INDIVIOR PLC

Previous wording

The following discussion of our financial condition and results of operations should be read in conjunction with the unaudited condensed consolidated financial statements included in Part I, Item 1 of this quarterly report on Form 10-Q and with our audited consolidated financial statements, including the accompanying notes, and Management's Discussion and Analysis of Financial Condition and Results of Operations, included in our Annual Report on Form 10-K for the year ended December 31, 2024. As discussed in Note 13. Revision of Previously Issued Financial Statements, the Company revised its previously issued financial statements to correct an accrual overstatement that did not have a material impact for any of the prior quarters or the annual periods in which they occurred. Amounts included in the discussion below for thethree and six months ended June 30, 2024 reflect the revisions.

Current wording

The following discussion of our financial condition and results of operations should be read in conjunction with the unaudited condensed consolidated financial statements included in Part I, Item 1 of this quarterly report on Form 10-Q and with our audited consolidated financial statements, including the accompanying notes, and Management's Discussion and Analysis of Financial Condition and Results of Operations, included in our Annual Report on Form 10-K for the year ended December 31, 2024. As discussed in Note 14. Revision of Previously Issued Financial Statements, the Company revised its previously issued financial statements to correct an accrual overstatement that did not have a material impact for any of the prior quarters or the annual periods in which they occurred. Amounts included in the discussion below for thethree and nine months ended September 30, 2024 reflect the revisions.

Previous wording

For the periods presented, the Company operated as one business segment, which is predominantly the development, manufacture and sale of buprenorphine-based prescription drugs for the treatment of opioid dependence and related disorders, and nalmefene nasal spray for emergency opioid overdose reversal. Substantially all our net revenue was derived from sales of SUBLOCADE and other buprenorphine-based sublingual products (including SUBOXONE Film, SUBOXONE Tablet and SUBUTEX Tablet). SUBLOCADE accounted for 69% and 68% of our net revenue for the three and six months ended June 30, 2025, respectively, and 64% and 64% for the three and six months ended June 30, 2024, respectively. Other buprenorphine-based sublingual products accounted for 27% and 29% of our net revenue for the three and six months ended June 30, 2025, respectively, and 31% and 32% for the three and six months ended June 30, 2024, respectively. In the U.S., SUBOXONE Film had an oral buprenorphine medically assisted treatment (BMAT) average share of 14.4% and 16.3% in the three months ended June 30, 2025 and 2024, respectively, according to data from IQVIA.

Current wording

The Company operates as one business segment, which is predominantly the development, manufacture and sale of buprenorphine-based prescription drugs for the treatment of opioid dependence and related disorders, and nalmefene nasal spray for emergency opioid overdose reversal. Substantially all our net revenue was derived from sales of SUBLOCADE and other buprenorphine-based sublingual products (including SUBOXONE Film, SUBOXONE Tablet and SUBUTEX Tablet). SUBLOCADE accounted for 70% and 69% of our net revenue for the three and nine months ended September 30, 2025, respectively, and 62% and 63% for the three and nine months ended September 30, 2024, respectively. Other buprenorphine-based sublingual products accounted for 26% and 28% of our net revenue for the three and nine months ended September 30, 2025, respectively, and 30% and 31% for the three and nine months ended September 30, 2024, respectively. In the U.S., SUBOXONE Film had an oral buprenorphine medically assisted treatment (BMAT) average share of 14.0% and 15.3% in the three months ended September 30, 2025 and 2024, respectively, according to data from IQVIA.

Previous wording

In July 2025, the Company completed cancellation of its London Stock Exchange listing and now trades exclusively on Nasdaq, which aligns to the Company's capital markets footprint and a stronger focus on SUBLOCADE growth in the U.S. Effective June 30, 2025, the Company became a member of the U.S. small-cap Russell 2000® Index and the broad-market Russell 3000® Index.

Current wording

In July 2025, the Company cancelled its London Stock Exchange listing and now trades exclusively on Nasdaq under the symbol "INDV", which aligns to the Company's capital markets footprint and a stronger focus on SUBLOCADE growth in the U.S.

Previous wording

Net revenue for the three and six months ended June 30, 2025 and 2024 was driven by sales of SUBLOCADE and other buprenorphine-based sublingual products (including SUBOXONE Film and SUBOXONE Tablet).

Current wording

Net revenue for the three and nine months ended September 30, 2025 and 2024 was driven by sales of SUBLOCADE and other buprenorphine-based sublingual products (including SUBOXONE Film and SUBOXONE Tablet).

Previous wording

Total net revenue increased by $3 million, or 1%, and decreased by $15 million, or 3%, in the three and six months ended June 30, 2025, respectively, and U.S. net revenue increased by $1 million and decreased by $18 million, or 4%, in the three and six months ended June 30, 2025, respectively, as compared to the same periods in 2024.

Current wording

Total net revenue increased by $7 million, or 2%, and decreased by $8 million, or 1%, in the three and nine months ended September 30, 2025, respectively, and U.S. net revenue increased by $6 million, or 2%, and decreased by $12 million, or 2%, in the three and nine months ended September 30, 2025, respectively, as compared to the same periods of 2024.

Previous wording

U.S. net revenue. The U.S. is our largest market. Rebates, discounts and returns and other offsets to gross revenues are reflected in net revenue. U.S. net revenue from SUBLOCADE increased by $17 million, or 9%, and $13 million, or 4%, in the three and six months ended June 30, 2025, respectively, as compared to the same periods in 2024, reflecting volume increases and the benefit of changes in estimate related to rebate accruals. U.S. net revenue from other products declined $16 million and $31 million in the three and six months ended June 30, 2025, reflecting the impact of increased competitive activity resulting in lower pricing and market share in the U.S. for SUBOXONE Film and the decline in PERSERIS net revenue following the decision to discontinue commercial sales support in July 2024.

Current wording

U.S. net revenue. The U.S. is our largest market. Rebates, discounts and returns and other offsets to gross revenues are reflected in net revenue. U.S. net revenue from SUBLOCADE increased by $25 million, or 14%, and $38 million, or 7%, in the three and nine months ended September 30, 2025, respectively, as compared to the same periods in 2024, reflecting increase dispenses, the benefit of changes in estimate related to rebate accruals of $10 million, and a stocking benefit of $4 million. U.S. net revenue from other products declined $19 million and $50 million in the three and nine months ended September 30, 2025, reflecting the impact of increased competitive activity resulting in lower pricing and market share in the U.S. for SUBOXONE Film. Lower OPVEE volumes in 2025 and the decline in PERSERIS net revenue following the decision to discontinue commercial sales support in July 2024 also contributed to the net revenue decline in the three and nine months ended September 30, 2025. During the third quarter of 2025, the Company made a strategic decision to discontinue sales and marketing support for OPVEE, although it will continue to distribute OPVEE upon request and meet all required contractual and regulatory obligations.

Previous wording

Rest of the World net revenue. In the three and six months ended June 30, 2025, net revenue attributable to Rest of the World increased by $2 million, or 5%, and$3 million, or 4%, respectively, as compared to the same periods in 2024, reflecting positive contributions from newer products (SUBLOCADE / SUBUTEX® Prolonged Release and SUBOXONE Film) that were partially offset by ongoing generic erosion of the legacy tablet business. In the three and six months ended June 30, 2025, SUBLOCADE / SUBUTEX Prolonged Release net revenue in Rest of World was $14 million and $27 million, respectively, as compared to $13 million and$25 million for the same periods in 2024, respectively. We expect incremental growth from new products to continue to at least offset the decline in the legacy tablet business in 2025.

Current wording

Rest of the World net revenue. In the three and nine months ended September 30, 2025, net revenue attributable to Rest of the World increased by $1 million, or 2%, and$4 million, or 3%, respectively, as compared to the same periods in 2024, reflecting positive contributions from newer products (SUBLOCADE / SUBUTEX® Prolonged Release and SUBOXONE Film) that were partially offset by ongoing generic erosion of the legacy tablet business. In the three and nine months ended September 30, 2025, SUBLOCADE / SUBUTEX Prolonged Release net revenue in Rest of World was $16 million and $43 million, respectively, as compared to $13 million and$38 million for the same periods in 2024, respectively. We expect incremental growth from new products to continue to more than offset net revenue declines in the legacy tablet business in 2025, though Rest of World net revenue will be impacted by our plansto exit several non-U.S. markets. The countries in which we will continue operations or distribution represent 77% of forecasted Rest of World net revenue.

Previous wording

Estimates, assumptions and judgements applied to determine the provision for rebates, discounts and returns are set out in "Item 8. Financial Statements—Note 2. Summary of Significant Accounting Policies"in our Annual Report on Form 10-K for the year ended December 31, 2024.

Current wording

Estimates, assumptions and judgments applied to determine the provision for rebates, discounts and returns are set out in "Item 8. Financial Statements—Note 2. Summary of Significant Accounting Policies"in our Annual Report on Form 10-K for the year ended December 31, 2024.

Previous wording

The following table provides a summary of activities with respect to accrued rebates and product returns and prompt pay discounts for the six months ended June 30, 2025:

Current wording

The following table provides a summary of activities with respect to accrued rebates and product returns and prompt pay discounts for the nine months ended September 30, 2025:

Previous wording

Accrued rebates and product returns include chargebacks as these are paid by Indivior. Prompt pay discounts are recorded as offsets to accounts receivable as of June 30, 2025. Accrued rebates and product returns and prompt pay discounts increased to $712 million as of June 30, 2025 from $592 million as of June 30, 2024, primarily as a result of the timing of payment of government rebates due to late receipt and processing of invoices. The processing time also favorably impacted our cash balance at June 30, 2025. We expect rebate payments to increase in the third quarter and the accrual balance to revert to levels more in line with those at the 2024 year-end.

Current wording

Accrued rebates and product returns include chargebacks as these are paid by Indivior. Prompt pay discounts are recorded as offsets to accounts receivable as of September 30, 2025. Accrued rebates and product returns and prompt pay discounts increased to $616 million as of September 30, 2025 from $608 million as of September 30, 2024.

Previous wording

Gross margin, which we define as gross profit divided by net revenue, was 83% and 83% in the three and six months ended June 30, 2025, respectively, as compared to 74% and 80% in the same periods in 2024, respectively. The increase primarily reflects costs of $41 million in the 2024 periods related to the discontinuation of marketing and promotion of PERSERIS. We expect gross margin to continue in the low-to-mid 80 percent range for the remainder of 2025.

Current wording

Gross margin, which we define as gross profit divided by net revenue, was 73% and 80% in the three and nine months ended September 30, 2025, respectively, as compared to 79% and 79% in the same periods of 2024, respectively. The changes were primarily driven by the cost of sales factors described above. In addition, both periods of 2025 benefited from favorable mix reflecting SUBLOCADE volume growth and the benefit of changes in estimates related to rebate accruals.

Previous wording

Selling, general and administrative expenses. Selling, general and administrative expenses increased by $6 million, or 4%, anddecreased by$5 million, or 2%, in the three and six months ended

Current wording

Selling, general and administrative expenses. Selling, general and administrative expenses increased by $13 million, or 9%, andincreased by$8 million, or 2%, in the three and nine months ended September 30, 2025, respectively, as compared to the same periods of 2024. Selling, general and administrative expenses in the three and nine months ended September 30, 2025 include$22 million ofcorporate transition initiative costs related to Phase 1 of the Indivior Action Agenda announced in August 2025. Selling, general and administrative expenses in the same periods of 2024 include$9 million and$12 million, respectively, of severance and other costs associated with the discontinuation of marketing and promotion of PERSERIS. Investments in U.S. SUBLOCADE marketing contributed$6 million and$21 million, respectively, of the increase in thethree and nine months ended September 30, 2025. Both periods of 2025 also benefited from streamlining actions taken in 2024, including narrowing the Company's commercial focus on OUD treatments and discontinuing marketing and promotion of PERSERIS.

Previous wording

Research and development expenses. Research and development expenses decreased by $5 million, or 20%, and $11 million, or 20%, in the three and six months ended June 30, 2025, respectively, as compared to the same periods in 2024, primarily reflecting the Company's actions to refocus its development pipeline on the Phase 2 OUD assets (INDV-2000 and INDV-6001). We expect research and development expenses to continue to track below 2024 levels throughout 2025.

Current wording

Research and development expenses. Research and development expenses increased by $11 million, or 48% in thethree months ended September 30, 2025 and remained flat in the nine month period, as compared to the same periods of 2024. Research and development expenses in the three and nine months ended September 30, 2025 included the impact of$13 million ofrestructuring and impairment costs related to Phase 1 of the Indivior Action Agenda announced in August 2025. Excluding these impacts, lower research and development costs primarily reflect the Company's actions to refocus its development pipeline on the Phase 2 OUD assets (INDV-2000 and INDV-6001). We expect research and development expenses to continue to track below 2024 levels through the remainder of the year.

Previous wording

Net interest expense. Net interest expense was $10 million and $17 million in the three and six months ended June 30, 2025, respectively, as compared to net interest expense of $3 million and $5 million in the three and six months ended June 30, 2024. Higher net interest expense in the 2025 periods includes $4 million related to an expected U.K. tax settlement and reflected interest expense on the larger amount borrowed under the Company's new borrowing arrangement secured in late 2024 as well as a decrease in interest income on lower investment balances.

Current wording

Net interest expense. Net interest expense was $6 million and $23 million in the three and nine months ended September 30, 2025, respectively, as compared to net interest expense of $5 million and $10 million in the three and nine months ended September 30, 2024. Higher net interest expense in the nine months ended September 30, 2025 includes $4 million related to an expected U.K. tax settlement and reflects interest expense on the larger amount borrowed under the Company's new borrowing arrangement secured in late 2024.

Previous wording

Income tax expense (benefit). Income tax expense of $44 million and $56 million in the three and six months ended June 30, 2025, respectively, as compared to income tax benefit of $23 million and $12 million in the three and six months ended June 30, 2024, resulted in an effective tax rate of 71% and 46% in the three and six months ended June 30, 2025, respectively. Both periods benefited from intragroup financing transactions; however, in the three and six months ended June 30, 2025 this benefit was fully offset by a tax reserve for an HMRC settlement which became probable during the quarter and a U.K. global minimum top-up tax. The HMRC settlement relates to aspects of prior years' intercompany financing arrangements and is not expected to impact our future tax rates. In the three and six months ended June 30, 2024, the Company recognized a share-compensation excess tax benefit.

Current wording

Income tax expense (benefit). Income tax benefit of $5 million and income tax expense of $50 million in the three and nine months ended September 30, 2025, respectively, as compared to income tax expense of $8 million and income tax benefit of $4 million in the three and nine months ended September 30, 2024, resulted in an effective tax rate of 14% and 32% in the three and nine months ended September 30, 2025, respectively. Both periods benefited from intragroup financing transactions; however, in the nine months ended September 30, 2025 this benefit was fully offset by a tax reserve for an HMRC settlement. During the three months ended September 30, 2025, HMRC's acceptance of our proposed settlement within calendar year 2025 became probable. Accordingly, the settlement payment is expected to be treated as a covered tax, effectively eliminating our Pillar II top-up tax expense for the year. Neither the settlement cost nor the resulting Pillar II elimination are expected to recur in future periods. In the three and nine months ended September 30, 2024, the Company incurred disallowed expenses, offset by share-compensation excess tax benefits and intragroup financing transaction benefits.

Previous wording

In July 2025, legislation commonly referred to as the One Big Beautiful Bill Act 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 is evaluating the implications of these tax law changes and does not currently anticipate significant impacts.

Current wording

In July 2025, legislation commonly referred to as 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 is evaluating the implications of these tax law changes and does not currently anticipate material impacts.

Previous wording

Many risks and uncertainties are discussed in the Risk Factors section in Item 1A of our Annual Report on Form 10-K filed March 3, 2025 and Quarterly Report on Form 10-Q filed May 1, 2025, which we incorporate by reference herein. In addition to that discussion, we note continuing uncertainty regarding U.S. federal government tariffs, and changes thereto, may impact our revenues. Also, we note that approximately 85% of our revenues are derived from sales within in the U.S. and all of our key products, chiefly SUBLOCADE, OPVEE and SUBOXONE Film are manufactured primarily in the U.S. However, it remains unclear whether the tariffs will apply to raw materials and work in process which are part of our pharmaceutical manufacturing process, and whether tariffs apply to intellectual property owned by our U.K. subsidiary and licensed to other members of our group, including our U.S. subsidiary. Additionally, we do not know whether other countries will impose retaliatory tariffs that may impact the sale of our products and our margins outside of the United States.

Current wording

Many risks and uncertainties are discussed in the Risk Factors section in Item 1A of our Annual Report on Form 10-K filed March 3, 2025 and Quarterly Reports on Form 10-Q filed May 1, 2025 and July 31, 2205, Part II Item 1A herein, and our other filings with the U.S. Securities and Exchange Commission.

Previous wording

innovative or higher cost treatments could be deprioritized or removed from states formularies, changes to Medicaid funding and eligibility rules, including more frequent redeterminations for beneficiaries receiving coverage through Medicaid, and a requirement for adults made eligible under the ACA to meet work or community engagement standards (from which persons with substance use disorder are exempt); changes to federal requirements regarding Medicaid state directed payments and provider taxes; and establishes a new rural health transformation program, among other provisions. Additional federal and state guidance is expected to be issued in order to implement these OBBBA provisions, most of which have effective dates in 2027 and 2028. Additionally, in June 2025, CMS finalized the Marketplace Integrity and Affordability Regulation which modifies the ACA exchange open enrollment periods and eligibility for premium tax credits among other requirements.

Current wording

The budget reconciliation legislation of 2025, the OBBBA, was signed into law in July 2025. The OBBBA contains a variety of provisions that could impact our business and results of operations, and States, Medicaid plans and providers may respond to policy and sector change by limiting patient eligibility and care delivery in ways that affect access to treatment for OUD, including: innovative or higher cost treatments could be deprioritized or removed from states formularies; changes to Medicaid funding and eligibility rules, including more frequent redeterminations for beneficiaries receiving coverage through Medicaid; a requirement for adults made eligible under the Affordable Care Act ("ACA") to meet work or community engagement standards (from which persons with substance use disorder are exempt); changes to federal requirements regarding Medicaid state directed payments and provider taxes; and establishes a new rural health transformation program, among other provisions. Additional federal and state guidance is expected to be issued in order to implement these OBBBA provisions, most of which have effective dates in 2027 and 2028. Additionally, in June 2025, CMS finalized the Marketplace Integrity and Affordability Regulation which modifies the ACA exchange open enrollment periods and eligibility for premium tax credits, among other requirements.

Previous wording

Net cash provided by operating activities was $233 million and $51 million during the six months ended June 30, 2025 and 2024, respectively, an increase of net cash provided of $182 million. Net cash provided by operating activities in the six months ended June 30, 2025 reflected higher cash generated from operations and benefited from timing of receipt and processing of approximately $120 million in government rebate invoices, most of which were paid in July 2025.

Current wording

Net cash provided by operating activities was $194 million and $53 million during the nine months ended September 30, 2025 and 2024, respectively, an increase of $141 million. Net cash provided by operating activities in the nine months ended September 30, 2025 primarily reflected higher cash generated from operations.

Previous wording

Net cash used in investing activities was $22 million and net cash provided by investing activities was $26 million in the six months ended June 30, 2025 and 2024, respectively, a decrease of net cash provided of $49 million. The change reflects lower proceeds from maturities of investments, partly offset by an increase in capital expenditures.

Current wording

Net cash used in investing activities was $42 million and net cash provided by investing activities was $61 million in the nine months ended September 30, 2025 and 2024, respectively, a decrease of $103 million. The change reflects lower proceeds from maturities of investments, partly offset by an increase in capital expenditures.

Previous wording

We expect approximately $50 million to $70 million of capital expenditures for the full year 2025, primarily to finalize the SUBLOCADE suite at the Raleigh Manufacturing Facility, after which time we expect capital expenditures to revert to levels more in line with Indivior’s history.

Current wording

We expect approximately $45 million to $55 million of capital expenditures for the full year 2025 and an additional $35 million to $45 million in 2026, primarily related to the Raleigh Manufacturing Facility SUBLOCADE suite.

Previous wording

The Company expects to continue evaluating investment opportunities in commercial and development stage assets, with no current commitments.

Current wording

The Company expects to continue evaluating investment opportunities in commercial stage assets, with no current commitments.

Previous wording

Net cash used in financing activities decreased by $70 million in the six months ended June 30, 2025. Net cash used in financing activities in the current period primarily reflects lower cash outflows for shares repurchased and canceled and the settlement of tax on equity awards, partially offset by higher scheduled amortization payments under the Company's new debt facility. In 2025, the annual scheduled amortization is 5% of the original gross loan balance.

Current wording

30, 2025. Net cash used in financing activities in the current period primarily reflects lower cash outflows for shares repurchased and canceled and the settlement of tax on equity awards, partially offset by higher scheduled repayments under the Company's new debt facility. In 2025, the annual scheduled repayments are 5% of the original gross loan balance.

Previous wording

Our current liabilities exceed our current assets by$106 million and total liabilities exceed our total assets by$257 million. The Company sustains negative working capital because of the timing of rebate payments relative to the collection of accounts receivable.

Current wording

Our current liabilities exceed our current assets by$43 million and total liabilities exceed our total assets by$207 million. The Company sustains negative working capital because of the timing of rebate payments relative to the collection of accounts receivable.

Previous wording

Our contractual obligations as of June 30, 2025, which require material cash requirements in the future, consist of debt repayments, litigation settlements, commercial commitments related to contract manufacturing and supply of materials, capital expenditures, lease and employee-related obligations, contractual milestones and contingent value rights. Refer to"Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations" of our Annual Report on Form 10-K for the year ended December 31, 2024. As of June 30, 2025 no material changes to our contractual obligations have occurred beyond the ordinary course of business.

Current wording

Our contractual obligations as of September 30, 2025 that require material cash requirements in the future consist of debt repayments, litigation settlements, commercial commitments related to contract manufacturing and supply of materials, capital expenditures, lease and employee-related obligations, and contractual milestones. Refer to"Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations" of our Annual Report on Form 10-K for the year ended December 31, 2024. As of September 30, 2025 no material changes to our contractual obligations have occurred beyond the ordinary course of business.