indv-20250331

SEC Form 10-Q filed by Indivior PLC

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2025

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission file number: 001-37835

Indivior PLC

(Exact name of registrant as specified in its charter)


England and Wales		98-1204773
State or other jurisdiction of incorporation or organization		(I.R.S. Employer Identification No.)
	10710 Midlothian Turnpike Suite 125 North Chesterfield, VA 23235
	(address of principal executive offices)(zip code)
	Registrant's telephone number, including area code: (804) 379-1040

Securities Registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Ordinary shares, $0.50 nominal value per share

INDV

The Nasdaq Stock Market LLC

INDV

London Stock Exchange

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 during the 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 requirements for 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 of Regulation 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 an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and "emerging growth company" in Rule 12b-2 of the Exchange Act.

☑

Large accelerated filer

☐

Accelerated filer

☐

Non-accelerated filer

☐

Smaller reporting company

☐

Emerging growth company

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 or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☑

As of May 1, 2025, the number of outstanding ordinary shares was 124,769,533.

Table of Contents


Table of Contents			1
PART I - FINANCIAL INFORMATION			2
Item 1. Unaudited Financial Statements.			2
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.			21
Item 3. Quantitative and Qualitative Disclosures About Market Risk.			27
Item 4. Controls and Procedures			27
PART II - OTHER INFORMATION			28
Item 1. Legal Proceedings.			28
Item 1A. Risk Factors.			28
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.			29
Item 3. Defaults Upon Senior Securities.			29
Item 4. Mine Safety Disclosures.			29
Item 5. Other Information.			29
Item 6. Exhibits.			30
SIGNATURES			31

Important cautionary note regarding forward-looking statements

Certain statements contained herein, as well as in other filings we make with the SEC and other written and oral information we release, regarding our performance or other events or developments in the future constitute “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among other things, express and implied statements pertaining to the Company’s financial guidance including revenue, gross margin and operating margin for 2025 and its medium- and long-term growth outlook; capital expenditures; and statements containing the words "believe", "anticipate", "plan", "expect", "intend", "estimate", "forecast," "strategy", "target", "guidance", "outlook", "potential", "project", "priority," "may", "will", "should", "would", "could", "can", "outlook," the negatives thereof, and variations thereon and similar expressions. By their nature, forward-looking statements involve risks and uncertainties as they relate to events or circumstances that may or may not occur in the future.

Actual results may differ materially from those expressed or implied in such statements because they relate to future events. For information about some of the risks and important factors that could affect our future results and financial condition, see the discussion of “Risk Factors” in our Annual Report on Form 10-K filed March 3, 2025, Part II Item 1A herein, and our other filings with the U.S. Securities and Exchange Commission.

We have based the forward-looking statements in this report on our current expectations and beliefs concerning future events. Forward-looking statements contained in this report speak only as of the day they are made and, except as required by law, we undertake no obligation to update or revise any forward-looking statement, whether due to new information, future developments or otherwise.

PART I - FINANCIAL INFORMATION

Item 1. Unaudited Financial Statements.

Index to Unaudited Condensed Consolidated Financial Statements


Condensed Consolidated Statements of Operations			3
Condensed Consolidated Statements of Comprehensive Income			3
Condensed Consolidated Balance Sheets			4
Condensed Consolidated Statements of Stockholders' Deficit			5
Condensed Consolidated Statements of Cash Flow			6
Notes to Condensed Consolidated Financial Statements			7

Indivior PLC

Condensed Consolidated Statements of Operations and Comprehensive Income

(Amounts in millions, except per share data)

(Unaudited)


	Three Months Ended March 31,
	2025		2024
Net revenue	$	266	$	284
Cost of sales	44		38
Gross profit	221		246

Operating expenses:
Selling, general and administrative	132		143
Research and development	22		28

Litigation settlement	1		—


Total operating expenses	156		171

Operating income	66		75

Other income and expenses:
Interest income	4		7
Interest expense	(12)		(9)
Income before income taxes	59		73

Income tax expense	(11)		(11)

Net income	$	47	$	61

Earnings per share
Basic	$	0.38	$	0.45
Diluted	$	0.38	$	0.45

Shares used in computing earnings per share
Basic	124		136
Diluted	125		137


	Three Months Ended March 31,
	2025		2024
Net income	$	47	$	61
Other comprehensive income (loss), net of tax
Foreign currency translation	1		(3)
Other comprehensive income (loss)	1		(3)
Total comprehensive income	$	49	$	59

See Notes to Condensed Consolidated Financial Statements.

Indivior PLC

Condensed Consolidated Balance Sheets

(Amounts in millions, except per share data)

(Unaudited)


	March 31, 2025		December 31, 2024
Assets
Current assets
Cash and cash equivalents	$	372	$	319
Short-term investments	1		1
Accounts receivable, net of allowances of $2 (2025) and $3 (2024)	243		254
Inventories	163		167
Prepaid expenses	56		31

Current tax receivable	29		33
Other current assets	20		21
Total current assets	883		827
Long-term investments	27		27
Property, plant and equipment, net	104		100
Operating lease right of use assets, net	37		39
Goodwill and other intangible assets, net	7		6
Deferred tax assets	279		277

Other non-current assets	39		39
Total assets	$	1,375	$	1,316
Liabilities and shareholders' deficit
Current liabilities
Accrued rebates and product returns	$	675	$	562


Accounts payable and accrued expenses	183		216
Accrued litigation settlement expenses, current	105		99
Current portion of long-term debt	18		18
Operating lease liabilities, current	11		10
Income taxes payable	12		7
Other current liabilities	3		11
Total current liabilities	1,005		924

Long-term debt, less current portion	311		315
Accrued litigation settlement expenses, non-current	297		365
Operating lease liabilities, non-current	30		32
Other non-current liabilities	17		18
Total liabilities	1,660		1,652
Commitments and contingencies (Note 12)

Shareholders' deficit
Common stock, par value $0.50 per share Issued shares: 125 (2025) and 125 (2024)	62		62
Additional paid-in capital	93		90
Share repurchase commitment	—		(10)
Accumulated other comprehensive loss	(35)		(36)
Accumulated deficit	(406)		(443)
Total shareholders' deficit	(285)		(337)
Total liabilities and shareholders' deficit	$	1,375	$	1,316

See Notes to Condensed Consolidated Financial Statements.

Indivior PLC

Condensed Consolidated Statements of Stockholders’ Deficit

(Amounts in millions, except per share data)

(Unaudited)


	Common Stock
	Shares	Amount	Additional paid-in capital	Share repurchase commitment	Accumulated other comprehensive loss	Accumulated deficit	Total shareholders’ equity (deficit)
Balance, January 1, 2024	137	68	88	(23)	(30)	(288)	(184)
Net income	—	—	—	—	—	61	61
Other comprehensive loss	—	—	—	—	(3)	—	(3)
Common stock issued	1	1	1	—	—	—	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, 2024	136	68	74	(9)	(32)	(262)	(161)


	Common Stock
	Shares	Amount	Additional paid-in capital	Share repurchase commitment	Accumulated other comprehensive loss	Accumulated deficit	Total shareholders’ equity (deficit)
Balance, January 1, 2025	125	62	90	(10)	(36)	(443)	(337)
Net income	—	—	—	—	—	47	47
Other comprehensive income	—	—	—	—	1	—	1
Common stock issued	1	—	—	—	—	—	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, 2025	125	62	93	—	(35)	(406)	(285)

See Notes to Condensed Consolidated Financial Statements.

Indivior PLC

Condensed Consolidated Statements of Cash Flows

(Amounts in millions)

(Unaudited)


	Three Months Ended March 31,
	2025		2024
Cash flows from operating activities:
Net income	$	47	$	61
Adjustments to reconcile net income to net cash from operating activities:
Depreciation and amortization	5		5
Share-based compensation expense	6		6
Impairment of tangible and intangible assets	—		1

Deferred income taxes	(2)		3

Impact from foreign exchange movements	(1)		(1)
Other adjustments, net	1		1
Change in operating assets and liabilities:
Accounts receivable	11		4
Inventories	5		(27)

Other current and non-current assets	(18)		396
Accrued legal and settlement expenses	(62)		(486)
Other current and non-current liabilities	81		—
Net cash provided by (used in) operating activities	75		(37)
Cash flows from investing activities:
Purchases of property and equipment	(5)		(2)
Purchases of in-process research and development and intangible assets	—		(1)

Purchases of investments in debt securities	(5)		(4)
Sales and maturities of debt securities	6		31

Net cash (used in) provided by investing activities	(5)		25
Cash flows from financing activities:
Proceeds from the issuance of common stock	1		2
Cash paid for repurchases of common stock	(11)		(36)

Repayments of debt	(4)		(1)
Other	—		(1)

Settlement of tax on equity awards	(3)		(20)
Net cash used in financing activities	(17)		(56)
Net increase (decrease) in cash and cash equivalents	53		(68)

Cash and cash equivalents at beginning of period	319		316
Cash and cash equivalents at end of period	$	372	$	248

See Notes to Condensed Consolidated Financial Statements.

Indivior PLC

Notes to the Condensed Consolidated Financial Statements

(Dollars and shares in millions)

(Unaudited)

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 global pharmaceutical company working to help change patients’ lives by pioneering life-transforming treatment for addiction, including SUBLOCADE (buprenorphine extended-release) injection for subcutaneous use, a long-acting injectable (LAI) for opioid use disorder and OPVEE (Nalmefene) nasal spray for opioid overdose recovery.

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 Issued Accounting Standards

There were no material new accounting standards issued or adopted in the first quarter of 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

This update requires disclosure in the notes to the financial statements of specified information about certain costs and expenses and is required to be effective for the Company for fiscal periods beginning after December 15, 2026. As this accounting standard only impacts disclosures, it will not impact the Company’s Consolidated Statements of Operations or Consolidated Balance Sheets.

Indivior PLC

Notes to the Condensed Consolidated Financial Statements

(Dollars and shares in millions)

(Unaudited)

2. 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 March 31,
	2025		2024
US:
SUBLOCADE	$	163	$	168
Sublingual & other	54		63

PERSERIS1	4		11
Total U.S.	222		241
Rest of World	44		42
Net revenue	266		284
Cost of sales	44		38
Gross profit	221		246

Operating expenses:
Selling and marketing	67		67
Administrative and general	65		77
Total selling, general and administrative	132		143
Research and development	22		28

Litigation settlement	1		—

Total operating expenses	156		171

Operating income	66		75

Other income and expenses:
Interest income	4		7
Interest expense	(12)		(9)
Income before income taxes	59		73

Income tax expense	(11)		(11)

Net income	$	47	$	61

*Total SUBLOCADE net revenue	$	176	179

1Marketing and promotion activities for PERSERIS were discontinued in July 2024.

Indivior PLC

Notes to the Condensed Consolidated Financial Statements

(Dollars and shares in millions)

(Unaudited)

3. Income Tax

Indivior is a global biopharmaceutical company, 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 were as follows:

Our income tax rate for the three months ended March 31, 2025 differs from the U.K. Federal statutory rate of 25%, due primarily to U.K. innovation deductions and intragroup financing transactions, partially offset by a U.K. global minimum top-up tax and share based compensation shortfall tax expense.

Our income tax rate for the three months ended March 31, 2024 differs from the U.K. Federal statutory rate of 25%, due primarily to share based compensation excess tax benefits, intragroup financing transactions, and U.K. innovation deductions.

During the three months ended March 31, 2025, there have been no material changes to the Company's unrecognized tax benefit when compared to the year ended December 31, 2024.

The Company is no longer 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. There are ongoing U.K. and U.S. state and local audits covering 2018-2022. 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 of nil to $65 million.

4. Inventories

Inventories are comprised of:


	March 31, 2025		December 31, 2024
Raw materials and consumables	$	33	$	33
Work in progress	39		51
Finished goods	104		94
Total Inventories, net	$	175	$	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 March 31, 2025 and December 31, 2024, the noncurrent portion of inventory was $12 million and $10 million, respectively and consisted primarily of raw materials and consumables (see Note 13. Revision of Previously Issued Financial Statements).

Indivior PLC

Notes to the Condensed Consolidated Financial Statements

(Dollars and shares in millions)

(Unaudited)

5. Property, Plant and Equipment, Net

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


	March 31, 2025		December 31, 2024
Land and buildings	$	77	$	76
Plant and equipment	78		76
Construction in progress	42		38
Gross property, plant and equipment	197		190
Less: Accumulated depreciation	(92)		(90)
Total property, plant and equipment, net	$	104	$	100

The Company capitalizes interest expense, if material, as part of the cost of construction of property, plant and equipment. Interest expense capitalized was $1 million in the three months ended March 31, 2025 and 2024.

Capital expenditures of $2 million and $1 million were included in accounts payable and accrued expenses at March 31, 2025 and March 31, 2024, respectively.

6. Accounts Payable and Accrued Expenses


	March 31, 2025		December 31, 2024
Accounts payable	$	46	$	63
Accrued employee-related obligations	45		60
Accrued indirect tax and government fees	23		23
Accrued other expenses	69		71
Total accounts payable and accrued expenses	$	183	$	216

Accrued other expenses includes various unbilled costs covering marketing, research and development, legal, consulting and other.

7. Accrued Litigation Settlement Expenses


	March 31, 2025						December 31, 2024
	Current		Non current		Total		Current		Non current		Total
Accrued litigation settlement expenses
DOJ-related	$	50	$	246	$	297	$	52	$	296	$	348
Antitrust claims	19		—		19		24		—		24
Opioid litigation	27		51		78		15		61		76
Other	8		—		8		8		8		16
Total accrued litigation settlement expenses	$	105	$	297	$	402	$	99	$	365	$	464

Indivior PLC

Notes to the Condensed Consolidated Financial Statements

(Dollars and shares in millions)

(Unaudited)

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 three months ended March 31, 2025 with respect to this matter.

Opioid litigation

The accrual of $78 million at March 31, 2025 reflects the present value of the agreed amount in a preliminary 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 three months ended March 31, 2025 in relation to the last remaining antitrust litigation and the remaining accrual of $19 million at March 31, 2025 reflects the NPV at the risk-free rate of the amounts to be paid in 2025. This final settlement resolves all of the Company’s remaining legacy antitrust litigation.

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

8. 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 utilized.

The outstanding balance of the note purchase agreement of $346 million and $350 million as of March 31, 2025 and December 31, 2024, respectively, is secured by substantially all of the assets of subsidiaries of the Company, primarily in the form of guarantees issued by respective subsidiaries. Interest expense was $9 million and $7 million for the three months ended March 31, 2025 and March 31, 2024, respectively.

The Company was in compliance with all debt covenants at March 31, 2025.

9. 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 the equity securities is based on quoted market prices (Level 1 inputs)

Indivior PLC

Notes to the Condensed Consolidated Financial Statements

(Dollars and shares in millions)

(Unaudited)

on the measurement date. The fair value of equity securities at both March 31, 2025 and December 31, 2024 is $1 million.

The fair value of debt at March 31, 2025 and December 31, 2024 is in line with the carrying value as the debt was recently issued, the Company's credit profile has not substantially changed, and the interest rate is a floating market-based rate. The fair value of debt is based on unobservable inputs and would be classified as Level 3 in the hierarchy above.

The fair value of the Company’s corporate debt securities was $27 million and $27 million at March 31, 2025 and December 31, 2024, respectively. The fair value of the 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 March 31, 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.

10. Earnings Per Share

The following table summarizes the calculation of basic and diluted loss per share for the three months ended March 31, 2025 and 2024:


	Three Months Ended March 31,
	2025		2024
Net income	$	47	$	61

Basic weighted-average shares outstanding	124		136
Effect of potentially dilutive securities:
Restricted stock awards1	1		2
Diluted weighted-average shares outstanding	125		137

Basic earnings per share	0.38		0.45
Diluted earnings per share	0.38		0.45

1The potential shares excluded from the diluted earnings per share computation because of the antidilutive impact were nil in three months ended March 31, 2025 and March 31, 2024.

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 3 million and 2 million shares were granted under the Company’s Long-Term Incentive Plan in the three months ended March 31, 2025 and 2024, respectively.

11. 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.

Indivior PLC

Notes to the Condensed Consolidated Financial Statements

(Dollars and shares in millions)

(Unaudited)


	Three Months Ended March 31,
	2025		2024
Compensation expense related to share-based payments	$	6	$	6
Income tax (expense) benefit for share-based payments	(1)		3

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 three months ended March 31, 2025 is presented below (values in thousands):


	Outstanding Service-Based Restricted Share Awards	Outstanding Performance-Based Share Awards
Shares at December 31, 2024	1,036	4,717
Granted	1,773	1,582
Issued	(193)	(286)
Canceled/forfeited/adjusted	(176)	(1,555)
Shares at March 31, 2025	2,440	4,459

The weighted average fair value per share of the service-based restricted share awards granted was $9.70 for the three months ended March 31, 2025, based on the fair market value at the date of grant. The total fair value of restricted share awards issued was $3 million for the three months ended March 31, 2025.

The weighted average fair value per share of the performance-based share awards granted per share was $8.67 for the three months ended March 31, 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 was nil for the three months ended March 31, 2025.

Total compensation cost for unvested awards not yet recognized at March 31, 2025 was approximately $21 million and $25 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 2.6 years and 2.0 years for service-based restricted share awards and performance-based share awards, respectively.

Share Options

The Company did not grant any share options in the three months ended March 31, 2025. No share options were exercised in three months ended March 31, 2025.

12. 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.

Indivior PLC

Notes to the Condensed Consolidated Financial Statements

(Dollars and shares in millions)

(Unaudited)

Civil Opioid Litigation

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"). Nearly two-thirds of the cases in the Opioid MDL were filed by cities and counties, while nearly one-third of the cases were filed by private plaintiffs, most of whom assert claims relating to neonatal abstinence syndrome ("NAS"). Cases brought by cities and counties outside of the MDL include, for example, 35 actions pending in New York state court, 8 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.

Pursuant to mediation, the Company, the Plaintiffs' Executive Committee (PEC) in the Opioid MDL, Tribal Leadership Committee (TLC), and an executive committee of state attorneys general reached agreement on the amount of a potential settlement. The Company has recorded a related provision of $78 million, reflecting the NPV of the agreed amount (See Note 7. Accrued Litigation Settlement Expenses). The Company, PEC, and executive committee of state attorneys general have reached agreement on material settlement terms, with details concerning the timing and structure of payments and product distribution to be agreed upon. The Company and the TLC are in the process of negotiating remaining material settlement terms. These settlements would not resolve private plaintiff cases against the Company (whether in the MDL or proceeding separately).

With respect to cases outside the MDL that were not filed by cities or counties:

Indivior Inc. was named as a defendant in San Miguel Hospital Corp. d/b/a Alta Vista Regional Medical Center v. Johnson & Johnson, et al., No. 1:23-cv-00903 (D.N.M.) on March 18, 2024. On March 4, 2025, the court dismissed the complaint.

On October 28, 2024, Indivior Inc. was named as one of numerous defendants in five 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. The West Virginia Supreme Court has set a briefing schedule under which briefing on the appeal will close on August 4, 2025.

Additionally, 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.

The Company has begun its evaluation of all of the claims, 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 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:

Indivior PLC

Notes to the Condensed Consolidated Financial Statements

(Dollars and shares in millions)

(Unaudited)

Dental MDL Plaintiffs: 1,611 cases naming 3,572 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: On April 14, 2025, the plaintiffs filed an amended Schedule A that reduced the number of Schedule A claimants to 8,575.

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 850 other individuals in Delaware, New Jersey, and Virginia. Complaints have not yet been filed on behalf of the tolled individuals.

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. On January 23, 2025, the appellate court affirmed the dismissal, and on February 19, 2025 the claimants applied for permission to appeal to the Supreme Court on February 19, 2025. The Company opposed, and the court refused the application on February 27, 2025. The claimants have applied directly to the U.K. Supreme Court to further appeal.

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 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 CCO of the Company) as a defendant. The defendants moved to dismiss. On April 22, 2025, the court heard oral argument and granted the motion to dismiss. The court indicated that a formal opinion will follow, and the plaintiffs will have 30 days from the date of the opinion to amend their complaint.

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 the litigation, no estimate of possible loss can be made at this time.

Opiant Shareholder Claims

On November 8, 2023, plaintiff James Litten filed a class action complaint in the Delaware Court of Chancery alleging that former officers and directors of Opiant Pharmaceuticals, Inc. ("Opiant") breached fiduciary duties of care, loyalty, and good faith in connection with Indivior PLC's 2022 acquisition of Opiant. The court heard argument on the motion to dismiss on January 17, 2025 and heard additional argument on February 19, 2025.

Indivior PLC

Notes to the Condensed Consolidated Financial Statements

(Dollars and shares in millions)

(Unaudited)

13. Revision of Previously Issued Financial Statements

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.

Indivior PLC

Notes to the Condensed Consolidated Financial Statements

(Dollars and shares in millions)

(Unaudited)

Consolidated Balance Sheets


	As reported		Adjustment		Revised
	December 31, 2024
Inventories	$	178	$	(10)	$	167
Current tax receivable	34		(1)		33
Total current assets	839		(12)		827
Deferred tax assets	280		(3)		277
Other noncurrent assets	29		10		39
Total assets	$	1,319	$	(4)	$	1,316

Accounts payable and accrued expenses	$	232	$	(16)	$	216

Total current liabilities	939		(16)		924
Total liabilities	1,668		(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 assets	1,266		(9)		1,257
Deferred tax assets	288		(2)		286
Other noncurrent assets	28		9		36
Total assets	$	1,760	$	(2)	$	1,758

Accounts payable and accrued expenses	$	204	$	(10)	$	195
Total current liabilities	1,290		(10)		1,281
Total liabilities	1,951		(9)		1,942
Accumulated deficit	(295)		7		(288)
Total shareholders' deficit	(191)		7		(184)
Total liabilities and shareholders' deficit	$	1,760	$	(2)	$	1,758

Indivior PLC

Notes to the Condensed Consolidated Financial Statements

(Dollars and shares in millions)

(Unaudited)

Consolidated Statements of Operations


	As reported		Adjustment		Revised
	Year ended December 31, 2024
Selling, general and administrative expenses	$	618	$	(6)	$	612
Total operating expenses, net	925		(6)		919
Operating income	32		6		38
Income before income taxes	14		6		20
Income tax expense	(11)		(2)		(13)
Net income	$	2	$	5	$	7

Earnings per Share
Basic	$	0.02	$	0.03	$	0.05
Diluted

Three Months Ended March 31,

Total income before income taxes

Total income tax expense

Total effective tax rate