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Indivior Pharmaceuticals, Inc.

For the period ended Dec 31, 2025. Filed Feb 26, 2026.

View on SEC.gov

About this filing

A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2025 · Filed Feb 26, 2026

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

What changed in Management’s Discussion and Analysis?

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Previous report: 10-K

Period ended 2024-12-31; filed 2025-03-03.

0001625297-25-000016

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-K

Period ended 2025-12-31; filed 2026-02-26.

0001628280-26-012237

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 137 previous paragraphs and 112 current paragraphs.

43 unchanged; 33 reworded; 36 added; 56 removed; 5 previous and 0 current paragraphs rearranged.

Tables are not compared: 15 previous and 8 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (36)

Current report

Management’s discussion and analysis of financial condition and results of operations is provided as a supplement to and should be read in conjunction with the consolidated financial statements and related notes in Item 8. Financial Statements—Audited Consolidated Financial Statements to enhance the understanding of our results of operations, financial condition and cash flows.

Current report

Discussion of 2023 results and year-to-year comparisons between 2024 and 2023 that are not included in this Form 10-K can be found in Part II, Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.

Current report

As the leader in long-acting injectable treatments for opioid use disorder (OUD), Indivior is singularly focused on delivering evidence-based treatment and advancing understanding of OUD as a chronic but treatable brain disease. For more than 25 years, we have revolutionized the science of addiction medicine — developing treatments that help people move toward long-term recovery with independence and dignity. Building on this heritage, we are ushering in a new era, renewing our commitment to individuals living with OUD and carrying forward what matters most: compassion, integrity, and science. Together – with science, people living with OUD, public health champions, and communities, we are powering recovery and renewing hope.

Current report

Our net revenue is affected by patient awareness, patient willingness to seek treatment, and the number of eligible healthcare providers available to administer treatment. Competitive dynamics may exert pricing pressure and may also affect decisions by third‑party payors regarding formulary placement and reimbursement coverage. To support increased patient access, we engage with governmental agencies, key opinion leaders in addiction medicine, and healthcare professionals to inform policy development and highlight patient outcomes.

Current report

In 2025, U.S. buprenorphine medication‑assisted treatment (BMAT) volume continued to grow at a mid‑single‑digit rate. The Company continues to expect long‑term U.S. BMAT market growth to remain within the mid‑single‑digit percentage range, reflecting public awareness of the opioid epidemic and approved treatments, as well as regulatory and legislative actions intended to expand access to BMAT therapies. The U.S. long‑acting injectable (LAI) segment grew in the high‑teens percentage range during the period. SUBLOCADE remains the primary long‑acting injectable treatment utilized for opioid use disorder. The Company’s share of the LAI segment has stabilized in the mid‑seventy percent range. The Company expects to continue investing at sustained levels to support further LAI penetration by increasing patient awareness and advancing policies designed to improve patient access to treatment.

Current report

In July 2025, the Company introduced the Indivior Action Agenda, a three-phased, multi-year operational roadmap intended to maximize the potential of the business and make a positive difference in the lives of people living with OUD while creating value for our shareholders.

Current report

In August, 2025, the Company undertook major initiatives as part of Phase I of the Indivior Action Agenda — Generate Momentum — to simplify the organization and establish Indivior's "go forward" operating model.

Current report

In October 2025, the Company continued to execute key strategies against the Action Agenda, announcing optimization of the Rest of World business with plans to exit several non-U.S. markets, including the U.K., Ireland, Sweden, Israel, Finland and Italy. The Company will continue to own and operate its Fine Chemicals Plant in Hull, U.K. and will also continue to sell product and maintain operations in Canada, Australia and France, and sell product in Germany. Collectively, these countries represent 76% of 2025 Rest of World net revenue for the year.

Current report

During the third quarter of 2025, the Company made the strategic decision to discontinue the sales and marketing support for OPVEE, its opioid overdose reversal product. The Company will continue to distribute OPVEE upon request and meet all required contractual and regulatory obligations.

Current report

In relation to these initiatives, the Company recognized $127 million in 2025 primarily relating to headcount reductions, real estate consolidations, asset impairments, consulting services, and contractual termination and related costs. As a result, the Company's total operating expenses are expected to decrease substantially in 2026 compared to 2025.

Current report

Our 2025 and 2024 net revenue was driven by sales of SUBLOCADE. In 2025 and 2024, SUBLOCADE accounted for 69% and 64% of our net revenue, other buprenorphine-based sublingual products accounted for 28% and 32%, and PERSERIS accounted for 2% and 3%, respectively.

Current report

Total net revenue increased by $51 million, or 4%, to $1,239 million in 2025 from $1,188 million in 2024. The increase was primarily driven by year-over-year SUBLOCADE volume growth which offset expected net revenue declines in Sublingual, and PERSERIS. Except for the impact of gross-to-net adjustments discussed below, pricing was not material to net revenue growth.

Current report

The following table presents net revenue between the U.S. and Rest of World.

Current report

The U.S. is our largest market. Rebates, discounts and returns and other offsets to gross revenues are reflected in net revenue. In 2025, U.S. net revenue increased by 4% to $1,053 million as compared to $1,008 million in 2024, primarily driven by U.S. SUBLOCADE, which increased by $91 million, or 13%, to $794 million in 2025 compared to $704 million in 2024. Of the 13% increase in U.S. SUBLOCADE revenues, 7% was driven by dispense unit volume growth and 6% was driven primarily by gross-to-net adjustments. U.S. net revenue from other products declined $46 million in 2025, primarily reflecting the impact of increased competitive activity resulting in lower category share in the U.S. for SUBOXONE Film, partially offset by favorable gross-to-net adjustments in 2025. SUBOXONE Film had an oral buprenorphine medically assisted treatment (BMAT) average share of 14% and 16% in 2025 and 2024, respectively, according to data from IQVIA. Lower OPVEE volumes in 2025 and the decline in PERSERIS net revenue following the decision to discontinue commercial sales support in July 2024 also partially offset the increase in net revenue. During the third quarter of 2025, the Company made a strategic decision to discontinue sales and marketing support for OPVEE. The Company will, however, continue to distribute OPVEE upon request and meet all required contractual and regulatory obligations.

Current report

We expect continued LAI category growth and stable category share to result in U.S. SUBLOCADE net revenue growth in 2026. However, competitive pressures are expected to continue to adversely impact both SUBOXONE Film pricing and volume, resulting in an expected decline in SUBOXONE Film net revenue in 2026. Rest of World net revenue is expected to decline as a result of the exit from certain non-U.S. markets, as described above. We expect negligible revenues from PERSERIS and OPVEE in 2026, as the Company is no longer actively marketing these products. As a result of these factors, the Company's total net revenue in 2026 is expected to decline compared to 2025.

Current report

Research and development expenses decreased by $10 million, or 9%, to $97 million in 2025 from $107 million in 2024. The decrease is primarily due to the Company's actions to refocus its development pipeline on the Phase 2 OUD assets (INDV-2000 and INDV-6001) and the absence of a $4 million contract termination fee incurred in 2024. These reductions were partly offset by $17 million in restructuring and impairment charges recorded in 2025 related to Phase I of the Indivior Action Agenda announced in August 2025. We expect 2026 research and development expenses to be substantially lower than historic levels.

Current report

The Company incurred no acquired in-process research and development expenses in 2025, compared to $1 million in 2024.

Current report

In 2025, the Company recorded net other operating income of $3 million, compared to net other operating expense of $4 million in 2024. Other operating income in 2025 reflects $1 million of realized losses on the sale of equity investments, while other operating expense in 2024 reflected $9 million of mark-to-market losses related to the decline in value of those equity investments.

Current report

We expect $30 million to $40 million of capital expenditures in 2026, primarily related to our Manufacturing Facility in Raleigh, NC.

Current report

Net cash used in financing activities decreased by $72 million, from $102 million in 2024 to $30 million in 2025. Net cash used in financing activities in the current period primarily reflects lower cash outflows for shares repurchases and the settlement of tax on equity awards in 2025 compared to 2024. These lower financing cash outflows are partially offset by higher scheduled repayments under the Company's Note Purchase Agreement (see Debt below). In 2025 and 2026, the annual scheduled repayments are 5% of the original gross loan balance.

Current report

1 Cash outflows related to debt include payment of the outstanding balance of the note purchase agreement of $333 million as well as estimated interest payments

Current report

2 Cash outflows related to Civil Opioid litigation of approximately $86 million, expected to be paid over the next four years, are excluded from the table as they were not contractual obligations as of December 31, 2025. See Item 8. Financial Statements—Audited Consolidated Financial Statements, Note 16. Commitments and Contingencies.
Removed paragraphs (56)

Previous report

The following discussion and analysis of our financial condition and results of operations should be read together with our consolidated financial statements and the related notes in Item 8. Financial Statements—Audited Consolidated Financial Statements. Historically, we prepared our consolidated financial statements in accordance with International Financial Reporting Standards. As part of the Company’s efforts to align with industry peers and prepare for the expected loss of foreign private issuer status, the Company elected to file its 2024 annual report on Form 10-K, including presentation of its consolidated financial statements in accordance with U.S. GAAP. The transition to US GAAP is reflected retrospectively for all periods from the Company’s inception. The following discussion is based on our financial information prepared in accordance with U.S. GAAP and regulations of the SEC. Some of the information contained in this discussion and analysis or set forth elsewhere in this annual report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. Item 1A. Risk Factors includes a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis, as well as Important Cautionary Note Regarding Forward-Looking Statements.

Previous report

Indivior 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 for opioid use disorder and OPVEE (Nalmefene) nasal spray for opioid overdose recovery.

Previous report

(1)On October 10, 2022, Indivior PLC completed a 5:1 share consolidation. The Company’s basic and diluted weighted average number of shares outstanding, basic earnings (loss) per share, and diluted earnings (loss) per share reflect the share consolidation for all periods presented.

Previous report

The U.S. market is the largest contributor to our net revenue. The following table sets out a breakdown of net revenue as between the U.S. and the Most of World.

Previous report

Our net revenue is impacted by the overall growth of the markets where we operate. Market growth is impacted by increased treatment penetration, which is a function of patient awareness and desire to seek treatment, as well as the number of certified physicians available to deliver treatment. Competitive pressures can drive pricing and can also influence decisions of third-party payors regarding inclusion of products on their list of approved drugs covered by insurance. To increase access to treatment for patients, we engage with government agencies, key opinion leaders in addiction and healthcare professionals to bring patient outcomes to the forefront of decision making. Additionally, we engage in non-branded marketing to increase awareness for patients and families impacted by addiction on a country-by-country basis as allowed by local regulations.

Previous report

In 2024, the volume of U.S. buprenorphine medication-assisted treatments (BMAT) grew in mid-single digits. Market growth was adversely impacted by transitory items including Medicaid re-enrollment in many large states and an issue impacting patient coverage approvals with one of the largest pharmacy benefit managers. The Company continues to expect long-term U.S. growth to be sustained in the mid- to high-single digit percentage range due to increased overall public awareness of the opioid epidemic and approved treatments, together with regulatory and legislative actions to increase access to BMAT treatments. In 2024, the Company's share of the market growth was impacted by both competition in the LAI category, which we expect to continue, as well as competition in the oral category.

Previous report

Our fourth largest customer in the U.S. is a specialty pharmacy group which primarily purchases SUBLOCADE and dispenses product to patients through the various channels listed above.

Previous report

The Company records accruals for loss contingencies associated with these legal matters when it is probable that a liability will be incurred, and the amount of the loss can be reasonably estimated. The Company has accrued for these matters and will continue to monitor each related legal issue and adjust accruals as might be warranted based on new information and further developments in accordance with ASC 450-20-25, Contingencies. Developments in legal proceedings and other matters that could cause changes in the amounts previously accrued are evaluated each reporting period. Amounts accrued for legal contingencies often result from a complex series of judgments about future events and uncertainties that rely heavily on estimates and assumptions including timing of related payments.

Previous report

Where the amount and timing of the payment is fixed, the obligation is not interest-bearing and the impact of discounting is significant, these obligations are recorded at their present value, generally using a discount rate appropriate to the obligation or approximating the risk-free rate at the time the Company entered into the obligation.

Previous report

In July 2024, the Company discontinued the marketing and promotion of PERSERIS due to impending market changes that would make the product no longer financially viable. The Company has continued to supply PERSERIS to avoid disruption to patient care but no longer deploys a dedicated sales force.

Previous report

On March 2, 2023, the Company acquired 100% of the share capital of Opiant, which at the time was a publicly traded company in the U.S., for upfront cash consideration of $146 million and an additional amount to be potentially paid upon achievement of net sales milestones. Opiant was a specialty pharmaceutical company focusing on developing drugs for addictions and drug overdose. As a result of the acquisition, the Company added OPVEE, formerly the pipeline product OPNT003, an opioid overdose treatment well-suited to confront illicit synthetic opioids like fentanyl, to its portfolio. OPVEE was approved by the FDA in May 2023 and launched in October 2023.

Previous report

The Consolidated Financial Statements for the year ended December 31, 2023 include the results of operations of the acquisition of Opiant since the acquisition date. As substantially all of the fair value of the gross assets acquired was concentrated in the value of the OPVEE in-process research and development asset, the acquisition was accounted for as an asset acquisition and total purchase consideration was allocated to the assets acquired and liabilities assumed based on their relative fair values as of the date of acquisition. The Company recorded a charge for in-process research and development associated with OPVEE for $120 million. As part of the acquisition, a subsidiary of Indivior issued Contingent Value Rights (“CVRs”) to the shareholders of Opiant. Total potential payments could be up to a maximum of $68 million over a period through September 30, 2030.

Previous report

On July 31, 2023, the Company acquired full rights to the patents and other assets underlying INDV-2000 (oral Orexin-1 receptor antagonist) from C4X Discovery for $21 million, which was expensed as in-process research and development. As a result, the Company no longer has any obligation to pay future development or sales milestones or a royalty on net sales of this product candidate.

Previous report

On October 11, 2023, the Company secured global rights to develop, manufacture, and commercialize Alar Pharmaceuticals Inc.’s (“Alar”) portfolio of buprenorphine-based ultra long-acting injectables, including lead asset ALA-1000 (now INDV-6001), which is potentially the first three-month LAI for OUD. The Company made an option payment of $5 million and an upfront payment of $10 million, each of which was expensed as in-process research and development. Alar is entitled to potential milestone payments if various developmental, regulatory, and commercial goals are achieved, and royalties in the low double digit to mid-teens as a percentage of net revenue.

Previous report

On November 1, 2023, the Company acquired an aseptic manufacturing facility in the U.S. for upfront consideration of $5 million in cash and assumption of certain contract manufacturing obligations. The facility will be further developed to secure the long-term production and supply of SUBLOCADE.

Previous report

The acquisition of the manufacturing facility has been accounted for as a business combination using the acquisition method of accounting. The assets acquired and liabilities assumed were recorded at fair value, with the excess of the purchase price over the fair value of the identifiable assets and liabilities recognized as $5 million of goodwill. A liability was recorded at fair value to reflect the present value of the expected losses from assumed contractual manufacturing obligations. Net operating losses attributable to these contractual obligations will be recorded against the liability from the date of acquisition through fulfillment of the contracts in late 2025.

Previous report

See Item 8. Financial Statements—Audited Consolidated Financial Statements -Note 18. Asset Acquisitions and Note 19. Business Combinations for more information on these transactions.

Previous report

Net revenue. Our 2024 and 2023 net revenue was driven by sales of SUBLOCADE and other buprenorphine-based sublingual products (including SUBOXONE Film and SUBOXONE Tablet). In 2024 and 2023, SUBLOCADE accounted for 64% and 58% of our net revenue, other buprenorphine-based sublingual products accounted for 32% and 38%, and PERSERIS accounted for 3% and 4%, respectively. SUBLOCADE volume growth was the primary driver of the increase in 2024 net revenue as compared to 2023. In 2024, the first OPVEE orders from BARDA were fulfilled. Price changes were not a significant driver of the increase in net revenue.

Previous report

Total net revenue increased by $95 million, or 9%, to $1,188 million in 2024 from $1,093 million in 2023. The increase was primarily driven by double-digit year-over-year SUBLOCADE volume growth and the fulfillment of OPVEE orders from BARDA. Pricing was not material to net revenue growth. Higher net revenue from SUBLOCADE, which increased by $126 million, or 20%, from 2023 reflected further organized health system (OHS) channel penetration in the U.S. and increased new U.S. patient enrollments. 2024 SUBLOCADE growth was impacted by competition in the US LAI categoryand transitory items including Medicaid re-enrollment in many large states and an issue impacting patient coverage approvals with one of the largest pharmacy benefit managers. SUBOXONE Film net revenue declined 10% in 2024 and Film share averaged 16% and 19% in 2024 and 2023 and was 15% and 18% as of December 31, 2024 and 2023, respectively. In 2024, total net revenue from PERSERIS was $40 million, representing a 5% decrease from 2023 due to a decline in volume and the impact of discontinuation of PERSERIS in the second half of 2024.

Previous report

The U.S. market is the largest contributor to our net revenue. Sales rebates, discounts and returns and other offsets to gross revenues are reflected in net revenue. The following table sets out a breakdown of net revenue between the U.S. and Most of World.

Previous report

In 2024, U.S. net revenue increased by 11% to $1,008 million as compared to $912 million in 2023, primarily due to strong SUBLOCADE volume growth, supported by favorable mix between commercial and governmental channels for SUBOXONE and SUBLOCADE. Fulfillment of OPVEE orders from BARDA also contributed, offset by lower SUBOXONE revenue.

Previous report

Competitive dynamics and near-term Justice Systems funding challenges are expected to offset potential LAI category growth, resulting in modest SUBLOCADE net revenue growth in 2025. Competitive pressures, including from a potential fifth generic Film entrant, are expected to adversely impact both pricing and volume, resulting in an accelerated decline in Film net revenue in 2025. We also expect almost no revenues from PERSERIS in 2025 as a result of our decision to cease all marketing efforts in July 2024, although we continue to supply PERSERIS during a transition period. Together, these factors are expected to produce an overall decline in total net revenue and operating income in 2025 as compared to 2024.

Previous report

Cost of sales. Cost of sales increased by $57 million, or 32%, to $231 million in 2024 from $174 million in 2023. Cost of sales in 2024 includes $41 million of expenses related to the discontinuation of sales and marketing for PERSERIS and reflects the impact of cost inflation.

Previous report

Research and development expenses. Research and development expenses decreased by $9 million, or 8%, to $107 million in 2024 from $116 million in 2023. The decrease is primarily due to re-prioritization of pipeline activities on the Company's OUD assets as well as related cost savings.

Previous report

Other operating expense (income), net. In 2024, net other operating expense was $4 million and in 2023 net other operating income was $9 million. In 2024, net other operating expense included $9 million mark-to-market adjustments related to the decline in value of an equity investment. In 2023, net other operating income included $3 million of income recognized in relation to a supply agreement.

Previous report

(1)The Company recognized provisions in 2023 and 2022 related to certain multi-district antitrust claims (refer to Item 8. Financial Statements—Audited Consolidated Financial Statements -Note 16. Commitments and Contingencies) and an intellectual-property-related matter.

Previous report

Net revenue. Substantially all of the Company's 2023 and 2022 net revenue was derived from sales of SUBLOCADE, PERSERIS and other buprenorphine-based sublingual products (including SUBOXONE Film and SUBOXONE Tablet). In 2023 and 2022, SUBLOCADE accounted for 58% and 45% of our net revenue, PERSERIS accounted for 4% and 3%, and other buprenorphine-based sublingual products accounted for 39% and 52%, respectively. SUBLOCADE volume growth was the primary driver of the increase in 2023 net revenue as compared to 2022. Price changes were not a significant driver of the increase in net revenue.

Previous report

Total net revenue increased by $192 million, or 21%, to $1,093 million in 2023 from $901 million in 2022. The increase was primarily driven by strong year-over-year SUBLOCADE and PERSERIS volume growth, partly offset by a reduction in SUBOXONE Film share. Higher net revenue from SUBLOCADE, which increased by $222 million, or 54%, from 2022 reflected further organized health system (OHS) channel penetration in the U.S. and increased new U.S. patient enrollments. In 2023, total net revenue from PERSERIS was $42 million, representing a 50% increase from 2022 due to increasing awareness of the treatment across the U.S. healthcare system. SUBOXONE Film share averaged 19% and 20% and exited at 18% and 19% in 2023 and 2022, respectively.

Previous report

The following table sets out a breakdown of net revenue as between the U.S. and the Most of World.

Previous report

In 2023, U.S. net revenue increased by 25% to$912 million as compared to$732 million in 2022, primarily due to strong SUBLOCADE volume growthand underlying BMAT market growth.

Previous report

In 2023, net revenue attributable to the Most of World increased 7% to$181 million from$169 million in 2022. In 2023, positive contributions from new products (SUBLOCADE / SUBUTEX® Prolonged Release and SUBOXONE Film) were partly offset by ongoing competitive pressure on legacy tablet products. In 2023 and 2022, SUBLOCADE / SUBUTEX Prolonged Release net revenue in the Most of World was $41 million and $27 million, respectively.

Previous report

Accrued rebates and product returns and prompt pay discounts includes chargebacks as these are paid by Indivior. Accrued rebates and product returns and prompt pay discounts increased to $535 million in 2023 from $432 million in 2022, primarily due to strong SUBLOCADE volume growth.

Previous report

Cost of sales. Cost of sales increased by $23 million, or 15%, to $174 million in 2023 from $151 million in 2022, driven by higher sales volumes in the U.S. and the impacts of cost inflation.

Previous report

Gross margin, which we define as gross profit divided by net revenue, was 84% in 2023 as compared to 83% in 2022. The increase in 2023 gross margin reflected an improved product mix from the continued growth of SUBLOCADE, partly offset by cost inflation.

Previous report

Selling, general and administrative expenses. Selling, general and administrative expenses increased by $100 million, or 21%, to $569 million in 2023 from $469 million in 2022. Approximately $22 million of this increase relates to acquisition-related and U.S. exchange listing costs. The remaining increase primarily reflects higher expenses related to increased SUBLOCADE commercial investments, the addition of the Opiant business and subsequent launch expenses for OPVEE, legacy legal defense costs and cost inflation.

Previous report

Research and development expenses. Research and development expenses increased by $42 million, or 57%, to $116 million in 2023 from $74 million in 2022. The increase is primarily due to a greater activity level related to post-marketing studies for SUBLOCADE, process validation testing related to LAI capacity expansion and ongoing early-stage pipeline activities.

Previous report

Acquired in-process research and development expenses. Acquired in-process research and development expenses increased to $162 million as a result of the acquisition of OPVEE, the Orexin-1 receptor antagonist INDV-2000, and the potential three-month LAI INDV-6001.

Previous report

Litigation settlement expenses. Litigation settlement expenses increased primarily due to finalization of settlement negotiations with several anti-trust litigation parties. See Item 8. Financial Statements—Audited Consolidated Financial Statements - Note 11. Accrued Litigation Settlement Expenses.

Previous report

Other operating income, net. Net other operating income was $9 million in 2023 and $8 million in 2022. In 2023, net other operating income included $3 million of income recognized in relation to a supply agreement. In 2022, net other operating income included a $5 million benefit related to an aged Directors' & Officers' insurance claim settlement.

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Reworded paragraphs (33)

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, andnalmefene nasal spray for emergency opioid overdose reversal. Substantially all our net revenue for such periods were derived from sales of SUBLOCADE and other buprenorphine-based sublingual products (including SUBOXONE Film and SUBOXONE Tablet). SUBLOCADE accounted for 64%, 58%, and 45% of our net revenue in 2024, 2023, and 2022, respectively. Other buprenorphine-based sublingual products accounted for 32%, 38%, and 52% of our net revenue in 2024, 2023, and 2022, respectively. In the U.S. market for buprenorphine-based treatments for opioid dependence, SUBOXONE Film had an average market share of 16%, 19% and 20% in 2024, 2023, and 2022, 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. Substantially all our net revenue for 2025 and 2024 was derived from sales of SUBLOCADE and other buprenorphine-based sublingual products (including SUBOXONE Film and SUBOXONE Tablet). SUBLOCADE accounted for 69% and 64% of our net revenue in 2025 and 2024, respectively. Other buprenorphine-based sublingual products accounted for 28% and 32% of our net revenue in 2025 and 2024, respectively.

Previous wording

In the U.S., we have distribution agreements with the three largest wholesalers, which accounted for 55%,54%, and 55% of our global net revenue in 2024, 2023, and 2022, respectively. These wholesalers, in turn, distribute our products through various channels including the following:

Current wording

In the U.S., we have distribution agreements with the three largest wholesalers, which accounted for 51% and 55% of our global net revenue in 2025 and 2024, respectively. These wholesalers, in turn, distribute our products through various channels including the following:

Previous wording

•Commercial managed care. This category comprises insurance programs intended to reduce the cost of providing health benefits and improve the quality of care to their members. One of the most common forms of managed care is the use of a panel or network of healthcare providers that provide care to enrollees. Also within commercial managed care is the Medicare Part D Program, a social insurance program administered by the U.S. government.

Current wording

•Commercial managed care. This category comprises insurance programs intended to reduce the cost of providing health benefits and improve the quality of care to their members. One of the most common forms of managed care is the use of a panel or network of healthcare providers that provide care to enrollees. Also within commercial managed care is the Medicare Part D Program, a program regulated and funded by the U.S. government generally for senior citizens and administered by private insurance companies.

Previous wording

•Pharmacy. This channel covers end customers paying cash directly at the pharmacy. Often, we provide discount coupons to customers where cash is used for payment.

Current wording

•Pharmacy. This channel covers end-customers paying cash directly at the pharmacy. Often, we provide discount coupons to customers who buy our products without pharmaceutical benefit coverage.

Previous wording

In the Most of World, distribution channels differ by country. For example, in France, we engage with different wholesalers, hospitals, pharmacies and individuals, while in Australia, we engage with a single pre-wholesaler that negotiates the import and onward distribution of the products across the country.

Current wording

In the Rest of World, distribution channels differ by country and we may engage with different wholesalers, pre-wholesalers, hospitals, pharmacies and individuals.

Previous wording

•Medicaid, Medicare Part D, and Commercial rebates. These are rebates granted to Medicaid, U.S. federal agencies and commercial managed care providers that purchase products from us. The level of these rebates varies by channel and product. Patients covered by commercial insurance often benefit from coupons to reduce any out-of-pocket payments they would otherwise be required to make.

Current wording

•Medicaid, Medicare Part D, and Commercial rebates. These are rebates granted to Medicaid, U.S. federal agencies and commercial managed care providers that purchase products from us. The level of these rebates varies by channel and product. Patients covered by commercial insurance often benefit from coupons to reduce out-of-pocket payments they would otherwise be required to make.

Previous wording

•Chargebacks. Discounts that occur when contracted indirect customers purchase directly from wholesalers and specialty distributors. Contracted customers generally purchase a product at its contracted price. The wholesaler or specialty distributor, in turn, then generally charges back to the Company the difference between the wholesale acquisition cost and the contracted price paid to the wholesaler or specialty distributor by the customer.

Current wording

•Chargebacks. Discounts are provided when contracted indirect customers purchase directly from wholesalers and specialty distributors. Contracted customers generally purchase a product at its contracted price. The wholesaler or specialty distributor, in turn, then generally charges back to the Company the difference between the wholesale acquisition cost and the contracted price paid to the wholesaler or specialty distributor by the customer.

Previous wording

For further information regarding accrued litigation settlement expenses and other legal proceedings, refer to Item 8. Financial Statements—Audited Consolidated Financial Statements—Note 11. Accrued Litigation Settlement Expenses and Note 16. Commitments and Contingencies.

Current wording

For further information regarding accrued litigation settlement expenses and other legal proceedings, refer to Item 8. Financial Statements—Audited Consolidated Financial Statements— Note 2: Summary of Significant Accounting Poli cies, Note 11. Accrued Litigation Settlement Expenses and Note 16. Commitments and Contingencies.

Previous wording

In 2024, net revenue attributable to Most of World decreased slightly from 2023 to $179 million. In 2024 and 2023, positive contributions from newer products (SUBLOCADE / SUBUTEX® Prolonged Release and SUBOXONE Film) were more than offset by the ongoing generic erosion of the legacy tablet business. In 2024 and 2023, SUBLOCADE / SUBUTEX Prolonged Release net revenue in Most of World was $52 million and $41 million, respectively.

Current wording

In 2025, net revenue attributable to Rest of World increased 4% from 2024 to $186 million. In 2025, positive contributions from newer products (SUBLOCADE and SUBOXONE Film) were partially offset by the ongoing generic erosion of the legacy tablet business. In 2025 and 2024, SUBLOCADE net revenue in Rest of World was $61 million and $52 million, respectively. Rest of World net revenue in 2026 will be impacted by our plansto exit several non-U.S. markets. The countries in which we will continue operations or product distribution represent 76% of 2025 Rest of World net revenue.

Previous wording

We estimate provisions for rebates, discounts and returns based on contractual arrangements with customers or terms of the regulations and/or agreements applicable for transactions with healthcare authorities, and in some cases on assumptions about the attainment of targeted volumes. We recognize returns, discounts, incentives and rebates in the period in which we recognize the underlying sales, as a reduction of gross revenues and as current liabilities on our Consolidated Balance Sheets under trade and other payables or reductions of accounts receivable. The outstanding amounts are affected by changes in gross sales, the provision for net product sales deductions and timing of payments/credits. Estimates, assumptions and judgements applied to determine the provision for rebates, discounts and returns are set out in Item 8. Financial Statements—Audited Consolidated Financial Statements—Note 2. Summary of Significant Accounting Policies.”

Current wording

We estimate provisions for rebates, discounts and returns based on contractual arrangements with customers or terms of the regulations and/or agreements applicable for transactions with healthcare authorities, and in some cases on assumptions about the attainment of targeted volumes. We recognize returns, discounts, incentives and rebates in the period in which we recognize the underlying sales, as a reduction of gross revenues and as current liabilities on our Consolidated Balance Sheets as accrued rebates and product returns or reductions of accounts receivable. The outstanding amounts are affected by the provision for net product sales deductions which management reassesses based on historical data and estimated future activities and the timing of payments/credits. Estimates, assumptions and judgements applied to determine the provision for rebates, discounts and returns are set out in Item 8. Financial Statements—Audited Consolidated Financial Statements—Note 2. Summary of Significant Accounting Policies.

Previous wording

Accrued rebates and product returns includes chargebacks as these are paid by Indivior. Prompt pay discounts are recorded as offsets to accounts receivable as of December 31, 2024. Accrued rebates and product returns and prompt pay discounts increased to $565 million as of December 31, 2024 from $535 million as of December 31, 2023, primarily due to strong SUBLOCADE volume growth.

Current wording

Accrued rebates and product returns includes chargebacks as these are paid by Indivior. Prompt pay discounts are recorded as offsets to accounts receivable as of December 31, 2025. Accrued rebates and product returns and prompt pay discounts increased to $585 million as of December 31, 2025, from $565 million as of December 31, 2024, primarily due to increased SUBLOCADE volume growth.

Previous wording

Discontinuation of marketing and promotion of PERSERIS (2024)

Current wording

Cost of sales increased by $15 million, or 7%, to $246 million in 2025 from $231 million in 2024. The increase reflects higher sales volumes as well as $39 million of expenses related to the discontinuation of sales and marketing of OPVEE, $10 million of SUBLOCADE inventory write-downs for finished goods expected to approach expiration prior to sale, $9 million of inventory write-downs and other costs related to the exit from certain non-U.S. markets, and $5 million for the manufacturing transition of the Company's aseptic facility. Cost of sales in 2024 includes $41 million of expenses related to the discontinuation of marketing and promotion of PERSERIS.

Previous wording

Gross margin, which we define as gross profit divided by net revenue, was 81% in 2024 as compared to 84% in 2023. The decrease in 2024 gross margin included the impact of $41 million of costs related to the discontinuation of sales and promotional activities for PERSERIS and cost inflation, partially offset by improved product mix from the continued growth of SUBLOCADE.

Current wording

Gross margin, defined as gross profit divided by net revenue, was 80% in 2025 as compared to 81% in 2024. The decrease in 2025 gross margin included the impact of the 2025 and 2024 cost of sales factors described above, partially offset by improved product 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 $49 million, or 9%, to $618 million in 2024 from $569 million in 2023. In 2024, selling, general and administrative costs reflect $12 million of costs related to the discontinuation of sales and marketing for PERSERIS and $12 million of severance costs. Higher sales and marketing investments related to SUBLOCADE and OPVEE and cost inflation were partially offset by lower sales and marketing costs due to discontinuation of PERSERIS. Prospectively, savings resulting from restructuring actions and discontinuation of PERSERIS marketing will be partially reinvested to support long-term SUBLOCADE growth.

Current wording

Selling, general and administrative expenses increased by $22 million, or 4%, to $634 million in 2025 from $612 million in 2024. In 2025, selling, general and administrative costs include $61 million associated with corporate initiatives, due to headcount reductions and external legal and consulting support primarily related to Phase I of the Indivior Action Agenda announced in August 2025. The 2025 increase also reflected $62 million higher investments in U.S. SUBLOCADE marketing, including the launch of a new direct to consumer campaign for SUBLOCADE in October 2025. Selling, general and administrative expenses in 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. Prospectively, savings resulting from restructuring actions and discontinuation of sales and marketing of OPVEE will be used to support long-term SUBLOCADE growth.

Previous wording

Acquired in-process research and development expenses. Acquired in-process research and development expenses decreased by $161 million, or 99%, to $1 million in 2024 from $162 million in 2023. The decrease is primarily due to the 2023 acquisition of OPVEE and Orexin-1 receptor antagonist INDV-2000.

Previous wording

Litigation settlement expenses. Litigation settlement expenses decreased by $44 million, or 18%, to $195 million in 2024 from $239 million in 2023. The decrease is primarily due to variability in, and unpredictability of, the timing of settlements of major contingencies. See Item 8. Financial Statements—Audited Consolidated Financial Statements - Note 11. Accrued Litigation Settlement Expenses.

Current wording

Litigation settlement expenses decreased by $192 million, to $3 million in 2025 from $195 million in 2024. The decrease is primarily due to variability in, and unpredictability of, the timing of settlements of major contingencies. See Item 8. Financial Statements—Audited Consolidated Financial Statements - Note 11. Accrued Litigation Settlement Expenses.

Previous wording

Net interest (expense) income. Net interest expense was $18 million in 2024 as compared to net interest income of $8 million in 2023. The increase in net interest expense reflected a $4 million write-off of unamortized deferred financing costs due to early extinguishment of the previous term loan, a decrease in earned interest income on lower cash and investment balances and increased borrowings under the Company's new debt facility. We expect interest expense to continue to exceed investment income.

Current wording

Net interest expense was $23 million in 2025 as compared to $18 million in 2024. Higher net interest expense in 2025 reflects interest expense on the larger amount borrowed under the Company's new borrowing arrangement secured in late 2024. Net interest expense in 2025 includes $4 million related to an expected U.K. tax settlement, and net interest expense in 2024 reflects a $4 million write-off of unamortized deferred financing costs due to early extinguishment of the previous term loan. We expect interest expense on our borrowings to continue to exceed investment income.

Previous wording

Income tax (expense) benefit. Income tax expense in 2024 was $11 million, resulting in an effective tax rate of 76.0%, on the Company's earnings for 2024. The income tax benefit of $20 million in 2023 reflected an effective tax rate of 13.2% on the Company’s earnings for 2023.

Current wording

Income tax expense in 2025 was $29 million, resulting in an effective tax rate of 12%, on the Company's earnings for 2025, driven primarily by tax incentive innovation benefits of which $45 million is related to a one-time royalty payment, offset by an HMRC tax settlement and changes in valuation allowances. Income tax expense of $13 million in 2024 reflected an effective tax rate of 65% on the Company’s earnings for 2024, driven primarily by changes in valuation allowances, offset by a net finance structure benefit.

Previous wording

Net cash provided by operating activities was $36 million in 2024, an increase of $336 million, compared to net cash used in operating activities of $300 million in 2023. The increase was primarily due to 2023 litigation settlement outflows of $387 million, including the State, end payor and direct purchaser Antitrust MDL settlements. Net cash provided by operations in 2024 reflected ongoing operating performance partially offset by scheduled litigation settlement payments of $173 million. Refer to Item 8. Financial Statements—Audited Consolidated Financial Statements—Note 10. Accrued Litigation Expenses for additional details on the litigation-related settlement payments.

Current wording

Net cash used in operating activities was $27 million in 2025, a decrease of $63 million, compared to net cash provided by operating activities of $36 million in 2024. The decrease was driven by $208 million higher litigation settlement payments in 2025, including the optional prepayment of the Company's remaining liability with the U.S. Department of Justice (DOJ), partly offset by higher cash generated from operations in 2025. Refer to Item 8. Financial Statements—Audited Consolidated Financial Statements—Note 10. Accrued Litigation Expenses for additional details on litigation-related settlement payments.

Previous wording

Net cash provided by investing activities was $69 million in 2024, an increase of $164 million, compared to net cash used in investing activities of $95 million in 2023. The prior year use of cash reflects a $129 million outflow for the Opiant acquisition, net of cash acquired. The current year inflows primarily reflect proceeds from maturity of debt investments, partly offset by capital expenditures.

Current wording

Net cash used in investing activities was $66 million in 2025, a decrease of $135 million, compared to net cash provided by investing activities of $69 million in 2024. The decrease primarily reflects lower proceeds from maturities of investments, partly offset by an increase in capital expenditures in 2025 related to the Raleigh Manufacturing Facility SUBLOCADE suite.

Previous wording

Our current liabilities exceed our current assets by over $100 million and total liabilities exceed our total assets by over $300 million. Additionally, the Company could sustain negative working capital because of the timing of rebate payments relative to the collection of accounts receivable (see Item 1A Risk Factors, "Our balance sheet is leveraged, and any reduction in annual sales may adversely affect our liquidity.")

Current wording

Our current liabilities exceed our current assets by over $250 million and total liabilities exceed our total assets by approximately $100 million. The Company sustains negative working capital because of the timing of rebate payments relative to the collection of accounts receivable. See Item 1A Risk Factors, "Our balance sheet is leveraged, and any reduction in annual sales may adversely affect our liquidity.".

Previous wording

In November 2024, the Company refinanced its term loan, repaying in full the previous term loan and replacing it with a new Note Purchase Agreement with principal amount of $350 million that matures in November 2030 and a committed, revolving credit facility of $50 million. As of December 31, 2024, the revolver was undrawn. The Note Purchase Agreement contains financial and non-financial covenants customary for facilities of this nature, including a maximum leverage ratio, a minimum interest coverage ratio, a limitation on disposal of assets, prepayments and redemptions of certain indebtedness, further indebtedness, liens, negative pledges, and limits on share buybacks and redemptions, dividends and other “restricted payments,” subsidiary distributions, investments, mergers and acquisitions and other fundamental changes, sale and lease-back transactions, and a restriction on changes to any material line of business, most of which are subject to various carve-outs, grace periods and qualifications. The Company was in compliance with all covenants as of December 31, 2024. See Item 1A. Risk Factors at "Our term loan contains certain covenants that could limit our ability to plan for or respond to changes in our business."and Item 8. Financial Statements—Audited Consolidated Financial Statements -Note 12. Debtfor additional information. In addition, substantially all of the assets of the Company are pledged to secure this debt. The restrictions under the Note Purchase Agreement substantially limit our ability to obtain other financing, other than the $50 million revolving credit facility.

Current wording

As of December 31, 2025, the Company is subject to a Note Purchase Agreement term loan with an outstanding balance of $333 million. The Note Purchase Agreement matures in November 2030 and includes a committed, revolving credit facility of $50 million of which $50 million is available to be drawn. The Note Purchase Agreement contains financial and non-financial covenants customary for facilities of this nature, including a maximum leverage ratio, a minimum interest coverage ratio, a limitation on disposal of assets, prepayments and redemptions of certain indebtedness, further indebtedness, liens, negative pledges, and limits on share buybacks and redemptions, dividends and other “restricted payments,” subsidiary distributions, investments, mergers and acquisitions and other fundamental changes, sale and lease-back transactions, and a restriction on changes to any material line of business, most of which are subject to various carve-outs, grace periods and qualifications. The Company was in compliance with all covenants as of December 31, 2025. See Item 1A. Risk Factors at "Our term loan contains certain covenants that could limit our ability to plan for or respond to changes in our business."and Item 8. Financial Statements—Audited Consolidated Financial Statements -Note 12. Debt for additional information. In addition, substantially all of the assets of the Company are pledged to secure this debt, and the restrictions under the Note Purchase Agreement substantially limit our ability to obtain other financing, other than the $50 million revolving credit facility.

Previous wording

The Company believes its existing cash and cash equivalents and investments together with cash generated from operations and debt will enable its anticipated cash needs to be met, including working capital, capital expenditures, litigation settlement payments, milestone payments, income taxes, repurchase of ordinary shares, debt repayments and other funding requirements, for at least the twelve-month period following the issuance of this Form 10-K. The Company will have to sustain sales volume performance with no material change in the timing of its collections and rebate payments to maintain necessary liquidity in the near term and to meet our obligations in the long term. The Company is also subject to contingent liabilities as described in Item 8. Financial Statements—Audited Consolidated Financial Statements—Note 16. Commitments and Contingencies.

Current wording

The Company believes its existing cash and cash equivalents and investments, together with cash generated from operations, will meet its anticipated cash needs, including working capital, capital expenditures, litigation settlement payments, milestone payments, income taxes, repurchase of common stock, debt repayments and other funding requirements, for at least the twelve-month period following the issuance of this Form 10-K. The Company relies on cash generated from operation to meet our obligations. The Company is also subject to contingent liabilities as described in Item 8. Financial Statements—Audited Consolidated Financial Statements - Note 16. Commitments and Contingencies.

Previous wording

The Company’s capital expenditures for 2024 reflected the expansion of the Raleigh Manufacturing plant. Capital expenditures in 2023 and 2022 were primarily for equipment used in the manufacture of our products. The Company funded these expenditures from its existing cash balances.

Current wording

Capital expenditures of $66 million in 2025 and $29 million on in 2024 primarily reflect investments in the expansion of the Raleigh Manufacturing Facility. The Company funded these expenditures from its existing cash balances.

Previous wording

The table below sets forth the Company’s anticipated contractual cash flows including bank debt, legal settlement payments (including expected interest payments), share repurchase liabilities and lease liabilities on an undiscounted basis as of December 31, 2024.

Current wording

The table below sets forth the Company’s anticipated contractual cash flows on an undiscounted basis as of December 31, 2025.

Previous wording

The Company is party to collaboration and license arrangements for the development of pharmaceutical and digital products. Milestone payments will be due if various developmental, regulatory and commercial goals are achieved and in certain cases royalties will be payable as a percentage of net revenue, although the Company generally has the right to terminate these agreements at no cost. The Company has no significant milestone payments expected in 2025.

Current wording

The Company is party to collaboration and license arrangements for the development of pharmaceutical products. Milestone payments will be due if various developmental, regulatory and commercial goals are achieved and in certain cases royalties will be payable as a percentage of net revenue, although the Company generally has the right to terminate these agreements at no cost. No material milestone payments are expected in 2026.

Previous wording

The Company is obligated to purchase specified amounts of goods or services under various contract manufacturing and material supply agreements over periods ranging from 1 to 6 years. These agreements could require us to pay approximately $210 million (before annual price index adjustments).

Current wording

The Company is obligated to purchase specified amounts of goods or services under various contract manufacturing and material supply agreements over periods ranging from 1 to 4 years. These agreements could require us to pay approximately $68 million in total over the next 4 years (before annual price index adjustments).

Previous wording

The Company offers various types of reductions from list prices on its products. Products sold in the U.S. are covered by various programs (such as Medicare and Medicaid) under which products are sold at a discount. Rebates are granted to healthcare authorities, and under contractual arrangements with certain customers. Some wholesalers are entitled to chargeback incentives under specific contractual arrangements. Cash discounts may also be granted for prompt payment.

Current wording

The Company offers various types of reductions from list prices on its products. Products sold in the U.S. are covered by various programs (such as Medicare and Medicaid) under which products are provided at a discount. Rebates are granted to healthcare authorities, and under contractual arrangements with certain customers. Some wholesalers are entitled to chargeback incentives under specific contractual arrangements. Cash discounts may also be granted for prompt payment.

Previous wording

The discounts, incentives and rebates described above are estimated based on contractual arrangements with customers or terms of the relevant regulations and/or agreements applicable for transactions with healthcare authorities, and in some cases on assumptions about the attainment of targeted volumes. Several months may pass between the original estimate of rebates due and confirmation of the amount, which may increase the estimation risk. Please refer to the revenue accounting policy for further details.

Current wording

The discounts, incentives and rebates described above are estimated based on contractual arrangements with customers or terms of the relevant regulations and/or agreements applicable for transactions with healthcare authorities. Several months may pass between the original estimate of rebates due and confirmation of the amount, which may increase the estimation risk. Please refer to the revenue accounting policy for further details.

Previous wording

Accruals for product returns are estimated based primarily on analysis of the Company’s historical product return patterns, expected future returns, and contractual agreement terms. Estimated returns are accrued in the period the related revenue is recognized.

Current wording

Accruals for product returns are estimated based primarily on analysis of the Company’s historical product return patterns, supplemented by expected future returns and contractual agreement terms. Estimated returns are accrued in the period the related revenue is recognized.

Previous wording

During 2024 and 2022, net revenue was increased by $28 million and $14 million, respectively, from performance obligations satisfied in prior years, primarily relating to changes in payor mix and resolution of aged accruals for U.S. government programs. During 2023, net revenue was reduced by $9 million from performance obligations satisfied in prior years, primarily relating to differences between invoices received from U.S. government programs as compared to the respective accruals held for those years. The estimates for U.S. governmental and commercial end-payor accruals are also reasonably expected to vary due to shifts between U.S. governmental end-payor sales and U.S. commercial end-payor sales. A 1 percentage point shift between these channels would impact the accrual by $4 million. Due to the number of variables contributing to the accruals for returns, incentives and rebates, further meaningful sensitivity is not able to be provided. Accruals for returns, incentives and rebates are disclosed in Item 8. Financial Statements—Audited Consolidated Financial Statements—Balance Sheet.

Current wording

During 2025 and 2024, net revenue was increased by $87 million and $28 million, respectively, from performance obligations satisfied in prior years, primarily relating to changes in payor mix, actual invoices received and payments made, and resolution of aged accruals for U.S. government and commercial programs. The estimates for U.S. governmental and commercial end-payor accruals are also reasonably expected to vary due to shifts between U.S. governmental end-payor sales and U.S. commercial end-payor sales. A one percentage point shift between these channels would impact the accrual by $4 million. Due to the number of variables contributing to the accruals for returns, incentives and rebates, further meaningful sensitivity is not able to be provided. Accruals for returns, incentives and rebates are disclosed in Item 8. Financial Statements—Audited Consolidated Financial Statements—Balance Sheet.

Previous wording

Also, we must assess the likelihood that we will be able to recover our deferred tax assets. If all or part of our deferred tax assets are not recoverable in the future, we must increase our provision for taxes and reduce our net deferred tax assets to the amount that is more likely than not to be recoverable. To recover deferred tax assets, we must be able to generate sufficient taxable income in the jurisdictions where the deferred tax assets are located. We consider forecasted income, including income that may be generated as a result of certain tax planning strategies, together with future reversals of existing taxable temporary differences, in determining the need for a valuation allowance. As of December 31, 2024, we believe our deferred tax assets are more likely than not to be recovered, with the exception of valuation allowance items as detailed in Item 8. Financial Statements—Audited Consolidated Financial Statements - Note 4. Income Tax. Our ability to realize deferred tax assets could be reduced in the future if our estimates of future forecasted income do not support the realization of our deferred tax assets. Should there be a change in our ability to realize our deferred tax assets, our tax provision would be affected in the period in which such change takes place.

Current wording

We assess the likelihood of recoverability our deferred tax assets. If all or part of our deferred tax assets are not recoverable in the future, we increase our provision for taxes and reduce our net deferred tax assets to the amount that is more likely than not to be recoverable. To recover deferred tax assets, we must generate sufficient taxable income in the jurisdictions where the deferred tax assets are located. We consider forecasted income, including income that may be generated as a result of certain tax planning strategies, together with future reversals of existing taxable temporary differences, in determining the need for a valuation allowance. As of December 31, 2025, we believe our deferred tax assets are more likely than not to be recovered, with the exception of valuation allowance items as detailed in Item 8. Financial Statements—Audited Consolidated Financial Statements - Note 4. Income Tax. The realization of our deferred tax assets depends on the generation of sufficient taxable income in future periods. If actual results differ from our estimates or if our assumptions regarding future taxable income change, we may conclude that some or all of our deferred tax assets are no longer 'more likely than not' to be realized. In that event, we would be required to record an increase to our valuation allowance, which could materially affect our income tax provision and results of operations in the period such determination is made.

Previous wording

The Company is involved in litigation, arbitration and other legal proceedings. These proceedings typically are related to compliance and trade practices, commercial claims, product liability claims, intellectual property rights, and employment and wrongful discharge claims. For each claim or grouping of similar claims, management makes judgments regarding the relative merits and risks within the claims. These judgments inform the Company’s defense strategies, whether a loss or settlement from the claims is probable and whether sufficient information exists to make a reliable estimate of he likely outcome of the claims. Provisions are recognized when the Company has a present legal or constructive obligation, an outflow of resource to settle the obligation when it is probable that a liability will be incurred, and the amount of loss can be reasonably estimated. Management has assessed as “contingent” matters that cannot be reliably estimated or are not considered probable at the current time. For more details of all the outstanding legal proceedings including those that have been deemed contingent, see Item 8. Financial Statements—Audited Consolidated Financial Statements - Note 16. Commitments and Contingencies.

Current wording

Litigation, arbitration and other legal proceedings against the Company may relate to compliance and trade practices, commercial claims, product liability claims, intellectual property rights, and employment and wrongful discharge claims. For each claim or grouping of similar claims, management makes judgments regarding the relative merits and risks within the claims. These judgments inform the Company’s defense strategies, whether a loss or settlement from the claims is probable and whether sufficient information exists to make a reliable estimate of the likely outcome of the claims. Provisions are recognized when it is probable that a liability will be incurred, and the amount of the loss can be reasonably estimated. Management has assessed as “contingent” matters that cannot be reliably estimated or are not considered probable at the current time. For more details of all the outstanding legal proceedings including those that have been deemed contingent, see Item 8. Financial Statements—Audited Consolidated Financial Statements - Note 16. Commitments and Contingencies.
Rearranged previous paragraphs (5)

Previous report — wording carried elsewhere

Comparison of the years ended December 31, 2023 and December 31, 2022

Previous report — wording carried elsewhere

The following table shows the Company’s net revenue by major product line:

Previous report — wording carried elsewhere

We estimate provisions for rebates, discounts and returns based on contractual arrangements with customers or terms of the regulations and/or agreements applicable for transactions with healthcare authorities, and in some cases on assumptions about the attainment of targeted volumes. Werecognize returns, discounts, incentives and rebates in the period in which we recognize the underlying sales, as a reduction of gross revenues and as current liabilities on our Consolidated Balance Sheets under trade and other payables or reductions of accounts receivable. The outstanding amounts are affected by changes in gross sales, the provision for net product sales deductions and timing of payments/credits. Estimates, assumptions and judgements applied to determine the provision for rebates, discounts and returns are set out in Item 8. Financial Statements—Audited Consolidated Financial Statements - Note 2. Summary of Significant Accounting Policies.

Previous report — wording carried elsewhere

The following table provides a summary of activities with respect to accrued rebates and product returns, and prompt pay discounts for the years ended December 31, 2023 and 2022:

Previous report — wording carried elsewhere

Income tax benefit. Income tax benefit in 2023 was $20 million, resulting in an effective tax rate of 13.2%. The income tax benefit of $44 million in 2022 reflected an effective tax rate of 49.3% on the Company’s earnings for 2022.