INDV 10-K & 10-Q changes, risk factors and insider trading
Indivior Pharmaceuticals, Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1625297 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “We must comply with the terms and conditions of the Stipulated Order for Permanent Injunction and Equitable Monetary Relief with the U.S. Federal Trade Commission (“FTC”), along with a similar injunction with certain State Attorneys General related to certain product launches and applications for product approvals and we could be subject to criminal charges or penalties if we fail to comply.”
New heading “We are subject, directly or indirectly, to a variety of U.S. and international laws and regulations related to fraud and abuse, transparency, and privacy. Enforcement actions under such laws have increased in recent years. If we fail to comply, or have not fully complied, with such laws, we could face substantial penalties.”
New heading “Actual costs to exit various businesses may differ materially from our estimates.”
New heading “Our business strategy may involve future transactions that may harm the market price of our common stock or require us to seek additional funds, and such funding may not be available on commercially favorable terms or at all and may cause dilution to our existing stockholders. The issuance of additional common stock in connection with future acquisitions, any stock incentive or stock option plan, or otherwise, may dilute all other stock holdings.”
New heading “Tariffs on pharmaceutical products, and potential reciprocal responses by other countries, may adversely affect our revenues or profitability.”
New heading “Weakness in the economy, geopolitics, market trends, disruptions in our supply chain, uncertainty, and other conditions in the markets in which we operate, particularly in the U.S., may adversely affect our sales growth and results of operations.”
New heading “The Parent Company is a holding company with no business operations of its own and depends on its subsidiaries for cash, including in order to pay dividends or repurchase shares.”
New heading “We are subject to anti-takeover provisions in our certificate of incorporation and bylaws and under Delaware law that could delay or prevent an acquisition of our company, even if the acquisition would be beneficial to our stockholders.”
New heading “Provisions of our Note Purchase Agreement may deter or prevent an otherwise beneficial takeover attempt of us.”
New heading “Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information, and personal data.”
Removed heading “We receive substantial revenue from our key proprietary products and our success depends on our ability to successfully commercialize new products.”
Removed heading “Branded Products”
Removed heading “Generic Products”
Removed heading “We face additional risks as a manufacturer that manufactures pharmaceutical products for others and, in the future, for ourselves.”
Removed heading “If we fail to develop or acquire other new products or compounds for development, our business, prospects, results of operations and financial condition could be materially adversely affected.”
Removed heading “See also Item 1A. Risk Factors—“We receive substantial revenue from our key proprietary products and our success depends on our ability to successfully commercialize new products.””
Removed heading “We may not be able to protect our intellectual property rights throughout the world which could have an adverse effect on our business, results of operations and financial condition.”
Removed heading “We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.”
Removed heading “We are subject, directly or indirectly, to a variety of U.S. and international laws and regulations related to fraud and abuse and transparency. Enforcement actions under such laws have increased in recent years. If we fail to comply, or have not fully complied, with such laws, we could face substantial penalties.”
Removed heading “Recently proposed tariffs on pharmaceutical products, and potential reciprocal responses by other countries, may adversely affect our revenues or profitability.”
Removed heading “Weakness in the economy, geopolitics, market trends, disruptions in our supply chain, uncertainty and other conditions in the markets in which we operate, particularly in the U.S., may adversely affect the profitability and financial stability of our customers, and could negatively impact our sales growth and results of operations.”
Removed heading “We may not be able to generate sufficient cash to service all of our indebtedness and may be forced to take other actions to satisfy our obligations under our indebtedness.”
Removed heading “If a U.S. person is treated as owning at least 10% of our ordinary shares, such holder may be subject to adverse U.S. federal income tax consequences.”
Removed heading “Our ordinary shares are listed to trade on more than one stock exchange, and this may result in price variations.”
Removed heading “We face a number of risks associated resulting from the relocation of our primary listing.”
Removed heading “The rights afforded to our shareholders are governed by English law. Not all rights available to shareholders under U.S. law will be available to holders of our ordinary shares.”
Removed heading “Provisions of our Note Purchase Agreement and the U.K. City Code on Takeovers and Mergers may deter or prevent an otherwise beneficial takeover attempt of us.”
Removed heading “Our business strategy may involve future transactions that may harm the market price of our ordinary shares or require us to seek additional funds, and such funding may not be available on commercially favorable terms or at all and may cause dilution to our existing shareholders. The issuance of additional ordinary shares in connection with future acquisitions, any share incentive or share option plan, or otherwise, may dilute all other shareholdings.”
Removed heading “The Parent Company is a holding company with no business operations of its own and depends on its subsidiaries for cash, including in order to pay dividends or make share repurchases.”
Removed heading “We are subject to various risks related to the local and international nature of our business, including domestic and foreign laws, regulations, and standards. Failure to comply with such laws and regulations or the occurrence of unforeseen developments such as litigation could adversely affect our business.”
Removed heading “If we fail to maintain an effective system of internal control over financial reporting (“ICFR”), fail to comply with Section 404 of the Sarbanes-Oxley Act, or if we identify a material weakness, then we may not be able to accurately report our financial results or prevent fraud and, as a result, shareholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our ordinary shares and may cause other increases in operating costs.”
Removed heading “We are a foreign private issuer. Should we no longer qualify as a foreign private issuer in the future, we may incur significant additional expenses. Also, as a foreign private issuer, we are not subject to SEC proxy rules. As a foreign private issuer, we are permitted to follow certain home country corporate governance practices in lieu of certain requirements applicable to domestic U.S. issuers. This may afford less protection to holders of our ordinary shares.”
Removed heading “We have changed the financial reporting standards that we apply to our financial statements from IFRS to U.S. GAAP and, as a result, some of our financial data may not be easily comparable to historical financial results.”
Removed heading “The obligations associated with being a company publicly traded in the U.S. require significant resources and management attention, and changing laws, regulations and standards are creating uncertainty for U.S. public companies.”
Largest changes
“The CIA imposes significant compliance obligations on Indivior Inc.’s business and practices and requires Indivior Inc. to engage an Independent Review Organization and a Board Compliance Expert (in CIA years 1 and 3) to assess Indivior Inc.’s compliance program. The CIA also sets forth monetary penalties that may be imposed on a per-day basis for failure to comply with certain obligations in the CIA. The CIA requires procedures under which Indivior Inc. must notify HHS-OIG of certain reportable events, and must notify HHS-OIG if it fails to meet the requirements under the CIA. …”see in full comparison
“We have mechanisms in place to procure compliance with rules and regulations, and applicable self-regulatory industry codes by region that the Company has committed to follow. However, there can be no assurance that our policies and procedures will be followed at all times or will effectively detect and/or prevent violations of applicable compliance regimes by our employees and other relevant persons. Nevertheless, previously, we were subject to enforcement actions by the U.S. Department of Justice and the Federal Trade Commission. …”see in full comparison
“We are subject to extensive federal, state and foreign healthcare laws regulation governing the development, manufacture, marketing, sale, and reimbursement of pharmaceutical products. As a pharmaceutical company that participates in government-regulated healthcare programs, we operate in a highly regulated environment in the United States, the European Union, and other jurisdictions where we do business. …”see in full comparison
“Companies operating in the pharmaceutical industry also face challenges to the validity or enforceability of listed patents and frequently agree to settlements of patent litigation. Regulatory authorities in the U.S. and Europe, including the FTC and the European Commission, increasingly scrutinize patent settlements. …”see in full comparison
“•In 2019, the U.S. Attorney’s Office for the Western District of Virginia brought an indictment, followed by a superseding indictment, against the Company in connection with our marketing and promotional practices related to SUBOXONE Film and SUBOXONE and SUBUTEX Tablets (the "2019 Indictment"). The indictment charged Indivior Inc. and Indivior PLC with health care fraud, mail fraud, wire fraud, and conspiracy to commit the same. …”see in full comparison
“•In 2019, the U.S. Attorney’s Office for the Western District of Virginia brought an indictment, followed by a superseding indictment, against the Company in connection with our marketing and promotional practices related to SUBOXONE Film and SUBOXONE and SUBUTEX Tablets (the "2019 Indictment"). The indictment charged Indivior Inc. and Indivior PLC with health care fraud, mail fraud, wire fraud, and conspiracy to commit the same. …”see in full comparison
Full comparison: every changed paragraph (431)
You should carefully consider the risks described below, together with all of the other information in this annual report on Form 10-K. The risks and uncertainties below are not the only ones we face. Additional risks and uncertainties not presently known to us or that we believe to be immaterial may also adversely affect our business. If any of the following risks occur, our business, financial condition, and results of operations could be seriously harmed, our stock price might decline, and you could lose all or part of your investment.
Risks Related to our Company and Its Business
•We are subject to risks related to the manufacture and distribution of our products and must adhere to stringent manufacturing practices.
•We rely heavily on SUBLOCADE for a significant portion of our revenues.
•Our revenues may grow at a slower than expected rate or decrease due to many factors.
•We are subject to substantial litigation and ongoing investigations and information requests.
•Our ability to generate revenues from our products is subject to attaining significant market acceptance.
•We are subject to litigation.
•We must comply with the terms and conditions of various government agreements.
•Compliance with legal and regulatory settlements requires significant resources and, if we fail to comply, we could be subject to penalties or excluded from government healthcare programs.
•Congress may reduce spending on Medicaid.
•We aredepend subjecton tothird-party riskspayors relatedfor toreimbursement the manufacture offor our products.
•Congress may reduce spending on Medicaid funding.
•We receive substantial revenue from a small number of key proprietary products.
•We depend on our ability to commercialize our products and acceptance of our products by physicians, patients, and healthcare payors.
•Several factors affect the rate at which our revenues may grow.
•Failure to retain key personnel or attract new personnel could have a material adverse effect on us.
•We are subject to a variety of laws and regulations related to fraud and abuse and transparency.
•Actual costs to exit various businesses may differ materially from our estimates.
•Our product pipeline relies on collaborations with third parties.
•We rely on some third parties to develop our pharmaceutical pipeline and conduct clinical trials.
•We depend on third-party payors for reimbursement for our products.
•We face additional risks when we manufacture for others.
•We may fail to develop or acquire other new products or compounds.
•Failure to retain key personnel or attract new personnel could have an adverse effect on us.
•We may not be able to protect our intellectual property rights throughout the world.
•Our employees may wrongfully use or disclose alleged trade secrets of their former employers.
•We are subject to ongoing obligations and continued regulatory inspection.
•Failure to comply with anti-corruption laws and regulations, anti-money laundering laws and regulations, and/or economic sanctions could result in us becoming subject to fines or penalties.
•We are subject to healthcare fraud and abuse, transparency, and false claims laws.
•We are subject to anti-corruption laws and regulations.
•RecentlyOur proposedbalance tariffssheet onis pharmaceutical products,leveraged, and potentialany reciprocalreduction responsesin by other countries,revenue may adversely affect our revenuesliquidity orand profitability.
•Our business strategy may involve transactions which may dilute existing stockholders’ interests.
•Our effective tax rate may increase.
•Tariffs on pharmaceutical products may adversely affect our revenues or profitability.
•Our operating results may fluctuate significantly.
•Any reduction in annual sales may adversely affect our liquidity.
•TheAny recentfuture pandemicpandemic, and governmental and societal responses theretothereto, havemay adversely affectedharm our businessbusiness, results of operations, and mayfinancial continue to do so.condition.
•Our $350 million term loan contains covenants that could limit our ability to plan for or respond to changes in our business.
•We may not be able to generate sufficient cash to service all of our indebtedness.
•Our effective tax rate may increase, and changes in tax rules and regulations, or interpretations thereof, may adversely affect our financial condition.
•If a U.S. person is treated as owning at least 10% of our ordinary shares, such holder may be subject to adverse U.S. federal income tax consequences.
Risks Related to Our OrdinaryCommon SharesStock
•Our ordinarycommon sharesstock areis subject to market price volatility.
•Our ordinary shares are listed to trade on more than one stock exchange, and this may result in price variations.
•The rights afforded to our shareholders are governed by English law.
•Provisions of our Note Purchase Agreement and the U.K. City Code on Takeovers and Mergers may delay or prevent an otherwise beneficial takeover attempt of us.
•Our business strategy may involve transactions which may dilute existing shareholders’ interests.
•The Parent Company is a holding company with no business operations of its own and depends on its subsidiaries for cash, including in order to pay dividends or make share repurchases.
•We are subject to anti-takeover provisions in our certificate of incorporation, bylaws, and Note Purchase Agreement that could delay or prevent an acquisition of our company.
•We are a holding company with no business operations of our own and depend on our subsidiaries for cash, including in order to pay dividends.
•Artificial intelligence presents risks and challenges that can impact our business including posing security risks to our confidential information, proprietary information, and personal data.
•We are subject to various risks related to the local and international nature of our business.
Risks Related to Being a Publicly TradedPublicly-Traded Company in the U.S.
•We may fail to maintain effective internal controls over financial reporting.
•We are a foreign private issuer and expect to lose our foreign private issuer status in the future.
•We have changed to U.S. generally accepted accounting principles.
•The obligations associated with being a public company in the U.S. are significant.
All facilities and manufacturing techniques used for the manufacture of our products must be operated in conformity with the mandatory manufacturing standards (often referred to as current good manufacturing practice (cGMP)) of the FDA, Health Canada, the Australian Therapeutic Goods Administration, and other regulatory authorities. Manufacturing facilities are subject to periodic unannounced inspections by the FDA, MHRA, HPRA, and other regulatory authorities. Failure to comply with applicable legal and regulatory requirements, and with the manufacturing details filed as part of our marketing authorization, subjects our manufacturing facilities or the facilities of our third-party manufacturers to possible legal or regulatory action, such as inspectional observations (e.g., Form FDA 483 notices), warning letters, suspension of manufacturing, product seizure, withdrawal of the product from the market, administrative, civil and criminal penalties, among other enforcement remedies. Therefore, such enforcement actions may adversely affect our ability to manufacture, or our third-party suppliers’ ability to supply, finished products.
We have been, and may in the future become, involved in various legal proceedings, regulatory proceedings, and government enforcement actions. Such proceedings may include claims for, or the possibility of, damages or fines and penalties involving substantial amounts of money or other relief, including but not limited to civil or criminal fines and penalties. For example:
Management's Discussion & Analysis (MD&A)
New heading “Corporate Initiatives”
New heading “U.S. net revenue”
New heading “Rest of World net revenue”
New heading “Selling, general and administrative expenses”
New heading “Research and development expenses”
New heading “Acquired in-process research and development expenses”
New heading “Litigation settlement expenses”
New heading “Other operating (income) expense, net”
New heading “Net interest expense”
New heading “Income tax expense”
Removed heading “Discontinuation of marketing and promotion of PERSERIS (2024)”
Removed heading “Asset Acquisitions and Business Combinations (2023)”
Removed heading “Comparison of the years ended December 31, 2023 and December 31, 2022”
Removed heading “Selected Quarterly Financial Data (Unaudited)”
Largest changes
“Net cash used in operating activities was $300 million in 2023 an increase of $296 million compared to the net cash used of $4 million in 2022. The additional outflow was primarily due to litigation settlement payments of $610 million, partially offset by increased accruals for government rebates and trade payables. …”see in full comparison
Net cash used in operating activities was $27 million in 2025, a decrease of $63 million, compared to net cash provided by operating activitiessee in full comparisonwasof $36 million in2024,2024.anTheincreasedecreaseofwas$336drivenmillion,bycompared to net cash used in operating activities of $300$208 millionin 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 scheduledhigher litigation settlement payments in 2025, including the optional prepayment of$173themillion.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 onthelitigation-related settlement payments.
“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. …”see in full comparison
“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. …”see in full comparison
“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.”see in full comparison
Full comparison: every changed paragraph (132)
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.
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.
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.
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.
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.
(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.
For the periods presented, theThe Company operatedoperates 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.disorders. Substantially all our net revenue for such2025 periodsand were2024 was derived from sales of SUBLOCADE and other buprenorphine-based sublingual products (including SUBOXONE Film and SUBOXONE Tablet). SUBLOCADE accounted for 64%, 58%,69% and 45%64% of our net revenue in 2024, 2023,2025 and 2022,2024, respectively. Other buprenorphine-based sublingual products accounted for 32%, 38%,28% and 52%32% of our net revenue in 2024, 2023,2025 and 2022,2024, 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.
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.
Our net revenue is impactedaffected by thepatient overall growth of the markets where we operate. Market growth is impacted by increased treatment penetration, which is a function ofawareness, patient awareness and desirewillingness to seek treatment, as well asand the number of certifiedeligible physicianshealthcare providers available to deliveradminister treatment. Competitive pressuresdynamics canmay driveexert pricing pressure and canmay also influenceaffect decisions ofby third-partythird‑party payors regarding inclusionformulary ofplacement productsand onreimbursement their list of approved drugs covered by insurance.coverage. To increasesupport accessincreased topatient treatment for patients,access, we engage with governmentgovernmental agencies, key opinion leaders in addiction medicine, and healthcare professionals to bringinform policy development and highlight 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.outcomes.
In 2024, the volume of2025, U.S. buprenorphine medication-assistedmedication‑assisted treatmentstreatment (BMAT) grewvolume incontinued mid-singleto digits.grow Marketat growtha wasmid‑single‑digit 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.rate. The Company continues to expect long-termlong‑term U.S. BMAT market growth to beremain sustained inwithin the mid- to high-single mid‑single‑digit percentage rangerange, due to increased overallreflecting public awareness of the opioid epidemic and approved treatments, togetheras withwell as regulatory and legislative actions intended to increaseexpand access to BMAT treatments.therapies. InThe 2024,U.S. long‑acting injectable (LAI) segment grew in the Company'shigh‑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 marketLAI growthsegment washas impacted by both competitionstabilized in the LAImid‑seventy category,percent whichrange. weThe expectCompany expects to continue,continue asinvesting wellat assustained competitionlevels into thesupport oralfurther category.LAI penetration by increasing patient awareness and advancing policies designed to improve patient access to treatment.
In the U.S., we have distribution agreements with the three largest wholesalers, which accounted for 55%, 54%,51% and 55% of our global net revenue in 2024, 2023,2025 and 2022,2024, respectively. These wholesalers, in turn, distribute our products through various channels including the following:
•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 administeredregulated and funded by the U.S. government.government generally for senior citizens and administered by private insurance companies.
•Pharmacy. This channel covers end customersend-customers paying cash directly at the pharmacy. Often, we provide discount coupons to customers wherewho cashbuy isour usedproducts forwithout payment.pharmaceutical benefit coverage.
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.
In the MostRest of World, distribution channels differ by country.country For example, in France,and we may engage with different wholesalers, pre-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.individuals.
•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.
•Chargebacks. Discounts thatare occurprovided 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.
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.
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.
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 Policies, Note 11. Accrued Litigation Settlement Expenses and Note 16. Commitments and Contingencies.
Discontinuation of marketing and promotion of PERSERIS (2024)
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.
Asset Acquisitions and Business Combinations (2023)
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.
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.
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.
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.
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.
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.
See Item 8. Financial Statements—Audited Consolidated Financial Statements - Note 18. Asset Acquisitions and Note 19. Business Combinations for more information on these transactions.
Corporate Initiatives
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.
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.
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.
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.
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.
________________ (1)See Item 8. Financial Statements—Audited Consolidated Financial Statements—Note 11. Accrued Litigation Settlement Expenses.
Net revenue
Net revenue. Our 20242025 and 20232024 net revenue was driven by sales of SUBLOCADESUBLOCADE. In 2025 and other buprenorphine-based sublingual products (including SUBOXONE Film and SUBOXONE Tablet). In 2024 and 2023,2024, SUBLOCADE accounted for 64%69% and 58%64% of our net revenue, other buprenorphine-based sublingual products accounted for 32%28% and 38%,32%, and PERSERIS accounted for 3%2% and 4%,3%, 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.
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 category and 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.
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.
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.
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.
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.
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.”
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, 2024 and 2023:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Comparison of the years ended December 31, 2023 and December 31, 2022
(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.
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.
The following table shows the Company’s net revenue by major product line:
What changed in the latest 10-Q
Risk Factors
New heading “Risks Related to the Pending Merger with Supernus”
New heading “The merger is subject to conditions, some or all of which may not be satisfied, or completed on a timely basis, if at all. Failure to complete the merger could have material adverse effects on our business.”
New heading “The exchange ratio is fixed and will not be adjusted in the event of any change in either Indivior’s or Supernus’s stock price.”
New heading “Each party is subject to business uncertainties and contractual restrictions while the merger is pending, which could adversely affect each party’s business and operations.”
New heading “Following the merger, the composition of the combined company board of directors will be different than the composition of the current Indivior Board or the current Supernus Board.”
New heading “Even if we complete our proposed merger with Supernus, we may fail to realize the anticipated benefits.”
Largest changes
“The merger is subject to conditions, some or all of which may not be satisfied, or completed on a timely basis, if at all. Failure to complete the merger could have material adverse effects on our business.”see in full comparison
“Following the merger, the composition of the combined company board of directors will be different than the composition of the current Indivior Board or the current Supernus Board.”see in full comparison
“Each party is subject to business uncertainties and contractual restrictions while the merger is pending, which could adversely affect each party’s business and operations.”see in full comparison
“The exchange ratio is fixed and will not be adjusted in the event of any change in either Indivior’s or Supernus’s stock price.”see in full comparison
“Even if we complete our proposed merger with Supernus, we may fail to realize the anticipated benefits.”see in full comparison
Full comparison: every changed paragraph (23)
In addition to the other information set forth in this Quarterly Report on Form 10-Q, the reader should carefully consider the factors discussed in Part I, “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025. There have been no material changes in the Company's risk factors from those disclosed in Part I, Item 1A, of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 20252025, withas updated by Part II, Item 1A, Risk Factors, of the exceptionCompany’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2026, except that we add the following risk factors are removedfactor: “Our term loan contains covenants that limit our ability to plan for or respond to changes in our business,” and “Clinical trials for the development of products may be unsuccessful.”
Risks Related to the Pending Merger with Supernus
The merger is subject to conditions, some or all of which may not be satisfied, or completed on a timely basis, if at all. Failure to complete the merger could have material adverse effects on our business.
The completion of the merger is subject to a number of conditions, including, among other things, the receipt of the Indivior stockholder approval and the Supernus stockholder approval and receipt of certain regulatory approvals, which make the completion and timing of the merger uncertain. The failure to satisfy all of the required conditions could delay the completion of the merger for a significant period of time or prevent it from occurring at all. There can be no assurance that the conditions to the completion of the merger will be satisfied or waived or that the merger will be completed.
If the merger is not completed, we may be materially adversely affected and, without realizing any of the benefits of having completed the merger, will be subject to a number of risks, including the following:
•the market price of our common stock could decline;
•We could owe a substantial termination fee to Supernus party in specified circumstances;
•time and resources, financial and other, committed by our management to matters relating to the merger could otherwise have been devoted to pursuing other beneficial opportunities;
•we may experience negative reactions from the financial markets or from its customers, suppliers or employees; and
•we will be required to pay its costs relating to the merger, such as legal, accounting, financial advisory and printing fees, whether or not the merger is completed.
In addition, if the merger is not completed, we could be subject to litigation related to any failure to complete the merger or related to any enforcement proceeding commenced against us to perform its obligations under the merger agreement. Any of these risks could materially and adversely impact our ongoing business, financial condition, financial results and stock price.
Similarly, delays in the completion of the merger could, among other things, result in additional transaction costs, loss of revenue or other negative effects associated with delay and uncertainty about completion of the merger and could materially and adversely impact our ongoing business, financial condition, financial results and stock price following the completion of the merger.
The exchange ratio is fixed and will not be adjusted in the event of any change in either Indivior’s or Supernus’s stock price.
Upon completion of the merger, each issued and outstanding share of Supernus common stock will be converted into the right to receive the merger consideration, which is equal to 1.5401 shares of Indivior common stock. This exchange ratio was fixed in the merger agreement and will not be adjusted for changes in the market price of either Indivior common stock or Supernus common stock.
It is impossible to accurately predict the market price of Indivior common stock at the completion of the merger and, therefore, impossible to accurately predict the market value of the shares of Indivior common stock that Supernus stockholders will receive in the merger. The market price for Indivior common stock or Supernus common stock may fluctuate both prior to the completion of the merger and thereafter for a variety of reasons, including, among others, general market and economic conditions, the demand for Indivior’s or Supernus’s products, changes in laws and regulations, other changes in Indivior’s and Supernus’s respective businesses, operations, prospects and financial results of operations, market assessments of the likelihood that the merger will be completed, and the expected timing of the merger. Many of these factors are beyond our control. As a result, the market value represented by the exchange ratio will also vary.
Each party is subject to business uncertainties and contractual restrictions while the merger is pending, which could adversely affect each party’s business and operations.
In connection with the pendency of the merger, it is possible that some customers, suppliers and other persons with whom we have a business relationship may delay or defer certain business decisions or might decide to seek to terminate, change or renegotiate their relationships with us, as the case may be, as a result of the merger or otherwise, which could negatively affect our revenues, earnings and/or cash flows, as well as the market price of our common stock, regardless of whether the merger is completed.
Under the terms of the merger agreement, each of Indivior and Supernus is subject to certain restrictions on the conduct of its business prior to completing the merger, which may adversely affect our ability to execute certain of its business strategies, including the ability in certain cases to modify or terminate contracts, acquire or dispose of assets, incur indebtedness, pay dividends, incur capital expenditures or settle claims. Such limitations could adversely affect our business and operations prior to the completion of the merger.
Each of the risks described above may be exacerbated by delays or other adverse developments with respect to the completion of the merger.
Following the merger, the composition of the combined company board of directors will be different than the composition of the current Indivior Board or the current Supernus Board.
Upon completion of the merger, the board of directors of the combined company will consist of eight directors, including four directors designated by Indivior and four directors designated by Supernus. This new composition of the board of directors of the combined company may affect the future decisions of the combined company.
Even if we complete our proposed merger with Supernus, we may fail to realize the anticipated benefits.
No assurance can be given that the anticipated benefits, synergies, growth, profitability, cash flow generation and earnings accretion of the Merger will be realized or, if realized, may be realized more slowly than expected. Further, inherent in transactions such as these are the risks relating to the integration of the two businesses.
Management's Discussion & Analysis (MD&A)
Removed heading “Research & Development Pipeline Updates”
Removed heading “Trend Information”
Largest changes
“Cost of sales. Cost of sales decreased $2 million, or 3%, and $6 million, or 6%, in the three and six months ended June 30, 2026 as compared to the same periods of 2025. The decrease was primarily attributable to a prior-year $10 million SUBLOCADE inventory write-down in the three and six months of 2025. For the year-to-date period, cost of sales reflected a benefit of approximately $5 million related to revenue recognized on inventory fully written down in prior periods with no associated cost of sales in the current year. …”see in full comparison
Research and development expenses. Research and development expenses decreased bysee in full comparison$6$9 million, or28%,42%, and $15 million, or 35%, in the three and six months endedMarchJune31,30, 2026 as compared to the sameperiodperiods of 2025. Research and development expenses in the three and six months endedMarchJune31,30, 2026 includedthe impact of $7$6 million and $14 million, respectively, of real estate consolidationcostsandrelatedseveranceto the Indivior Action Agenda.costs. Excluding these impacts, lower research and development costs in the three and six months endedMarchJune31,30, 2026primarilyreflectedreflectreducedreprioritizationresearch and development activities and decisions earlier in the year to cease Phase 3 development of INDV-6001 and not advance INDV-2000 internally. The Company is not currently pursuing any pipeline activities and, as a result, research andrestructuringdevelopmentbenefitscostsassociatedarewithexpectedthetoIndiviorcontinueActiontoAgenda.decrease in future periods.
“During the three months ended March 31, 2026, the Company incurred $14 million of costs associated with the Indivior Action Agenda, primarily related to severance, real estate impairment, and consulting, legal and tax expenses. The Company has entered Phase II - Accelerate of the Action Agenda, which is designed to accelerate SUBLOCADE dispense unit growth, net revenue and grow cash flow at an even faster rate in 2026.”see in full comparison
“On August 1, 2026, the Company entered into an Agreement and Plan of Merger with Supernus. Pursuant to the Merger Agreement, and subject to approval of Indivior stockholders and Supernus stockholders and the satisfaction or waiver of other specified closing conditions, the Indivior and Supernus businesses will combine in an all-stock merger of equals. …”see in full comparison
Full comparison: every changed paragraph (39)
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.OUD. Substantially all of 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 73%74% and 66%74% of our net revenue for the three and six months ended MarchJune 31,30, 20262026, respectively, and 69% and 68% for the three and six months ended June 30, 2025, respectively. Other buprenorphine-based sublingual products accounted for 25% and 32%25% of our net revenue for the three and six months ended MarchJune 31,30, 2026 and 27% and 29% of our net revenue for the three and six months ended June 30, 2025, respectively. SUBOXONE Film had an oral buprenorphine medically assisted treatment (BMAT) average share of approximately 14% and 15% in the three months ended MarchJune 31,30, 2026 and 2025, respectively, according to data from Symphony Health.
On August 1, 2026, the Company entered into an Agreement and Plan of Merger with Supernus. Pursuant to the Merger Agreement, and subject to approval of Indivior stockholders and Supernus stockholders and the satisfaction or waiver of other specified closing conditions, the Indivior and Supernus businesses will combine in an all-stock merger of equals. The Merger Agreement provides that, upon the terms and subject to the conditions set forth in the Merger Agreement, the Company's wholly-owned subsidiary will merge with and into Supernus, with Supernus continuing as a wholly-owned subsidiary of Indivior (which will change its name to Supernus, Inc.) following the transaction. We expect the transaction to close during the fourth quarter of 2026. For additional discussion of this matter, see Note 15. Subsequent Events.
During the six months ended June 30, 2026, Indivior made the decision to cease Phase 3 development of INDV-6001 and not advance INDV-2000 internally. The Company is not currently pursuing any pipeline activities.
Corporate initiatives during the three months ended June 30, 2026 included the recognition of severance of approximately $6 million, including approximately $5 million associated with the decisions not to advance the two research and development pipeline programs.
During the three months ended March 31, 2026, the Company incurred $14 million of costs associated with the Indivior Action Agenda, primarily related to severance, real estate impairment, and consulting, legal and tax expenses. The Company has entered Phase II - Accelerate of the Action Agenda, which is designed to accelerate SUBLOCADE dispense unit growth, net revenue and grow cash flow at an even faster rate in 2026.
In February 2026, the Company announced a share repurchase program of up to $400 million with a term of up to 18 months. InDuring the three months ended March 31, 2026, the Company repurchased 3,974,153 shares wereof repurchasedits common stock at an average price of $31.45 per share for atotal totalconsideration of $125 million. During the three months ended June 30, 2026, the Company repurchased 4,664,540 shares of its common stock at an average price of $37.52 for total consideration of $175 million. Indivior has $275$100 million remaining under the share repurchase program which it intends to utilize opportunistically.
During the three months ended March 31, 2026, the Company successfully completed a $500 million offering of 0.625% convertible senior notes due in 2031 which included an option to purchase up to an additional $50 million aggregate principal amount of the Notes granted to the initial purchasers, which was exercised in full. A portion of the $500 million proceeds was used to repay in full the $333 million balance of Indivior's original term loan.
For a discussion of recent developments with respect to litigation, see NoteItem 12.1. Financial Statements--Note 13. Commitments and Contingencies.
Research & Development Pipeline Updates
INDV-6001 (Buprenorphine Caproate): Indivior does not intend to pursue Phase 3 development of INDV-6001 and has amended its license agreement with Alar Pharmaceuticals. Pursuant to the amendment, Alar will regain development rights to the asset and will have commercialization rights outside the U.S. Indivior will maintain exclusive commercial rights in the U.S. should Alar receive FDA approval for a commercially viable product in the future.
INDV-2000 (Rocavorexant): INDV-2000 did not meet the primary endpoint of "no treatment failure.” Following a topline evaluation of the Phase 2 proof-of-concept study data, Indivior will not be advancing INDV-2000 internally as a treatment for opioid use disorder.
However, Indivior will pursue a business development opportunity with third parties. Importantly, prospectively planned sensitivity analyses, together with converging supportive findings, identified a credible and biologically coherent signal at the 200-milligram dose. Indivior intends to continue to strengthen the data package through additional analyses, including exposure-response work and further evaluation of supportive clinical and mechanistic findings. Study findings included directional effects on polysubstance use abstinence, exploratory anxiety outcomes, and fMRI evidence consistent with modulation of relapse-related neural circuitry. INDV-2000 also demonstrated a favorable safety and tolerability profile consistent with findings from previous studies.
Net revenue growth for the three and six months ended MarchJune 31,30, 2026 as compared to the same periodperiods of 2025 was primarily driven by sales of SUBLOCADE in the U.S.
Total net revenue increased by $51$41 million, or 19%,14%, and $92 million, or 16%, in the three and six months ended June 30, 2026, respectively, as compared to the same periods of 2025. U.S. net revenue increased by $50$45 million, or 22%,17%, and $95 million, or 20%, in the three and six months ended MarchJune 31,30, 20262026, respectively, as compared to the same periodperiods of 2025.
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 $54$42 million, or 33%,22%, and $97 million, or 27%, in the three and six months ended MarchJune 31,30, 2026, respectively, as compared to the same periodperiods inof 2025,2025. The increases were driven by dispense unit volume growthgrowth, ofgross-to-net 20%benefits and favorable price mix.mix in both periods. Dispense unit volume grew 18% and 19% in the three and six months ended June 30, 2026, respectively, as compared to the corresponding 2025 periods. U.S. net revenue from other products declinedincreased $4by $2 million in the three months ended MarchJune 31,30, 2026, reflectingand lowerdecreased categoryby share$2 million in the U.S.six formonths SUBOXONEended Film,June partially30, 2026, compared with the same periods of 2025. Both periods benefited from favorable Film gross-to-net adjustments, offset by favorablea gross-to-netdecline adjustments.in U.S. Film category share.
Rest of the World net revenue. In the three and six months ended MarchJune 31,30, 2026, net revenue attributable to Rest of the World ofdecreased $45by $3 million increasedand by$2 $1million, millionrespectively, as compared to the same period in 2025. Restperiods of World2025, net revenues recorded inreflecting the threeexit monthsfrom endedcertain Marchnon-U.S. 31,markets, 2026and includedwe approximatelyexpect $5this million of revenues relatedtrend to Rest of World market exits that are not expected to recur at this level in future periods.continue.
The following table provides a summary of activities with respect to accrued rebates and product returns and prompt pay discounts for the threesix months ended MarchJune 31,30, 2026 and 2025:
Accrued rebates and product returns include chargebacks as these are paid by Indivior. Prompt pay discounts are recorded as offsets to accounts receivable. Accrued rebates and product returns and prompt pay discounts decreased to $555$613 million as of MarchJune 31,30, 20262026, from $678$712 million as of MarchJune 31,30, 2025, primarily drivendue byto the timing of rebate invoicing and payments. Specifically, Accrued rebates and product returns and prompt pay discounts were higher in the priorprior-year period ending MarchJune 31,30, 2025, primarily asdue ato resultthe timing of a delay in payment of approximately $100 million of government rebates dueresulting tofrom the late receipt and processing of invoices.
Cost of sales. Cost of sales decreased $2 million, or 3%, and $6 million, or 6%, in the three and six months ended June 30, 2026 as compared to the same periods of 2025. The decrease was primarily attributable to a prior-year $10 million SUBLOCADE inventory write-down in the three and six months of 2025. For the year-to-date period, cost of sales reflected a benefit of approximately $5 million related to revenue recognized on inventory fully written down in prior periods with no associated cost of sales in the current year. These favorable impacts were partially offset by approximately $2 million of inventory provisions recorded in the three and six months ended June 30, 2026 related to market exit activities, and the effect of SUBLOCADE growth.
Cost of sales. Cost of sales decreased $4 million, or 10%, in the three months ended March 31, 2026 as compared to the same period of 2025. The decrease was primarily driven by approximately $5 million of SUBLOCADE revenues recognized in the first quarter of 2026 with no corresponding cost of sales, as the related inventory had been fully written down in prior periods.
Gross margin, which we define as gross profit divided by net revenue, was 87%85% and 86% in the three and six months ended MarchJune 31,30, 2026, respectively, as compared to 83% and 83% in the samecorresponding periodperiods of 2025. The changesincreases in gross margin were primarily driven by theSUBLOCADE volume growth in SUBLOCADE volume, channel mix, and thelower benefitcost of changessales inas estimatedescribed related to rebate accruals.above.
Selling, general and administrative expenses. Selling, general and administrative expenses decreased by $9$36 million, or 7%,23%, and $46 million, or 16%, in the three and six months ended MarchJune 31,30, 20262026, respectively, as compared to the same periodperiods of 2025. The overall decrease in selling,Selling, general and administrative expenses included consulting, severance and other costs associated with corporate initiatives of $4 million in each of the three month periods ended June 30, 2026 and 2025, and $10 million and $5 million in the six month periods ended June 30, 2026 and 2025, respectively. The overall decrease was primarily driven by headcount reductions and other cost savings related to thecorporate Indiviorinitiatives Action Agenda, partly offset by investmentsimplemented in U.S.2025 SUBLOCADEand marketing.2026.
Research and development expenses. Research and development expenses decreased by $6$9 million, or 28%,42%, and $15 million, or 35%, in the three and six months ended MarchJune 31,30, 2026 as compared to the same periodperiods of 2025. Research and development expenses in the three and six months ended MarchJune 31,30, 2026 included the impact of $7$6 million and $14 million, respectively, of real estate consolidation costsand relatedseverance to the Indivior Action Agenda.costs. Excluding these impacts, lower research and development costs in the three and six months ended MarchJune 31,30, 2026 primarilyreflected reflectreduced reprioritizationresearch and development activities and decisions earlier in the year to cease Phase 3 development of INDV-6001 and not advance INDV-2000 internally. The Company is not currently pursuing any pipeline activities and, as a result, research and restructuringdevelopment benefitscosts associatedare withexpected theto Indiviorcontinue Actionto Agenda.decrease in future periods.
As discussed in the Research & Development Pipeline Updates section above, the Company does not intend to pursue Phase 3 development of INDV-6001 and also will not be advancing INDV-2000 internally. As a result, Research and development activities are expected to decrease in future periods.
Loss on extinguishment of debt. Loss on extinguishment of debt in the threesix months ended MarchJune 31,30, 2026 includes $18 million of costs incurred in connection with the full repayment of the Company's Note Purchase Agreement.
Net interest (income) expense. Net interest expenseincome was $4$1 million infor the three months ended MarchJune 31,30, 2026 and net interest expense was $3 million for the six months ended June 30, 2026 as compared to net interest expense of $7$10 million inand $17 million for the three and six months ended MarchJune 31,30, 2025. The decreasechange in interest expenseprimarily reflects the lower interest cost of the Convertible Notes compared to the Company's previous Note Purchase Agreement.
Income tax expense. On January 26, 2026, the Company completed a redomiciliation to the United States, which resulted in a change in the applicable federal statutory income tax rate from 25% to 21%. Income tax expense of $26$38 million and $65 million in the three and six months ended MarchJune 31,30, 2026 resulted in an effective tax rate of 24% and 23%, respectively, primarily driven by a U.K. global minimum top-up tax, disallowed expenses, and a write-off of U.K. Net Operating Losses, partially offset by U.K. innovation deductions. Income tax expense of $11$44 million and $56 million in the three and six months ended MarchJune 31,30, 2025,2025 resulted in an effective tax rate of 19%,71% and 46%, respectively, primarily driven by benefitsa fromtax reserve on a U.K. HMRC settlement which became probable during the quarter, U.K. global minimum top-up tax, share based compensation shortfall tax expense and a valuation allowance against corporate interest limitation carryforwards, partially offset by U.K. innovation deductions and intragroup financing transactions, partially offset by a U.K. global minimum top-up tax and stock-based compensation shortfall tax expense.transactions.
Net cash used in operating activities was $9 million during the three months ended March 31, 2026, compared to net cash provided by operating activities ofwas $75$220 million during the six months ended June 30, 2026, compared to $233 million in the same period of 2025, a decrease of $84$13 million. Net cash usedprovided inby operating activities in the threesix months ended MarchJune 31,30, 2026 was driven primarily reflectedby cash generated from operations, partially offset by litigation settlement payments of $34 million and the timing of tax and operational payments, partly driven by streamlining actions taken under the Indivior Action agenda, including the Rest of World optimization. These uses of cash were partially offset by cash generated from operations.payments. Net cash provided by operating activities in the threesix months endingended MarchJune 31,30, 2025 reflected cash generated from operations and also benefited from the timing of receipt of approximately $100$120 million in government rebate invoices,invoices that were unpaid at June 30, 2025, partially offset by $65 million in litigation settlement payments.
Net cash used in investing activities was $19$27 million and $5$22 million in the threesix months ended MarchJune 31,30, 2026 and 2025, respectively, an increase of $14$4 million. The change ismillion driven primarily by an increase inhigher capital expenditures related to the new Raleigh, North Carolina manufacturing facility in the threesix months ended MarchJune 31,30, 2026 compared to the threesix months ended MarchJune 31,30, 2025, and was primarily related to construction of the Company’s new wholly-owned manufacturing facility for SUBLOCADE located in Raleigh, North Carolina.2025.
WeAn expectadditional approximately $20$10 million to $30$15 million of capital expenditures forare expected in the fullsecond yearhalf of 2026, primarily related to the Raleigh, North Carolina manufacturing facility.
Net cash provided by financing activities in the three months ended March 31, 2026 was $7 million, as compared to cash used in financing activities ofin $17the six months ended June 30, 2026 was $166 million, as compared to $22 million in the same period of 2025. The change was primarily reflectsdriven by higher cash outflows for shares repurchased and canceled of $292 million, partially offset by $151 million of net cash inflows related to the issuance of the Convertible Notes and payoff in full of the previous term loan in the threesix months ended MarchJune 31,30, 2026, partly offset by higher cash outflows for shares repurchased and canceled of $115 million as well as cash outflows for the settlement of tax on equity awards.2026.
During the threesix months ended MarchJune 31,30, 2026, the Company successfully completed a $500 million offering of 0.625% convertibleConvertible seniorSenior notesNotes due in 2031 which included an option to purchase up to an additional $50 million aggregate principal amount of the Notes granted to the initial purchasers, which was exercised in full.2031. A portion of the $500 million proceeds was used to repay in full the $333 million balance of Indivior's original term loan. See Item 1. Financial Statements—Note 8. Debt for more details.
During the threesix months ended MarchJune 31,30, 2026, the Company announced a $400 million share repurchase program and purchased approximately 4 million8,638,693 shares for total cash outflows of $125$300 million. The program runs through mid-2027.
In connection with the Merger Agreement and the special dividend, Indivior entered into a commitment letter with Citibank, N.A. pursuant to which Citibank, N.A. has committed to provide, subject to the terms and conditions thereof, a senior secured term loan facility in an aggregate principal amount of $650 million. For additional discussion of this matter, see Note 15. Subsequent Events.
Purchases of property and equipment were $27 million and $22 million for the six months ended June 30, 2026 and 2025, respectively. The Company’s capital expenditures primarily reflect investments in the new Raleigh, North Carolina manufacturing facility for SUBLOCADE.
Our contractual obligations as of MarchJune 31,30, 2026 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, 2025. WithSince theDecember exception31, of2025, thesignificant impactschanges onto theour timingcontractual andobligations amounts of debt repayments followinginclude the issuance of the 2031 Convertible Senior Notes that mature in 2031 and repayment of debt under the Note Purchase Agreement, nowhich materialaltered changesthe timing and amounts of future debt repayments. Additionally, corporate initiatives undertaken during the six months ended June 30, 2026 resulted in lower lease obligations due to ourreal contractualestate consolidation and increased employee-related obligations haveassociated occurredwith beyondadditional theworkforce ordinaryreductions, coursemost of businesswhich aswill ofbe Marchsettled 31,within 2026.one year.
Trend Information
For a discussion of trend information, see “Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Operating Results.”
Our significant accounting policies, which include management’s estimates and judgments, are included in "Item 1. Financial Statements - Note 2 Summary of Significant Accounting Policies" of our Annual Report on Form 10-K for the year ended December 31, 2025. No significant changes to our accounting policies occurred during the quarter ended MarchJune 31,30, 2026. A discussion of accounting estimates considered critical because of the potential for a significant impact on the financial statements due to the inherent uncertainty in such estimates is included in the Critical Accounting Estimates section of "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, 2025.
INDV insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 2 Form 4 filings (1 insider, 2 trade dates, 3,000 shares, about $108.0K) and open-market sales in 3 filings (2 insiders, 3 trade dates, 73,172 shares, about $2.8M; 3 of these filings say the sales were made under a Rule 10b5-1 trading plan). Net open-market shares: -70,172 (purchases minus sales); net value about -$2.7M.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-08-27 | Anderson Woodrow D |
Open-market purchase | 1,500 | $35.69 | $53.5K |
| 2026-08-05 | Anderson Woodrow D |
Open-market purchase | 1,500 | $36.28 | $54.4K |
| 2026-07-10 | Heidbreder Christian |
Open-market sale |
18,586 | $41.14 | $764.6K |
| 2026-06-22 | Ciaffoni Joseph |
Option exercise | 1,266,903 | — | — |
| 2026-06-22 | Ciaffoni Joseph |
Shares withheld for tax | 612,549 | $38.32 | $23.5M |
| 2026-06-11 | Heidbreder Christian |
Open-market sale |
18,586 | $38.06 | $707.4K |
| 2026-06-08 | Preblick Ryan |
Open-market sale |
36,000 | $37.70 | $1.4M |
| 2026-05-13 | Thompson Juliet |
Grant/award | 6,518 | — | — |
| 2026-05-13 | Humphreys Keith |
Grant/award | 6,518 | — | — |
| 2026-05-13 | Kingsley Stuart A |
Grant/award | 6,518 | — | — |
| 2026-05-13 | Ninivaggi Daniel A |
Grant/award | 6,518 | — | — |
| 2026-05-13 | Ryan Barbara |
Grant/award | 6,518 | — | — |
| 2026-05-13 | Stejbach Mark |
Grant/award | 6,518 | — | — |
| 2026-05-13 | Wheadon David E. |
Grant/award | 10,430 | — | — |
| 2026-05-12 | Thompson Juliet |
Shares withheld for tax | 1,117 | $38.28 | $42.8K |
Well-known investors holding INDV (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Oaktree Capital Management (Howard Marks) | 2026-06-30 | 6,127,212 | $251.4M | 4.73% | New position |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 2,667,827 | $109.5M | 0.06% | Reduced 25% |
| Millennium Management (Israel Englander) | 2026-06-30 | 2,098,945 | $86.1M | 0.06% | Reduced 54% |
| Point72 Asset Management (Steve Cohen) | 2026-06-30 | 1,250,639 | $51.3M | 0.08% | Added 1217% |
| Two Sigma Investments | 2026-06-30 | 312,005 | $12.8M | 0.01% | Added 78% |
| D. E. Shaw & Co. | 2026-06-30 | 236,034 | $9.7M | 0.01% | Added 16% |
| AQR Capital Management (Cliff Asness) | 2026-06-30 | 213,851 | $8.8M | 0.0% | Reduced 30% |
| Oaktree Capital Management (Howard Marks) | 2026-06-30 | 212,875,428 | $7.0M | — | Sold out |
| Gotham Asset Management (Joel Greenblatt) | 2026-06-30 | 94,850 | $3.9M | 0.01% | New position |
| Bridgewater Associates | 2026-06-30 | 68,181 | $2.8M | 0.01% | Added 84% |