffs generally seek compensatory damages, as well as punitive damages and attorneys’ fees and costs. Plaintiffs and potential plaintiffs related to these lawsuits generally can be grouped as follows:

As of October 29, 2025 Dental MDL Plaintiffs of over 1,900 cases naming over 22,500 plaintiffs have been consolidated in multi-district litigation in the Northern District of Ohio. See In Re Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation, MDL No. 3092 (N.D. Oh.) (the "Dental MDL").

Dental MDL Schedule A Plaintiffs: One complaint filed in the Dental MDL on June 14, 2024 attached a schedule of nearly 10,000 plaintiffs (the “Schedule A Plaintiffs”). The parties negotiated a tolling agreement for the Schedule A Plaintiffs that would permit plaintiffs’ counsel additional time to investigate issues such as whether any Indivior product was used before determining whether to file individual complaints to be coordinated with the Dental MDL. Plaintiffs have been dismissing Schedule A claimants pursuant to a mechanism provided by the court. As of October 29, 2025 the plaintiffs had reduced the number of Schedule A claimants to 8,035.

State Court Plaintiffs: One complaint has been filed in New Jersey state court, and the parties have agreed to toll the claims of more than 975 other individuals in Delaware, New Jersey, and Virginia. Complaints have not yet been filed on behalf of the tolled individuals.

Proposed class actions based on similar allegations as in the Dental MDL, but also relating to SUBOXONE Tablets, were filed in Quebec and British Columbia against various subsidiaries of the Company, among other defendants, in April 2024.

The Company has begun its evaluation of the claims, believes it has meritorious defenses, and intends to vigorously defend itself. Given the status and preliminary stage of litigation, no estimate of possible loss can be made at this time.

U.K. Shareholder Claims

On September 21, 2022, certain shareholders issued representative and multiparty claims against Indivior PLC in the High Court of Justice for the Business and Property Courts of England and Wales, King’s Bench Division. The claims made in both the representative and multiparty actions generally allege that Indivior PLC violated the U.K. Financial Services and Markets Act 2000 (“FSMA 2000”) by making false or misleading statements or material omissions in public disclosures, including the 2014 Demerger Prospectus, regarding an alleged product-hopping scheme regarding the switch from SUBOXONE Tablets to SUBOXONE Film. Indivior PLC filed an application to strike out the representative action, which ultimately was struck out by the High Court and affirmed on appeal. On August 8, 2025 those certain shareholders served their "Particulars of Claim" on Indivior PLC related to the multiparty action. On October 6, 2025, the Company served on those certain shareholders its Defence. The deadline for the certain shareholders to file their Reply to the Defence is November 17, 2025. The Company has begun its evaluation of the remaining claims, believes it has meritorious defenses, and intends to vigorously defend itself. Given the status and preliminary stage of the litigation, no estimate of possible loss can be made at this time.

U.S. Shareholder Claims

A class action lawsuit was filed against Indivior PLC, Mark Crossley (the former CEO of the Company), and Ryan Preblick (the CFO of the Company) on August 2, 2024, alleging violations of certain U.S. federal securities laws, and the lead plaintiff filed an amended complaint on December 5, 2024 which also named Richard Simkin (the former CCO of the Company) as a defendant. The defendants moved to dismiss. On September 15, 2025, the court granted the motion to dismiss. The defendants did not file an appeal by the deadline of October 15, 2025.

  1. Restructuring

On August 26, 2025, the Company announced major initiatives as part of Phase 1 of the Indivior Action Agenda — Generate Momentum. Related to these initiatives, in the three months ended

September 30, 2025, $35 million of corporate initiative transition costs were recognized, consisting of headcount reductions, impairment of real estate, and consulting, legal and tax expenses.

Additionally, during the third quarter, the Company discontinued the sales and marketing support for OPVEE. The Company recognized $37 million of costs in the three months ended September 30, 2025, including the write-down of inventory and intangible assets and expenses related to contract termination. No additional costs related to the costs in the table below are expected to be incurred.

Impairment charges, provisions, write-downs and other2025
Charged to Cost of sales:
OPVEE inventory write-down$16
OPVEE contract termination and related expenses16
OPVEE intangible asset impairment5
Sub-total: Cost of sales37
Charged to Research and development:
Corporate initiative transition costs - impairment of PPE, net11
Corporate initiative transition costs - severance, legal, consulting, and other2
Sub-total: Research and development13
Charged to Selling, general and administrative:
Corporate initiative transition costs - severance, legal, consulting, and other22
Sub-total: Selling, general and administrative22
Total charges$72

Prior to the third quarter, there were no obligations related to the costs shown in the table above. As of September 30, 2025, remaining obligations for these restructuring costs were $16 million for OPVEE contract termination and related expenses and $13 million for severance, legal, consulting, and other corporate initiative transition costs.

  1. Revision of Previously Issued Financial Statements

As previously disclosed in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, during the first quarter of 2025, the Company identified an error in the methodology used to accrue for Indivior's share of the annual U.S. fee imposed on drug manufacturers (the "Branded Fee"). This resulted in an overstatement of the Branded Fee accrual for the periods presented in the Company's Annual Report on Form 10-K for the year ended December 31, 2024.

The overstatement of the Branded Fee accrual did not materially impact the Company's previously issued financial statements for any of the prior quarters or the annual periods in which they occurred. However, in accordance with Staff Accounting Bulletin No. 108 of the Securities and Exchange Commission, the Company concluded that correcting the cumulative misstatement in the current period would be material to its results of operations for the quarter ended March 31, 2025. Accordingly, the Company has revised, or will revise in future filings as applicable, its previously issued Consolidated Financial Statements as of December 31, 2024 and 2023 and for the years ended December 31, 2024, 2023 and 2022 to correct this accrual overstatement. Additionally, the Company has revised, or will revise in future filings as applicable, its quarterly financial data for the three months ended March 31, June 30, September 30, and December 31, 2024. A summary of the corrections to the impacted financial statement line items is presented below. An adjustment to reclassify a portion of inventories as other noncurrent assets as of December 31, 2024 and 2023 has also been reflected below.

Consolidated Balance Sheets

As reportedAdjustmentRevised
December 31, 2024
Inventories$178$(10)$167
Current tax receivable34(1)33
Total current assets839(12)827
Deferred tax assets280(3)277
Other noncurrent assets291039
Total assets$1,319$(4)$1,316
Accounts payable and accrued expenses$232$(16)$216
Total current liabilities939(16)924
Total liabilities1,668(16)1,652
Accumulated deficit(454)12(443)
Total shareholders' deficit(348)12(337)
Total liabilities and shareholders' deficit$1,319$(4)$1,316
December 31, 2023
Inventories$135$(9)$126
Total current assets1,266(9)1,257
Deferred tax assets288(2)286
Other noncurrent assets28936
Total assets$1,760$(2)$1,758
Accounts payable and accrued expenses$204$(10)$195
Total current liabilities1,290(10)1,281
Total liabilities1,951(9)1,942
Accumulated deficit(295)7(288)
Total shareholders' deficit(191)7(184)
Total liabilities and shareholders' deficit$1,760$(2)$1,758

Consolidated Statements of Operations

As reportedAdjustmentRevised
Year ended December 31, 2024
Selling, general and administrative expenses$618$(6)$612
Total operating expenses, net925(6)919
Operating income32638
Income before income taxes14620
Income tax expense(11)(2)(13)
Net income$2$5$7
Earnings per Share
Basic$0.02$0.03$0.05
Diluted$0.02$0.03$0.05
Year ended December 31, 2023
Selling, general and administrative expenses$569$(4)$565
Total operating expenses, net1,076(4)1,072
Operating loss(156)4(152)
Loss before income taxes(149)4(145)
Income tax benefit20(1)19
Net loss$(129)$3$(126)
Loss per Share
Basic$(0.94)$0.02$(0.92)
Diluted$(0.94)$0.02$(0.92)
Year ended December 31, 2022
Selling, general and administrative expenses$469$(4)$466
Total operating expenses, net831(4)827
Operating loss(81)4(77)
Loss before income taxes(89)4(86)
Income tax benefit44(1)43
Net loss$(44)$3$(42)
Loss per Share
Basic$(0.32)$0.02$(0.30)
Diluted$(0.32)$0.02$(0.30)

The consolidated statements of comprehensive income (loss) and the consolidated statements of shareholders' deficit were also revised to reflect the net income (loss) noted above for the years ended December 31, 2024, 2023 and 2022.

Consolidated Statements of Cash Flows

As reportedAdjustmentRevised
December 31, 2024
Net income$2$5$7
Deferred income taxes617
Change in operating assets and liabilities:
Inventories(45)2(43)
Other current and noncurrent assets378(1)377
Other current and noncurrent liabilities14(6)8
Net cash provided by operating activities$36$—$36
December 31, 2023
Net loss$(129)$3$(126)
Deferred income taxes(65)1(64)
Change in operating assets and liabilities:
Inventories(15)9(6)
Other current and noncurrent assets(410)(9)(418)
Other current and noncurrent liabilities114(4)110
Net cash used in operating activities$(300)$—$(300)
December 31, 2022
Net loss$(44)$3$(42)
Deferred income taxes(105)1(104)
Change in operating assets and liabilities:
Other current and noncurrent liabilities(97)(4)(100)
Net cash used in operating activities$(4)$—$(4)

Revisions to unaudited selected quarterly financial data presented in our Annual Report on Form 10-K for the year ended December 31, 2024 are summarized as follow

As reportedAdjustmentRevised
Three months ended March 31, 2024
Selling, general and administrative expenses$145$(2)$143
Total operating expenses, net172(2)171
Operating income73275
Income before income taxes71273
Income tax expense(11)—(11)
Net income$60$1$61
Three months ended June 30, 2024
Selling, general and administrative expenses$153$(2)$152
Total operating expenses, net340(2)338
Operating loss(119)2(118)
Loss before income taxes(122)2(121)
Income tax benefit24—23
Net loss$(98)$1$(97)
Three months ended September 30, 2024
Selling, general and administrative expenses$144$(2)$142
Total operating expenses, net207(2)206
Operating income34235
Income before income taxes28230
Income tax expense(8)—(8)
Net income$21$1$22
Three months ended December 31, 2024
Selling, general and administrative expenses$177$(2)$175
Total operating expenses, net206(2)205
Operating income44246
Income before income taxes36238
Income tax expense(16)—(17)
Net income$20$1$21
  1. Subsequent Events

In October 2025, the Company initiated the optimization of the ROW business with plans to exit several non-U.S. markets, including the U.K., Ireland, Sweden, Israel, Finland and Italy. The Company will continue to own and operate its Fine Chemicals Plant in Hull, U.K. and will also continue to sell product and maintain operations in Canada, Australia and France, and sell product in Germany.

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