Supernus, Inc.
For the period ended Mar 31, 2025. Filed May 1, 2025.
View on SEC.govAbout 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.
Mar 31, 2025 · Filed May 1, 2025
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
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 |
Condensed Consolidated Statements of Operations and Comprehensive Income
| 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 |
Condensed Consolidated Balance Sheets
| 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 shareIssued 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 |
Condensed Consolidated Statements of Stockholders’ Deficit
| 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) | |||||||||
Condensed Consolidated Statements of Cash Flows
(Amounts in millions)
| 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 |
- 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.
- 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 |
1 Marketing and promotion activities for PERSERIS were discontinued in July 2024.
- 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:
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Total income before income taxes | $59 | $73 |
| Total income tax expense | $11 | $11 |
| Total effective tax rate | 19% | 16% |
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 ofnil to $65 million.
- 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).
- 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.
- 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.
- 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 |
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.
- 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 comp liance with all debt covenants at March 31, 2025.
- 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)
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.
- 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 |
1 The potential shares excluded from the diluted earnings per share computation because of the antidilutive impact werenil 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.
- 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 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 wasnil 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 didnot grant any share options in the three months ended March 31, 2025. No share options were exercised in three months ended March 31, 2025.
- 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
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 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. 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:
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 fidu ciary 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.
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.
- 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.
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 |
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 | $0.02 | $0.03 | $0.05 |
| Year ended December 31, 2023 | |||
| Selling, general and administrative expenses | $569 | $(4) | $565 |
| Total operating expenses, net | 1,076 | (4) | 1,072 |
| Operating loss | (156) | 4 | (152) |
| Loss before income taxes | (149) | 4 | (145) |
| Income tax benefit | 20 | (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, net | 831 | (4) | 827 |
| Operating loss | (81) | 4 | (77) |
| Loss before income taxes | (89) | 4 | (86) |
| Income tax benefit | 44 | (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 reported | Adjustment | Revised | |
|---|---|---|---|
| December 31, 2024 | |||
| Net income | $2 | $5 | $7 |
| Deferred income taxes | 6 | 1 | 7 |
| Change in operating assets and liabilities: | |||
| Inventories | (45) | 2 | (43) |
| Other current and noncurrent assets | 378 | (1) | 377 |
| Other current and noncurrent liabilities | 14 | (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 liabilities | 114 | (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 follows:
| As reported | Adjustment | Revised | |
|---|---|---|---|
| Three months ended March 31, 2024 | |||
| Selling, general and administrative expenses | $145 | $(2) | $143 |
| Total operating expenses, net | 172 | (2) | 171 |
| Operating income | 73 | 2 | 75 |
| Income before income taxes | 71 | 2 | 73 |
| 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, net | 340 | (2) | 338 |
| Operating loss | (119) | 2 | (118) |
| Loss before income taxes | (122) | 2 | (121) |
| Income tax benefit | 24 | — | 23 |
| Net loss | $(98) | $1 | $(97) |
| Three months ended September 30, 2024 | |||
| Selling, general and administrative expenses | $144 | $(2) | $142 |
| Total operating expenses, net | 207 | (2) | 206 |
| Operating income | 34 | 2 | 35 |
| Income before income taxes | 28 | 2 | 30 |
| 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, net | 206 | (2) | 205 |
| Operating income | 44 | 2 | 46 |
| Income before income taxes | 36 | 2 | 38 |
| Income tax expense | (16) | — | (17) |
| Net income | $20 | $1 | $21 |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.