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Item 1A. Risk Factors

2026-02-26 compared with 2025-03-03 · 660 added, 1088 removed, 433 unchanged (80% of the section changed)

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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.

The risks 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 Business

• We are subject to substantial litigation and ongoing investigations and information requests.

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 rely on third parties to manufacture commercial supplies of most of our products.

• 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.

• 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.

• We are subject to additional risks because we import, manufacture, and distribute controlled substances.

• We are subject to risks related to the manufacture of our products.

• 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.

• We operate in a highly competitive industry.

• We rely on some third parties to develop our pharmaceutical pipeline and conduct clinical trials.

• Clinical trials for the development of products may be unsuccessful.

• We depend on third-party payors for reimbursement for our products.

• The clinical study or commercial use of our products may cause unintended side effects.

• We face additional risks when we manufacture for others.

• We may fail to develop or acquire other new products or compounds.

• Acquisitions, partnerships, joint ventures, dispositions, and other business combinations or strategic transactions involve several inherent risks.

• The clinical study or commercial use of our products may cause unintended side effects.

• We depend on third-party payors for reimbursement for our products.

• Congress may reduce spending on Medicaid funding.

• We operate in a highly competitive industry.

• 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.

• We may be subject to adverse public opinion.

• Failure to retain key personnel or attract new personnel could have an adverse effect on us.

• We use hazardous materials in our manufacturing facilities.

• Actual costs to exit various businesses may differ materially from our estimates.

• Our product pipeline relies on collaborations with third parties.

• Clinical trials for the development of products may be unsuccessful.

Risks Related to Intellectual Property

• We may incur substantial costs as a result of intellectual property litigation or other proceedings.

• We may not be able to protect our intellectual property rights throughout the world.

• We may fail to obtain and maintain patents and protect other proprietary rights.

• Our employees may wrongfully use or disclose alleged trade secrets of their former employers.

• We may incur substantial costs as a result of intellectual property litigation or other proceedings.

Risks Related to Regulatory or Legal Matters

• The regulatory approval process is expensive, time-consuming, and uncertain.

• Regulatory agencies may impose limitations or post-approval requirements on our products.

• Guidelines published by professional societies, insurance carriers, physician groups, science foundations, and other organizations may affect the use of the Company’s products.

• We are subject to ongoing obligations and continued regulatory inspection.

• Product liability and product recalls could have a material adverse effect on us.

• We are subject to federal, state, local, and foreign healthcare laws and regulations.

• Guidelines published by professional societies, insurance carriers, physician groups, science foundations, and other organizations may affect the use of the Company’s products.

• We may fail to comply with payment and reporting obligations under governmental pricing programs.

• We are subject to healthcare fraud and abuse, transparency, and false claims laws.

• We are subject to anti-corruption laws and regulations.

• 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.

• The pharmaceutical industry faces significant government scrutiny regarding pricing and competition.

• The regulatory approval process is expensive, time-consuming, and uncertain.

Risks Related to our Financial Condition and Tax Matters

• Recently proposed tariffs on pharmaceutical products, and potential reciprocal responses by other countries, may adversely affect our revenues or profitability.

• Our balance sheet is leveraged, and any reduction in revenue may adversely affect our liquidity and profitability.

• Our business strategy may involve transactions which may dilute existing stockholders’ interests.

• Our effective tax rate may increase.

• Our deferred tax assets may not be realized.

• Tariffs on pharmaceutical products may adversely affect our revenues or profitability.

• We are subject to macroeconomic trends in the markets where we operate.

• Any reduction in annual sales may adversely affect our liquidity.

• The recent pandemic and governmental and societal responses thereto have adversely affected our business and may continue to do so.

• Our operating results may fluctuate significantly.

• Any future pandemic, and governmental and societal responses thereto, may harm our business, results of operations, and financial condition.

• Our insurance coverage may not be adequate.

• 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.

• Our deferred tax assets may not be realized.

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 Ordinary Shares

• Our ordinary shares are 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.

• Our term loan contains covenants that limit our ability to plan for or respond to changes in our business.

Risks Related to Our Common Stock

• Our common stock is subject to market price volatility.

• Securities or industry analysts may fail to publish research or may publish inaccurate or unfavorable research about our business.

• 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 may not pay dividends in the future.

• 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.

• 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.

Risks Related to Information Security and Data Privacy

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• We are required to maintain the privacy and security of personal information.

• Artificial intelligence presents risks and challenges that can impact our business including posing security risks to our confidential information, proprietary information, and personal data.

Risks Related to Our International Status and Operations

• We are subject to various risks related to the local and international nature of our business.

• We are exposed to risks related to currency exchange rates.

Risks Related to Being a Publicly-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.

• We are subject to risks related to changes in accounting standards, assumptions, and estimates.

• The obligations associated with being a public company in the U.S.

are significant.

Risks Related to our Company and Its Business

We are subject to risks related to the manufacture and distribution of our products globally and must meet stringent current Good Manufacturing Practices.

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.

Also, the manufacturing and distribution of our products globally are highly exacting and complex, due in part to strict regulatory and manufacturing requirements.

Problems may arise during manufacturing and distribution for a variety of reasons, including but not limited to equipment malfunction, failure to follow specific protocols and procedures, testing nonconformities (e.g., sterility failure), failure to follow and provide oversight in cGMP, defective raw materials, product theft or diversion within our legal chain of custody, restricted supply of raw materials or components due to geopolitical disruption or pandemic, and environmental factors.

We have either a single or dual source of supply for the raw materials, product components, and drug products used in most of our marketed products, drug product candidates under development, and their respective APIs (including buprenorphine).

Single sourcing puts us at risk of a potential interruption to supply in the event of manufacturing, quality or compliance difficulties.

In the event of any supply chain disruption or product quality issues, our suppliers or third-party manufacturers may not have adequate contingency plans in place that enable them to continue to supply or manufacture our products within contractual deadlines or at all.

If any of our suppliers or third-party manufacturers fails or refuses to supply us for any reason, it would take a significant amount of time and expense to implement and execute the necessary technology and design transfer to, and to qualify, a new supplier or manufacturer, as applicable.

Often, as a general guide, this transfer time averages 36 months and is based on several factors.

The FDA and similar international or national regulatory bodies must approve our filings which identify the manufacturers of the active and inactive pharmaceutical ingredients and certain packaging materials used in our products.

If there are delays in qualifying new suppliers or facilities or a new supplier is unable to meet the FDA’s or similar international regulatory body’s requirements for approval, there could be a shortage of the affected products for the marketplace or for use in clinical studies, or both, which could negatively impact our anticipated revenues and could potentially cause us to breach contractual obligations with customers or to violate local laws requiring us to deliver the product to those in need.

Any delay in supplying, or any failure or refusal to supply, products to, or delays in manufacturing by, our suppliers, or any catastrophe or natural or man-made disaster affecting such third-party manufacturing facilities or suppliers, could result in our inability to meet current and future state commercial demands for our products, which in turn could materially adversely affect our business, prospects, results of operations and financial condition.

The Company’s supply monitoring and contingency planning processes include proactive management of inventories throughout the supply-to-patient delivery process and initiatives to identify and qualify alternative sites and/or suppliers.

Despite these mitigating measures, if major delays, interruptions, or quality events occur at those contracted suppliers, contracted manufacturers, or packaging organizations, the delivery of products to our patients could be significantly disrupted, which could materially adversely affect the sales of our products and accompanying revenues.

Further, any interruption in supply could result in delays in meeting our contractual obligations and could damage our relationships with our licensees, including the loss of manufacturing and supply rights and/or revenues.

We rely heavily on SUBLOCADE for a significant portion of our revenues.

Historically, our business has been dependent on the sale of products containing buprenorphine.

We developed SUBUTEX Tablets, SUBOXONE Tablets, SUBOXONE Film and SUBLOCADE for the treatment of OUD.

In the last three years, SUBLOCADE has become increasingly important to our revenue growth and financial results.

SUBLOCADE accounted for 69%, 64%, and 58% of our total net revenues in 2025, 2024, and 2023, respectively.

Our oral buprenorphine products, including SUBOXONE Film, SUBOXONE Tablets, and SUBUTEX Tablets, are subject to substantial competition.

Revenues from film and tablet products are declining.

Further, in the Resolution Agreement we agreed not to employ a sales force to promote or sell SUBOXONE Film in the U.S., and in our settlement agreement with the States for Opioid MDL we agreed to restrictions that effectively prohibit marketing of SUBOXONE FILM through 2032.

See generally, " We are currently, in the past have been, and in the future may be, subject to substantial litigation that could cause us to incur significant legal expenses, divert management’s attention, and result in harm to our business," above.

Further, we do not sell SUBOXONE Tablets or SUBUTEX Tablets in the U.S.

As a result, sales of SUBLOCADE are very important to our revenue growth and financial results.

Our operating plan assumes that SUBLOCADE, SUBOXONE Film, and SUBUTEX Tablets will remain the treatment of choice for OUD patients who can benefit from MAT in the countries where we sell these products.

There is no guarantee that we can maintain sales at or near historical levels, or that sales will continue to grow.

In this regard, our ability to maintain or increase sales are subject to a number of risks and uncertainties including (i) competition from the introduction of branded competition or generic versions of our products;

(ii) pricing pressure from, changes in policies by, or restrictions on reimbursement imposed by, third-party payors, including governments, and our ability to maintain adequate coverage and reimbursement for our products;

(iii) increased rebates required to maintain access to our products;

(iv) challenges to our intellectual property around SUBLOCADE;

and (v) continued acceptance of SUBLOCADE by physicians and patients.

In addition, Congress continues to consider various policy proposals that may result in pressure on the prices of prescription drugs in government healthcare programs in efforts to decrease government spending.

See " Congressional action to reduce spending may result in cuts to Medicaid which in turn might impair access to our products in the U.S., thereby adversely affecting our revenues and results of operations," above.

Further, as organized health systems consolidate, in part due to private equity activity, we may be required to increase rebates, which would reduce the profitability of our products.

Any significant negative developments relating to these risks could have a material adverse effect on our revenues from these products and, in turn, on our business, financial condition, cash flows and results of operations and the market price of our common stock.

Further, the biopharmaceutical and biotechnology industries are characterized by rapidly advancing technologies.

Our future success will depend in part on our ability to maintain a competitive position.

If we fail to stay at the forefront of technological change to create and develop product candidates, we may be unable to compete effectively.

Our competitors or technological change may limit the commercial value of our products by advances in existing technological approaches or the development of new or different approaches, potentially eliminating the advantages of our proprietary products and product candidates.

Our revenues may grow at a slower than expected rate or decrease due to many factors.

Sales may not grow, and may decline.

Risks to revenue growth include:

• potential changes to government funding at the federal, state, and local levels;

• the perception of physicians and other members of the healthcare community as to our products’ safety and efficacy relative to that of competing products and the willingness or ability of physicians and other members of the healthcare community to prescribe, dispense and/or administer, and patients to use, our products;

• unfavorable publicity concerning us, our products, similar classes of drugs or the industry generally;

• the cost-effectiveness of our products, the impact of price changes in the market, and the reimbursement policies of government and third-party payors;

• patient and physician satisfaction with our products;

• significant changes in the competitive landscape for our products, including any approval of generic versions of our products or other branded products that may compete with our products;

• adverse event information relating to our products or to similar classes of drugs;

• changes to the labels of our products, or of products within the same drug classes, to add significant warnings or restrictions on use;

• regulatory developments and actions related to the manufacture, commercialization or continued use of our products, including FDA actions such as required changes to our REMS or a warning letter, or conduct of an audit by the FDA or another regulatory authority in which a manufacturing or quality deficiency is identified;

and global political changes and/or instability, including trade relations, and any related changes in applicable laws and regulations, that may impact resources and markets for our products;

• the potential negative impact of current and future healthcare laws and legislation and regulation controlling the conditions of treatment and the distribution of the product including, with respect to OUD treatments, new governmental or regulatory guidelines or policies limiting the prescription of opioids to patients.

We rely on third parties to manufacture, package, test, and distribute our products and their facilities and processes must meet stringent regulatory requirements.

The Company relies almost exclusively on third parties, including contract manufacturing organizations, to manufacture, package, test, and distribute our products.

The manufacturing of our products, which include terminally sterilized and aseptically filled injectables, film products, and oral solid dose tablet products, is subject to stringent global regulatory, quality, and safety standards, including current Good Manufacturing Practice (“cGMP”).

Some of our products, including SUBLOCADE long-acting injectable and SUBOXONE Film, are significantly more complicated to manufacture than tablet products.

We have limited control over the performance of our third-party manufacturers and are currently dependent on our third-party contract manufacturing partners whom we manage via supply and quality agreements.

We or our third-party manufacturers may encounter difficulties in production, such as issues with production costs and yields, process controls, quality control, and quality assurance, including testing of stability, impurities and impurity levels, sterility, and other product specifications by validated test methods, compliance with strictly enforced global and regional regulations, and disruptions or delays caused by man-made or natural disasters, pandemics or epidemics, or other business interruptions.

Similarly, the Company relies on a third-party logistics vendor and a network of specialty pharmacists and specialty distributors to fulfill orders and distribute our products in the U.S.

and logistics and distribution partners to distribute our products worldwide.

This process is complicated because our products contain controlled substances that require special handling, such as import and export permits, adherence to a risk evaluation and mitigation strategy (“REMS”) protocol, and import restrictions on controlled substances.

See below, “ We are subject to additional risks because we import, manufacture, and distribute controlled substances.”

If we or any of our third-party manufacturers cannot successfully manufacture material that conforms to our specifications and the applicable regulatory authorities’ strict regulatory requirements or pass regulatory inspection, we or our third-party manufacturers will not be able to ensure an adequate supply of products and/or secure or maintain regulatory approval for the manufacturing facilities.

In addition, we have no direct control over the ability of third-party manufacturers to maintain adequate quality control, quality assurance

and qualified personnel.

If the FDA does not approve these facilities for the manufacture of our products or if they withdraw any such approval in the future, or if the supply of our primary active ingredients or manufacture of our products is somehow interrupted, we may need to find alternative manufacturing facilities, which may significantly impact our ability to develop, obtain regulatory approval for or market our products.

To the extent our manufacturing facility or that of any third-party manufacturers that we engage with respect to our products are different from those currently being used for commercial supply in the U.S., studies will have to be completed, and the FDA will need to approve such facilities prior to our sale of any product manufactured using these facilities.

Any delay or interruption in our ability to meet commercial demand for our products will result in the loss of potential revenues and could adversely affect our ability to gain market acceptance for these products.

In addition, any delay or interruption in the supply of clinical trial supplies could delay the completion of clinical trials, increase the costs associated with maintaining clinical trials, and, depending upon the period of delay, require us to commence new clinical trials at additional expense or terminate clinical trials completely, which in turn could have a material adverse effect on our business financial condition, and results of operations.

Our ability to generate revenues from our products is subject to attaining significant market acceptance among key healthcare stakeholders and our ability to successfully develop and execute commercialization strategies for each of our products.

Failure to do so would adversely impact our financial condition and prospects.

A substantial majority of our resources are focused on the commercialization of our current products.

Our current and future products may not achieve market acceptance.

If any of our commercial strategies are unsuccessful or we fail to successfully modify our strategies over time due to changing market conditions, our ability to increase category share for our products, grow revenues and sustain profitability will be harmed.

For example, SUBLOCADE was approved in 2017 as the first once-monthly subcutaneous extended-release injectable suspension of buprenorphine.

We initiated commercial sales of SUBLOCADE in 2018.

It took until 2020 to reach $100 million in annual net revenues for SUBLOCADE.

In the U.S., a competitor introduced its own subcutaneous extended-release injectable suspension of buprenorphine in 2023.

We believe the degree of market acceptance and our ability to generate revenues from our products depends on several factors, including:

• the timing of market introduction of our products as well as competitive products;

• our ability to manufacture in sufficient quantities in compliance with requirements of regulatory agencies and at acceptable quality and pricing levels in order to meet commercial demand and where applicable demand for samples;

• our ability to secure formulary approvals for products at a substantial number of targeted hospitals and Organized Health Systems (“OHSs”);

• our ability to implement and maintain agreements with wholesalers and distributors on commercially reasonable terms, and their performance, over which we have limited control;

• our ability to receive adequate levels of coverage and reimbursement for products from commercial health plans and government health programs;

• our ability to train, deploy and support qualified customer-facing field teams which include a sales force, a managed care team, account teams that target OHSs, as well as a channel team;

• market demand for our products through our marketing and sales activities and other arrangements established for their promotion;

• the efficacy and safety of our products;

• potential or perceived advantages or disadvantages of our products over alternative treatments, including the cost of treatment and relative convenience and ease of administration;

• the prevalence of the disease or condition for which the product is approved and the projected growth of the markets in which our products compete;

• the effect of current and future healthcare laws and legislation and regulation controlling the conditions of treatment and the distribution of the products for OUD;

• our ability to increase overall public awareness of the opioid epidemic and approved treatments, as well as increasing access to BMAT treatments for patients via regulatory and legislative actions to increase access;

• the extent to which physicians diagnose and treat the conditions that our products are approved to treat, physicians’ willingness to prescribe the product, and our ability to educate physicians with respect to new products;

• the prevalence and severity of any side effects;

• the price of our products, both in absolute terms and relative to alternative treatments, including the impact of past or expected future product price increases;

• product labeling or product insert requirements of the FDA or other regulatory authorities;

• the nature of any post-approval risk management plans mandated by regulatory authorities;

see “ We are subject to additional risks because we import, manufacture, and distribute controlled substances, ” above,

• the convenience of prescribing, administrating and initiating patients on the product, and

• our ability to communicate the benefits of our products, including through direct-to-consumer advertising.

Any factors preventing or limiting the market acceptance or commercialization of our products could have a material adverse effect on their sales and hence our business, results of operations and financial condition.

We are currently, in the past have been, and in the future may be, subject to substantial litigation that could cause us to incur significant legal expenses, divert management’s attention, and result in harm to our business.

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.

We are currently subject to several significant unresolved matters, including:

• The Company has been named as a defendant in numerous lawsuits alleging that SUBOXONE Film was defectively designed and caused dental injury, and that the Company failed to properly warn of the risks of such injuries.

The plaintiffs generally seek compensatory damages, as well as punitive damages and attorneys’ fees and costs.

These claims follow a June 2022 required revision to the Prescribing Information and Patient Medication Guide about dental problems reported in connection with buprenorphine medicines dissolved in the mouth to treat opioid use disorder.

This revision was required by the FDA of all manufacturers of these products.

Applications to file class actions based on similar allegations as in the Dental MDL, but also relating to SUBOXONE Tablets, were filed in Quebec and British Columbia against various subsidiaries of the Company, among other defendants, in April 2024, following a required label change by Health Canada.

Product liability cases such as these typically involve issues relating to medical causation, label warnings and reliance on those warnings, scientific evidence and findings, actual/provable injury, and other matters.

• On September 21, 2022, certain stockholders issued representative and multiparty claims against Indivior PLC in the High Court of Justice for the Business and Property Courts of England and

Wales, King’s Bench Division.

The claims made in both the representative and multiparty actions generally allege that Indivior PLC violated the U.K.

Financial Services and Markets Act 2000 (“FSMA 2000”) by making false or misleading statements or material omissions in public disclosures, including the 2014 Demerger Prospectus, regarding an alleged product-hopping scheme regarding the switch from SUBOXONE Tablets to SUBOXONE Film.

The claims related to the multiparty are now proceeding in the High Court, although they remained pending while Indivior proceeded to successfully to strike out the representative action.

For a more detailed discussion involving the Company’s legal proceedings and associated accounting estimates, see Item 8.

Financial Statements—Audited Consolidated Financial Statements - Note 16.

Commitments and Contingencies , especially at the captions "Dental Allegations" and "U.K.

Stockholder Claims," which provide information regarding additional matters that we believe may be significant to the Company as of the date of the filing of this annual report.

In the past we were, and in the future may be, subject to litigation that could cause us to incur significant legal expenses, divert management’s attention, and result in harm to our business.

• In 2019, the U.S.

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and Indivior PLC with health care fraud, mail fraud, wire fraud, and conspiracy to commit the same.

It generally alleged that the Company had falsely represented that SUBOXONE film was safer and less susceptible to misuse, abuse, diverse, and inadvertent pediatric exposure than SUBOXONE tablets, purportedly to delay approval of generic versions of SUBOXONE tablets and retain market share.

It generally alleged that the Company had falsely represented that SUBOXONE film was safer and less susceptible to misuse, abuse, diversion, and inadvertent pediatric exposure than SUBOXONE tablets, purportedly to delay approval of generic versions of SUBOXONE tablets and retain category share.

Pursuant to a Resolution Agreement made on July 24, 2020 as part of a global resolution with the U.S.

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The DOJ dismissed all charges in the indictment, and the Company agreed to a total of $600 million in fines and agreed to substantial reporting and compliance obligations related to its U.S.

operations, among other things.

The Resolution Agreement is filed as Exhibit 10.2 to this annual report.

• In January 2021, the Company announced it had reached an agreement with Reckitt Benckiser Group plc (“RB”) to resolve claims that RB issued in the Commercial Court in London in November 2020, seeking indemnity under the Demerger Agreement entered into on November 17, 2014 between RB and Indivior to effect the Demerger and to govern the relationship between RB and the Company following the Demerger.

Pursuant to the settlement, RB agreed to withdraw its $1.4 billion claim and to release the Company from any claim for indemnity under the Demerger Agreement relating to the DOJ and FTC settlements that RB entered into in July 2019, as well as other claims for indemnity arising from those matters.

The Company agreed to pay RB a total of $50 million and released RB from any claims to seek damages relating to the Company’s settlement with the DOJ and the FTC.

operations with the DOJ and HHS-OIG, among other things.

The Company completed its obligations under the Resolution Agreement in November 2025 after it paid the final amounts owed.

• In July 2022, the Company settled antitrust, patent infringement, and wrongful injunction claims with the manufacturer of a generic buprenorphine/naloxone film drug product for approximately $72 million and approximately $15 million for similar claims made by a second manufacturer of such a generic film drug product in October 2023.

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District Court for the Eastern District of Pennsylvania (the “Antitrust MDL”) for $385 million, $30 million, and $103 million, respectively.

During 2024, Indivior settled state-court cases in Virginia, Kentucky, and Pennsylvania with all of the remaining insurance companies who had asserted claims similar to those asserted in the Antitrust MDL but opted out of the Antitrust MDL end payor class for a combined total of $125 million, payable through December 2025.

We are also subject to several significant unresolved matters.

• The Company has been named as a defendant in more than 400 civil lawsuits alleging that manufacturers, distributors, and retailers of opioids engaged in a longstanding practice to market

opioids as safe and effective for the treatment of long-term chronic pain to increase the market for opioids and their own market share, or alleging individual personal injury claims (the "Opioid MDL").

Most of these cases have been consolidated and are pending in a federal multi-district litigation in the U.S.

District Court for the Northern District of Ohio.

Nearly two-thirds of the cases in the Opioid MDL were filed by cities and counties, while nearly one-third of the cases were filed by private plaintiffs, most of whom assert claims relating to neonatal abstinence syndrome ("NAS").

Pursuant to mediation, the Company reached agreement on the amount of a potential settlement.

However, the parties still must negotiate material terms and conditions of the final settlement agreement, including the structure and scope of the release.

The proposed settlement would resolve claims by cities and counties, but would not resolve private plaintiff cases against the Company and would not resolve claims brought outside of the MDL.

• the Company has been named as a defendant in numerous lawsuits alleging that SUBOXONE Film was defectively designed and caused dental injury, and that the Company failed to properly warn of the risks of such injuries.

The plaintiffs generally seek compensatory damages, as well as punitive damages and attorneys’ fees and costs.

These lawsuits and claims follow a June 2022 required revision to the Prescribing Information and Patient Medication Guide about dental problems reported in connection with buprenorphine medicines dissolved in the mouth to treat opioid use disorder.

This revision was required by the FDA of all manufacturers of these products.

• On September 21, 2022, certain shareholders issued representative and multiparty claims against Indivior PLC in the High Court of Justice for the Business and Property Courts of England and Wales, King’s Bench Division (the "High Court").

The claims made in both the representative and multiparty actions generally allege that Indivior PLC violated the U.K.

On December 5, 2023, the High Court handed down a judgment allowing the Company's application to strike out the representative action.

This decision was affirmed by the court of appeals on January 23, 2025.

On February 20, 2025, the claimants notified the Company that they intend to appeal the judgment in the representative action to the U.K.

Supreme Court.

The multi-party proceeding remains pending.

During 2024, Indivior settled state-court cases for a combined total of $125 million in Virginia, Kentucky, and Pennsylvania with all of the remaining insurance companies who had asserted claims similar to those asserted in the Antitrust MDL but opted out of the Antitrust MDL end payor class.

• The Company was named as a defendant in numerous civil lawsuits alleging that manufacturers, distributors, and retailers of opioids engaged in a longstanding practice to market opioids as safe and effective for the treatment of long-term chronic pain to increase the market for opioids and their own market share or alleging individual personal injury claims.

Most of these cases were consolidated and stayed in a federal multi-district litigation in the U.S.

District Court for the Northern District of Ohio (the "Opioid MDL").

Nearly two-thirds of the cases in the Opioid MDL were filed by cities and counties ("Subdivisions"), and Tribal Nations, while nearly one-third of the cases were filed by private individual plaintiffs, most of whom assert claims relating to neonatal abstinence syndrome ("NAS").

A small number of cases were filed by additional types of plaintiffs such as

schools, hospitals, third-party payors, and charitable organizations.

In 2024, following mediation, the Company, the Plaintiffs' Executive Committee (PEC) that represented the Subdivisions, and an executive committee of state attorneys general reached a framework for a potential settlement which would allow Subdivisions, including those cities and counties that filed suit against Indivior, to participate.

The States (except Maryland) and the Company finalized an agreement reflecting the terms of that potential settlement on April 4, 2025, and the settlement became final in January 2026.

The Compa ny separately executed a master settlement agreement with the Tribal Nations, and all Tribal Nations that sued the Company.

In January 2026, the Company reached an agreement in principle with the State of Maryland related to the same allegations.

The accrued cost of the settlements as of December 31, 2025 was $80 million.

The proposed settlements would resolve claims by Subdivisions, public hospitals, public schools, and Tribal Nations, including those brought in courts outside of the Opioid MDL, but would not resolve third-party payor, charitable organization, or private individual plaintiff cases against the Company either within or outside of the Opioid MDL.

The amount of time that is required to resolve legal or regulatory proceedings is unpredictable and any litigation or claims against us, even those without merit, may cause us to incur substantial costs, divert management’s attention from the day-to-day operation of our business, and materially harm our stock price and reputation.

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Various factors or developments can lead the Company to change current estimates of liabilities and, to the extent applicable, related insurance receivables, or make such estimates for matters previously not susceptible of reasonable estimates, such as a significant judicial ruling or judgment, a significant settlement, significant regulatory developments or changes in applicable law.

A future adverse ruling, settlement or unfavorable development could result in future charges that could have a material adverse effect on the Company’s results of operations or cash flows in any

particular period.

A future adverse ruling, settlement or unfavorable development could result in future charges that could have a material adverse effect on the Company’s results of operations or cash flows in any particular period.

In addition, negative publicity related to these proceedings may negatively impact the Company’s reputation.

For a more detailed discussion involving the Company’s legal proceedings and associated accounting estimates, see Item 8 .

Financial Statements—Audited Consolidated Financial Statements - Note 16.

Commitments and Contingencies of this Report , especially at the captions “Civil Opioid Litigation” and "Dental Allegations" which provide information regarding additional matters that we believe may be significant to the Company as of the date of the filing of this annual report.

We rely on third parties to manufacture, package, test, and distribute our products and their facilities and processes must meet stringent regulatory requirements.

The Company relies almost exclusively on third parties, including contract manufacturing organizations, to manufacture, package, test, and distribute our products.

The manufacturing of our products, which include oral solid dose tablet products, film products, a nasal spray product, and terminally sterilized and aseptically filled injectables, is subject to stringent global regulatory, quality, and safety standards, including current Good Manufacturing Practice (“cGMP”).

Some of our products, including SUBOXONE Film, SUBLOCADE long-acting injectable, and OPVEE nasal spray, are significantly more complicated to manufacture than tablet products.

Similarly, the Company relies on a third-party logistics vendor and a network of specialty pharmacists and specialty distributors to fulfill orders and distribute our products in the U.S.

and logistics and distribution partners to distribute our products worldwide.

This process is complicated because most of our products contain controlled substances that require special handling, such as import and export permits, adherence to a risk evaluation and mitigation strategy (“REMS”) protocol, and import restrictions on controlled substances.

See also Item 1A.

Risk Factors—“ The pharmaceutical sector is facing increased government scrutiny from competition and pricing authorities around the world, and any failure to comply, may expose us to significant damages and commercial restrictions that can materially and adversely affect our business.

Our revenues may grow at a slower than expected rate or decrease due to many factors.

We cannot be assured that we will be able to maintain or increase sales of our products.

Factors that may cause revenues from our products to grow at a slower than expected rate, decrease or cease altogether, include, among others:

• potential changes to government funding at the federal, state, and local levels;

• unfavorable publicity concerning us, our products, similar classes of drugs or the industry generally;

• the cost-effectiveness of our products, the impact of price changes in the market, and the reimbursement policies of government and third-party payors;

• the cost and availability of raw materials necessary for the manufacture of our products;

• the successful manufacture of our products on a timely and cost-effective basis;

• the size of the markets for our products, and patient and physician satisfaction with our products;

• significant changes in the competitive landscape for our products, including any approval of generic versions of our products or other branded products that may compete with our products;

• adverse event information relating to our products or to similar classes of drugs;

• changes to the labels of our products, or of products within the same drug classes, to add significant warnings or restrictions on use;

• regulatory developments and actions related to the manufacture, commercialization or continued use of our products, including FDA actions such as the issuance of a REMS or warning letter, or conduct of an audit by the FDA or another regulatory authority in which a manufacturing or quality deficiency is identified;

• the extent and effectiveness of the sales, marketing and distribution support for our products, including our licensees’ decisions as to the timing and volume of product orders and shipments, the timing of product launches, and product pricing and discounting;

• exchange rate valuations and fluctuations;

and global political changes and/or instability, and any related changes in applicable laws and regulations, that may impact resources and markets for our products;

• the potential negative impact of current and future healthcare laws and legislation and regulation controlling the conditions of treatment and the distribution of the product including, with respect to OUD or overdose reversal treatments, new governmental or regulatory guidelines or policies limiting the prescription of opioids to patients.

We operate in a highly competitive industry, which includes companies with greater resources, including larger R&D and sales organizations, and more experience working with large and diverse product portfolios, than us.

The approval and launch of generic or branded products that compete with SUBLOCADE, SUBOXONE Film, SUBOXONE Tablet, and SUBUTEX Tablet could have a material adverse effect on our business, prospects, results of operations and financial condition.

Revenues from our products depend on the availability, scope, and level of reimbursement from government and private payors in the U.S.

Any reduction of reimbursement, increase in patient cost-sharing obligations, delays in coverage determinations, or restrictions on coverage could reduce the utilization of our products and materially adversely affect our business, financial condition, cash flows and results of operations.

Third-party payors are under increasing pressure to control healthcare costs and are adopting measures that may limit or reduce reimbursement for pharmaceutical products, including our products.

These measures include prior authorization requirements, step-therapy protocols, formulary exclusions or tiering, higher patient co-payments or deductibles, coverage limitations, mandatory discounts or rebates, and increased use of managed care arrangements.

Payors may also encourage or require the use of lower-cost generic products or alternative therapies, which may reduce demand for our products.

Government authorities and private payors increasingly evaluate pharmaceutical products based on cost-effectiveness, in addition to safety and efficacy, when making coverage and reimbursement decisions.

As a result, we may be required to generate additional pharmacoeconomic, real-world, or clinical data to support favorable reimbursement determinations, which could be costly and may not achieve the desired outcomes.

If our competitors can demonstrate lower treatment costs or otherwise position their products as more cost effective, they may obtain broader or more favorable access than our products.

In addition, pricing, reimbursement, and coverage decisions are subject to significant regulatory and legislative scrutiny.

federal and state governments continue to consider and implement initiatives to reduce healthcare spending, including drug pricing transparency laws, price controls, supplemental rebate requirements, and restrictions on coverage under Medicare and Medicaid programs.

Similar cost-containment strategies are implemented by government-sponsored healthcare systems in other countries, including mandatory price reduction, reference pricing, and access restriction, any of which could reduce revenues or limit our ability to achieve acceptable pricing.

third-party payors, including pharmacy benefit managers, may further exert negotiating leverage by requiring increased rebates or other concessions as a condition of formulary inclusion or continued coverage.

Failure to obtain or maintain favorable formulary placement could increase patient cost-sharing, delay treatment initiation, reduce adherence, or result in patients foregoing treatment altogether, which could negatively affect commercialization efforts and revenues.

If we are unable to obtain and maintain adequate reimbursement, or if reimbursement is provided only on unfavorable terms, demand for our products could decline our business, prospects, and results of operations could be materially adversely affected.

See also, “ The pharmaceutical sector is facing increased government scrutiny from competition and pricing authorities around the world, and any failure to comply, may expose us to significant damages and commercial restrictions that can materially and adversely affect our business,” below.

Congressional action to reduce spending, such as the 2025 budget reconciliation act (OBBBA), could lead to Medicaid cuts.

These cuts may reduce patient eligibility, limit coverage of higher-cost treatments for OUD, and impose Medicaid work or eligibility requirements.

Such changes could impair patient access to our products, thereby adversely affecting our revenues and results of operations.

Any cuts in Medicaid may impair access to our products in the U.S., thereby adversely affecting our revenues and results of operations.

We operate in a highly competitive industry, which includes companies with greater resources than us.

The approval and launch of generic or branded products that compete with SUBLOCADE, and an additional generic competitor for SUBOXONE Film, could have a material adverse effect on our business, prospects, results of operations and financial condition.

The manufacture and sale of pharmaceuticals are highly competitive.

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Companies with more extensive resources and larger research and development expenditures have a greater ability to fund clinical trials and other development work necessary for regulatory applications.

There is also a risk that our competitors may launch competing products before we are able to complete all of the regulatory milestones required to launch our own product.

Competitors may also have a greater ability to offer higher rebates, discounts, chargebacks or other incentives to gain commercial advantage, and may be more successful than us in acquiring or licensing new products for development and commercialization.

Smaller or earlier-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies.

If any product that competes with one of our products or product candidates is approved, our sales of that product could decrease, the effect of which would be heightened by our product and geographic concentration, which could have an adverse impact on our business, prospects, results of operations and financial condition.

For example, SUBLOCADE now faces competition from BRIXADI in the U.S., and OPVEE competes with Narcan ® and other generic products and other types of overdose reversal drugs , discussed below.

Our products also compete with various alternatives including oral buprenorphine, methadone, and other drugs indicated for OUD, and intravenous overdose reversal agents.

In addition, many pharmaceutical companies are able to deploy more personnel to market and sell their products than us.

If any product that competes with one of our products is approved, our sales of that product could decrease, the effect of which would be heightened by our product and geographic concentration, which could have an adverse impact on our business, prospects, results of operations and financial condition.

For example, SUBLOCADE faces competition from BRIXADI in the U.S.

Our products also compete with various alternatives including oral buprenorphine, methadone, and other drugs indicated for OUD and, in the future, may experience competition from other therapies or drugs.

Our SUBOXONE Film product has faced four generic competitors in the U.S.

for some time.

We have seen our category share of film decline from greater than 50% in 2018 to an average share of 14.2% in 2025 and expect further declines as other competing products become available or if existing participants choose to disrupt the market in line with industry analogs.

Additionally, we no longer promote SUBOXONE Film in the U.S.

For a discussion of the competition that we face with respect to our current marketed products, technology platforms and product indications, please see the section entitled “ Competition ” in “ Item 1.

Business ” in this annual report.

If we are unable to compete successfully in this highly competitive industry, our business, financial condition, cash flows and results of operations could be materially adversely affected.

In addition, some pharmaceutical companies may be able to deploy more personnel to market and sell their products than us.

Each of our sales representatives is responsible for a territory of significant size.

The continued growth of our current products and the launch of any future products may require the expansion of our sales force and sales support organization internationally and we may need to commit significant additional funds, management and other resources to the growth of our field organization.

The continued growth of our current products may require the expansion of our sales force and sales support organization and we may need to commit significant additional funds, management and other resources to the growth of our field organization.

We may not be able to achieve any such necessary growth in a timely or cost-effective manner or at all or realize a positive return on our investment.

Likewise, if our R&D organization is not appropriately sized to effectively develop our current pipeline and future pipeline projects, the commercial net present value of our current pipeline and any future pipeline projects may be diminished.

This in turn could materially and adversely affect our business prospects, results of operations, and financial position.

Critically, investment in a novel asset pipeline is required to ensure the sustainability of Indivior through the launch of new medicines as our existing products face increasing competition through generics and alternatives.

The pharmaceutical and biotechnology industries are also characterized by continuous product development and technological change.

Our products could, therefore, be rendered obsolete or uneconomic through the development of new products with unique advantages (including, e.g., new chemical entities that may be safer, more effective or more convenient than our products) or by technological advances in manufacturing or production by our competitors.

In particular, several of our branded products face competition from generic products in key markets as well as competition from alternative products or treatments.

Our products could, therefore, be rendered obsolete or

uneconomic through the development of new products with unique advantages (including, e.g., new medicines that may be safer, more effective, or more convenient than our products) or by technological advances in manufacturing or production by our competitors.

Among other things, competition could continue to require us to increase further the level of rebates and other offsets to gross revenues, particularly in our U.S.

operations, and could impact potential volume growth of any particular product, which could reduce our net revenues and therefore our results of operations in future periods.

Branded Products

The introduction of branded products that compete with our products may lead to a loss of sales of our products and/or a decrease in the price at which our products can be sold.

For example, SUBLOCADE is distributed primarily in the U.S., Australia, Canada, Finland, Israel, and Sweden.

However, Camurus, in partnership with Braeburn Pharmaceuticals, Inc., in 2023 obtained FDA approval of its LAI buprenorphine product which now competes with SUBLOCADE in the U.S.

Additionally, we expect that Camurus may eventually seek approval in Canada.

Camurus’ product is already well established in Sweden, Finland, Norway, and Australia, and is available in additional countries.

We are seeing more dual prescribing HCPs, and we believe this trend will continue as HCPs obtain familiarity with both medications.

Any of the foregoing competitive developments could have a material adverse effect on our business, prospects, results of operations and financial condition.

Among other things, developments of this nature have in the past, and could in the future, require the Company to increase further the level of rebates and discounts and other offsets to gross revenues, particularly in its U.S.

operations, as well as impact potential volume growth of any affected products, which, in turn, could reduce net revenues and, therefore, its results in future periods.

In addition, we could face competition even where we have patent protection.

As noted above, Camurus developed an alternative to our product that ostensibly uses technology which does not infringe our patents.

Alternatively, a competitor might seek to compete by asserting that our patent is either invalid, not infringed by their product, or not enforceable.

Patients and HCPs may also use alternatives to our products, such as methadone.

Similarly, OPVEE (nalmefene) nasal spray competes against branded and generic naloxone nasal sprays, including Narcan ® (naloxone HCI) Nasal Spray 4 mg (which is available without a prescription), along with 4 mg naloxone generic equivalents, and Kloxxado ® (naloxone HCI) Nasal Spray 8 mg, as well as naloxone or nalmefene administered by syringe.

Generic Products

The introduction of generic products typically leads to a loss of sales of the branded product and/or a decrease in the price at which branded products can be sold, particularly when there is more than one generic product available in the market.

In addition, legislation enacted in the U.S.

allows for the dispensing of generic products and, in some instances, the dispensing of generic products rather than branded products may be required (in the absence of specific instructions from the prescribing physician).

If we fail to obtain or maintain adequate patent protection, we may not be able to prevent third parties from launching generic or biosimilar versions of SUBLOCADE.

Our SUBOXONE Film product has faced four generic competitors in the U.S.

for some time, and we expect a fifth competitor in early 2025.

We have seen our market share of film decline from greater than 50% in 2018 to an average share of 16% in 2024 and expect further declines as other competing products become available or if existing participants choose to disrupt the market in line with industry analogs.

Additionally, we no longer promote SUBOXONE Film in the U.S.

and no longer sell or market our SUBUTEX Tablets and SUBOXONE Tablets in the U.S.

Where we sell out tablet products globally, we generally face generic competition.

For a detailed discussion of the competition that we face with respect to our current marketed products, technology platforms and product indications, please see the section entitled

“ Competition ” in “ Item 1.

Business ” in this annual report.

If we are unable to compete successfully in this highly competitive industry, our business, financial condition, cash flows and results of operations could be materially adversely affected.

Failure to retain key personnel or attract new personnel could have a material adverse effect on us.

We rely upon several key executives and employees who have an in-depth and long-term understanding of the industry and the disease space and our technologies, products, programs, collaborative relationships and strategic goals.

Key personnel include experienced employees with specific expertise and the ability to compliantly interact with healthcare providers, key opinion leaders, and key decision-makers across the healthcare industry.

We compete with other pharmaceutical and life sciences companies to recruit, hire, train and retain sales and marketing personnel as well as research and development personnel.

Competition for such personnel in the pharmaceutical and biotechnology industries is intense, and there can be no assurance that we will be able to recruit or retain such personnel.

If our sales force and sales organization are not appropriately sized to promote any current or potential future products adequately, the commercial potential of our current products and any future products may be diminished.

We do not carry “key person” insurance.

The loss of the services of any of our key executives or employees could delay or prevent the successful completion of some of our vital activities.

Any employee may terminate his or her employment at any time without notice or with only short notice and without cause or good reason.

The resulting loss of institutional knowledge may have a material adverse effect on our operations and future growth.

As a result of the above factors, any failure to retain key personnel or attract new personnel could have a material adverse effect on our business, prospects, results of operations and financial condition.

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.

In the U.S., we are subject, directly or indirectly through our customers and other third parties, to various federal, state and local fraud and abuse and transparency laws.

Our sales, marketing, patient support and medical activities may be subject to scrutiny under these laws.

federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving anything of value to induce (or in return for) the referral of business, including the purchase, recommendation or prescription of a particular drug reimbursable under Medicare, Medicaid or other federally financed healthcare programs.

The statute has been interpreted to apply to arrangements between pharmaceutical companies on one hand and patients, prescribers, purchasers and formulary managers on the other.

Although there are several statutory exceptions and regulatory safe harbors protecting certain common manufacturer business arrangements and activities from prosecution and administrative sanction, the exceptions and safe harbors are drawn narrowly and are subject to regulatory revision or changes in interpretation by the DOJ and HHS-OIG.

Practices or arrangements that involve remuneration may be subject to scrutiny if they do not qualify for an exception or safe harbor.

Violations of the federal Anti-Kickback Statute may be established without providing specific intent to violate the statute.

Several courts have interpreted the statute’s intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare covered business, the statute has been violated.

Violations of the Anti-Kickback Statute may be punishable by civil, criminal, and administrative fines and penalties, damages, imprisonment, and/or exclusion from participation in federal healthcare programs.

federal civil False Claims Act prohibits, among other things, any person from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of federal funds, or knowingly making, or causing to be made, a false statement to get a false claim paid.

A claim resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim.

The False Claims Act also permits a private individual acting as a “whistleblower” to bring actions on behalf of themselves and the federal government alleging violations of the statute and to share in any monetary recovery.

Violations of the False Claims Act may result in significant financial penalties (including mandatory penalties on a per claim or statement basis), treble damages and exclusion from participation in federal healthcare programs.

Pharmaceutical companies are subject to other federal false claims and statements laws, some of which extend to non-government health benefit programs.

For example, the healthcare fraud provisions under the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations, or HIPAA, impose criminal liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors, or falsifying or covering up a material fact or making any materially false or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

Violations of HIPAA fraud provisions may result in criminal, civil and administrative penalties, fines and damages, including exclusion from participation in federal healthcare programs.

The majority of individual states also have statutes or regulations similar to the federal Anti-Kickback Statute and the False Claims Act, which apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor.

Other states restrict whether and when pharmaceutical companies may provide meals or other items of value to healthcare professionals or engage in other marketing-related activities, and certain states and cities require the identification or licensing of sales representatives.

The Physician Payment Sunshine Act requires tracking of payments and transfers of value to physicians and teaching hospitals and ownership interests held by physicians and their families, and reporting to the federal government and public disclosure of these data.

Since 2022, reporting is also required regarding payments and transfers of value provided to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwives.

A number of states also require pharmaceutical companies to report expenses relating to the marketing and promotion of pharmaceutical products and to report gifts and payments to healthcare providers in the states.

Government agencies and private entities may inquire about our marketing practices or pursue other enforcement activities based on the disclosures in those public reports.

We may also be subject to state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers, marketing expenditures or drug pricing, and state and local laws that require the registration of pharmaceutical sales representatives.

We are further subject in a similar manner to federal and state data privacy and security laws, such as HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, the Confidentiality of Substance Use Disorder Patient Records (42 C.F.R.

Part 2), state consumer privacy laws, and state breach reporting requirements.

Collectively, these laws may affect, among other things, our current and proposed research, sales, marketing and educational programs, as well as other possible relationships with customers, pharmacies, physicians, payers, and patients.

An expanding number of U.S.

states have enacted comprehensive privacy laws imposing differing and increasingly stringent requirements, and regulators and state attorneys general have become more active in enforcing these laws, further increasing our compliance and enforcement risk.

We are subject to similar data privacy and security laws in Europe and other countries, including the EU General Data Protection Regulation (2016/679), or GDPR, under which fines of up to €20.0 million or up to 4% of the annual global revenue of the infringer, whichever is greater, could be imposed for significant non-compliance.

We are also subject to qui tam , or

whistleblower lawsuits, under the False Claims Act.

Compliance with these laws, including the development of a comprehensive compliance program, is difficult, costly and time-consuming.

Outside the US, we are also subject to extensive and evolving laws and regulations, including those relating to anti-bribery and corruption.

and product commercialization.

Some of those requirements may be more rigorous than in the US, may differ significantly from country to country and may be enforced differently from comparable U.S.

If we are found to be in violation of these laws or regulations, we could be subject to fines, civil or criminal sanctions, exclusion from government healthcare programs, withdrawal of marketing authorizations, product seizures or injunctions, and other penalties that could materially harm our business and financial standing.

Because of the breadth and evolving interpretations and requirements of these laws, the narrowness of available statutory and regulatory exemptions, and the wide array of U.S.

and international authorities with overlapping regulatory jurisdiction, it is possible that some of our business activities could be subject to challenge under one or more of such laws.

Any action against us alleging violation of these laws, whether brought by law enforcement, regulatory agencies or private qui tam actions brought by individual whistleblowers in the name of the government, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business, even if we successfully defend against those actions.

If any enforcement actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have an impact on our business, including the imposition of significant civil, criminal and administrative sanctions, damages, disgorgement, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, imprisonment, integrity oversight and reporting obligations, contractual damages, reputational harm, diminished profits and future earnings, and curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

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 "We are currently, in the past have been, and in the future may be, subject to substantial litigation that could cause us to incur significant legal expenses, divert management’s attention, and result in harm to our business," above, and "We must comply with the terms and conditions of the Stipulated Order for Permanent Injunction and Equitable Monetary Relief with the U.S.

We may be subject to adverse public opinion.

The pharmaceutical industry often faces adverse publicity, whether from product recalls, pricing controversies, or other political and social issues.

Since our products treat opioid use disorder and are opioid-based, negative public opinion about us, our medications, or the industry, could damage our reputation.

This may limit acceptance of our products, lead to government intervention, or reduce the willingness of third parties to do business with us, ultimately impacting operations, financial condition, and our ability to engage policymakers.

We use hazardous materials in our manufacturing facilities, and any claims relating to the improper handling, storage, release or disposal of these materials could be time-consuming and expensive.

Our operations are subject to complex and increasingly stringent environmental, health and safety laws and regulations in the countries where we operate and, in particular, in the U.K.

where we have manufacturing and R&D facilities.

The costs of compliance with environmental, health and safety laws and regulations are significant.

If an accident or contamination involving pollutants or hazardous substances occurs, an injured party could seek to hold us liable for any damages that result, and any liability could

exceed the limits or fall outside the coverage of our insurance.

We may not be able to maintain insurance with sufficient coverage on acceptable terms, or at all.

Costs, damages and/or fines may result from the presence, investigation and remediation of such contamination at properties currently or formerly owned, leased or operated by us or at off-site locations, including where we have arranged for the disposal of hazardous substances or waste.

In addition, we may be subject to third-party claims, including for natural resource damages, personal injury and property damage, in connection with such contamination, or in some cases for contamination or pollutants at properties we own caused by prior owners.

Indivior has implemented risk mitigation activities at its manufacturing sites to identify and address environmental, health, and safety risks;

however, there can be no assurance that a violation of current or future environmental, health or safety laws or regulations will not occur.

Any violations, even if inadvertent or accidental, or the cost of compliance with any resulting order, fine or liability that may be imposed, could materially adversely affect our business, financial condition, cash flows and results of operations.

Actual costs to exit various businesses may differ materially from our estimates.

We have made various changes to our business and announced estimated exit costs related to those changes, but our estimates of those costs may differ materially from our estimates.

In August, 2025 and October 2025, we announced (i) the restructuring of our research and development and medical affairs organizations, (ii) the discontinuation of sales and marketing of OPVEE, (nalmefene) nasal spray for the emergency treatment of known or suspected opioid overdose , and (iii) the optimization of our Rest of World business, including the cessation of operations and discontinuation of the sale of our products in several markets, including the U.K., Ireland, Sweden, Israel, Finland, and Italy.

Outside the U.S., we will focus on Australia, Canada, France and Germany, which generated 76% of our 2025 Rest of World net revenue.

As a result of these actions, we recognized exit costs of $127 million in 2025, including (i) severance and related employee exit charges, (ii) the consolidation and exit of certain real estate properties, including write-downs of leasehold improvements, fixed assets, and acceleration of leased property restoration costs, (iii) write-downs of intangible assets and inventory, (iv) contract termination and related costs, and (v) consulting services, among others.

Actual costs could differ materially due to a number of factors including local law considerations in various jurisdictions related to employees exiting the business, changes to exit cost estimates for facilities based on greater or lesser demand for certain properties, changes in estimated demand for inventory in various countries and therefore changes to our estimates of inventory write-downs, and the requirements of various third parties including contract counterparties and ministries of health related to our exit and our estimates of exit costs.

To the extent that actual costs differ from our expectations, such differing costs could affect our results of operations.

Most of our pharmaceutical pipeline relies on collaborations with third parties, which may adversely affect the development and sale of our products.

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Our agreements with development partners typically require substantial up-front investments, potential milestone or option payments, and royalties on net sales to the development partner.

For example, through our agreements with multiple collaboration partners, we have aggregate potential financial obligations of up to approximately $98 million upon the completion of all development milestones and additional potential financial obligations of an aggregate of $252 million if all sales milestones are met.

For example, through our agreements with multiple collaboration partners, we have potential development milestone obligations of up to approximately $97 million, and potential sales milestone obligations of $250 million if all sales milestones are met.

Development milestones generally are payable upon the attainment of certain milestones towards and including the approval of a new product and, by definition, would be triggered (if at all) prior to the sale of such products.

Sales milestones are payable upon the attainment of specified commercial sales levels.

Similarly, we have potential obligations of up to $68 million in connection with a Contingent Value Agreement entered into in connection with the acquisition of Opiant Pharmaceuticals, Inc., a Delaware corporation (“Opiant”) based upon future sales of OPVEE reaching certain levels.

See “ Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations —B.

Liquidity and Capital Resources, ” at the caption “ CVR Agreement .” While these payments, if triggered, would require substantial resources, at the same time they reflect increased value of products or potential products as development or sales milestones are attained.

Also, failures by these parties to meet their contractual, regulatory, or other obligations to us or any disruption in the relationships between us and these third parties, could have a material adverse effect on our pharmaceutical pipeline and business.

In addition, our collaborative relationships for R&D and/or commercialization and sales often extend for many years and have given, and may in the future give, rise to disputes regarding the relative rights, obligations and revenues of us and our collaboration partners, including the ownership or prosecution of intellectual property and associated rights and obligations.

While these payments, if triggered, would require substantial resources, at the

same time they reflect increased value of products or potential products as development or sales milestones are attained.

Failures by these parties to meet their contractual, regulatory, or other obligations to us, or any disruption in the relationships between us and these third parties, could have a material adverse effect on our pharmaceutical pipeline and business.

In addition, our collaborative relationships for R&D and/or commercialization and sales often extend for many years and may in the future give rise to disputes regarding the relative rights, obligations and revenues of us and our collaboration partners, including the ownership or prosecution of intellectual property and associated rights and obligations.

This could result in the loss of intellectual property rights or protection, delay the development and sale of potential pharmaceutical products, affect the effective sale and delivery of our commercialized products and lead to lengthy and expensive litigation, administrative proceedings or arbitration.

There is also a trend in the specialty pharmaceutical industry of seeking to “outsource” drug development by acquiring companies with promising drug candidates.

We face substantial competition from historically innovative companies, as well as companies with greater financial resources than us, for such acquisition targets.

In addition, we rely on contract research organizations and other third parties to assist in managing, monitoring and otherwise carrying out our clinical trials, including with respect to site selection, contract negotiation and data management.

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and Clinical Trial Application (CTA) in Europe).

Our failure, or the failure of third parties conducting clinical trials on our behalf,

to comply with these regulations may require us to repeat or redesign clinical trials, which would delay the regulatory approval process or expose us to regulatory sanctions.

Our failure, or the failure of third parties conducting clinical trials on our behalf, to comply with these regulations may require us to repeat or redesign clinical trials, which would delay the regulatory approval process or expose us to regulatory sanctions.

If our clinical trials do not meet regulatory requirements, or if the third parties conducting our clinical trials need to be replaced, our clinical trials may be extended, delayed, suspended or terminated.

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If any of these events occur, we may not be able to obtain regulatory approval for our product candidates or succeed in our efforts to create approved line extensions for our existing products or generate additional useful clinical data in support of these products, which would adversely affect our business, prospects, results of operations and financial condition.

See also Item 1A.

Risk Factors—“ 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.

See also, “ 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,” below.

Clinical trials for the development of products, including our key pipeline products, may be unsuccessful and our product candidates may not receive authorization for manufacture and sale.

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No assurance can be provided that a clinical study will demonstrate that a particular product candidate safely provided hypothesized benefits.

Our lead development products are INDV-2000 (selective orexin-1 receptor antagonist) for which two Phase 1 clinical trials (single and multiple ascending dose studies) have been completed and for which we initiated a clinical Phase 2 proof-of-concept study in the second quarter of 2024;

and INDV-6001 (buprenorphine based LAI) for which we initiated a multiple-dose pharmacokinetic Phase 2 clinical study in the third quarter of 2024.

However, the results from early clinical trials may not be indicative of results obtained in later and larger clinical trials, and therefore these product candidates may fail to show the desired safety and efficacy in later clinical trials despite having progressed successfully through initial clinical testing.

Our lead development products are INDV-6001 (buprenorphine based LAI) for which we initiated and completed multiple-dose pharmacokinetic Phase 2 clinical study in the third quarter of 2024 and in the fourth quarter of 2025, respectively, and INDV-2000 (selective orexin-1 receptor antagonist) for which two Phase 1 clinical trials (single and multiple ascending dose studies) have been completed and for which a

clinical Phase 2 proof-of-concept study was completed in the fourth quarter of 2025.

We expect to announce results of both trials during the first half of 2026.

However, Phase 1 clinical studies involve small groups of subjects and are intended to test the safety of the product under development;

Phase 2 clinical studies involve a larger group of subjects than Phase 1 and are focused on the effectiveness and safety of the product under development.

It is not until Phase 3 that the clinical study typically involves a much larger, more diverse group of subjects and looks not only at the safety and effectiveness of the product under development but also how the product compares to existing treatments.

For that reason, the results from early clinical trials may not be indicative of results obtained in later and larger clinical trials, and therefore these product candidates may fail to show the desired safety and efficacy in later clinical trials despite having progressed successfully through initial clinical testing.

In that case, the FDA or the equivalent regulatory authority in jurisdictions outside the U.S.

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Also, the development process takes many years and can be very expensive.

Many companies in the pharmaceutical industry have suffered significant setbacks in drug development and there can be no guarantee that FDA approval will ultimately be obtained for any given product.

The number and duration of pre-clinical studies and clinical trials that are required vary depending on the product candidate, the indication being evaluated, the trial results and the regulations applicable to the particular product candidate.

Many companies in the pharmaceutical industry have suffered significant setbacks in drug development and there can be no guarantee that FDA approval will ultimately be obtained for any given product.

Such clinical and other studies can be delayed or halted for a variety of reasons, including:

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• insufficient funds to complete the trials.

For example, regulatory approval to conduct clinical studies for one of our non-opioid OUD treatments was delayed due to a clinical hold originating with FDA’s concerns related to a third-party’s product, rather than our own product.

Also, in September 2024, following a Phase II clinical trial that failed to meet its primary endpoint, we made the decision to not exercise our option for AEF0117, a synthetic CB1-specific signaling inhibitor, which we had acquired in June 2021 from the French company Aelis Farma.

We rely on clinical investigators and clinical sites to enroll patients and sometimes third parties to manage our trials and to perform related data collection and analysis.

However, while we can set certain contractual expectations, we may be unable to control the amount and timing of resources that the clinical sites which conduct the clinical testing may devote to our clinical trials.

For example, in September 2024, following a Phase II clinical trial that failed to meet its primary endpoint, we made the decision to not exercise our option for AEF0117, a synthetic CB1-specific signaling inhibitor, which we had acquired in June 2021 from the French company Aelis Farma.

We rely on clinical investigators and clinical sites to enroll patients and conduct the clinical testing and sometimes third parties to manage our trials and to perform related data collection and analysis.

while we can set certain contractual expectations, we may be unable to control the amount and timing of resources that the clinical sites and third parties may devote to our clinical trials.

Our clinical trials also may be delayed or terminated due to the inability of our clinical investigators to enroll enough qualified patients.

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If these clinical investigators, clinical sites or other third parties do not carry out their contractual duties or obligations or fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to their failure to adhere to our clinical protocols or for other reasons, our clinical trials may be extended, delayed or terminated, and we may be unable to obtain regulatory approval for, or successfully commercialize, our product candidates.

The administration of drugs to humans carries the inherent risk of product liability claims whether or not the drugs are actually the cause of an injury.

Additionally, incidents of product misuse may occur.

products to date.

Risks can vary widely based on individual health conditions, demographics, and concurrent medications.

Indivior follows strict regulatory guidelines and quality standards to ensure the safety and efficacy of our products via ongoing monitoring, including post-marketing safety surveillance.

For example, the Company has been named as a defendant in numerous lawsuits alleging that SUBOXONE Film was defectively designed and caused dental injury, and that the Company failed to properly warn of the risks of such injuries.

Financial Statements—Audited Consolidated Financial Statements - Note 16.

Commitments and Contingencies .

These lawsuits and claims followed required revision in the U.S.

to the Prescribing Information and Patient Medication Guide about dental problems reported in connection with buprenorphine medicines dissolved in the mouth to treat opioid use disorder.

This revision was required by the FDA of all manufacturers of these products.

Risk Factors—“ T he FDA, the DEA, or other regulatory agencies may impose limitations or post-approval requirements on approvals for our products ” and " Pro duct liab ility and product recalls could have a ma terial adverse effect on us ," below.

Additionally, simply sponsoring a clinical trial carries with it exposure for other tort liability.

In that case, we could be seen as being at fault because we sponsored the clinical trial and designed the protocol that required that the product be used or procedure be done.

These events, among others, could result in product recalls or additional regulatory controls (including additional regulatory scrutiny and requirements for additional labeling or risk mitigation measures) or product liability claims.

If there is a liability finding, various factors could affect reimbursement of payment by insurers, including (i) the scope of the insurers’ purported defenses and exclusions to avoid coverage, (ii) the outcome of negotiations with insurers, (iii) delays in or avoidance of payment by insurers and (iv) the extent to which insurers may become insolvent in the future.

Additionally our product liability insurance coverage may be inadequate to satisfy liabilities that arise and we may be unable to obtain adequate coverage at an acceptable cost.

This could prevent or limit the development or commercialization of our products.

In addition, the reporting of adverse drug reactions and product quality complaints involving our products, including instances of product misuse, and public rumors about such events could cause our product sales or share price to decline or experience periods of volatility.

These types of events could have a material adverse effect on our business, financial condition, cash flows and results of operations.

We face additional risks as a manufacturer that manufactures pharmaceutical products for others and, in the future, for ourselves.

With the 2023 purchase of our Raleigh Manufacturing Facility , we assumed obligations to manufacture drugs and other products for third parties.

We purchased the Raleigh Manufacturing Facility with a view towards eventually manufacturing some of our products there in order to ensure supply security.

There may also be potential to improve manufacturing costs.

However, before doing so, we will need to (i) perform our obligation under existing contracts and meet related regulatory requirements with respect to those products, and (ii) invest in additional capital equipment and testing before we can secure our long-term supply.

As a result, we face additional risks, and the risks discussed in this report may apply to both our business as well as our activities as a contract manufacturer of products for others.

Onerous contracts .

In connection with our acquisition of the Raleigh Manufacturing Facility, the Company assumed onerous contracts and carries a provision of $6 million.

The facility continues to manufacture products for customers based on the terms of contracts that existed pre-acquisition and the expected costs to fulfill these contracts are in excess of the economic benefits expected to be received by the Company.

We expect the minimum performance period in the onerous contracts to have ended by June 30, 2025.

Expected operating los ses .

In addition to the provision for onerous contracts which we recognized at the time of acquisition, we expect to incur incremental operating costs over the next year for items such

as depreciation of excess capacity, incremental compensation expense from additional headcount, and incremental information technology and other expenses, resulting in expected operating losses for the Raleigh Manufacturing Facility.

Expected investment in capital equipment.

In order to produce Indivior products at the Raleigh Manufacturing Facility , we will need to invest in the build-out of an aseptic syringe filling suite with supporting manufacturing process equipment and warehouse expansion that will need to be qualified, followed by the technology transfer of our manufacturing process to be validated for regulatory approval.

We expect to make capital expenditures of approximately $50 million to $70 million in 2025, primarily to establish and scale manufacturing of SUBLOCADE at the Raleigh Manufacturing Facility.

Any changes to our cost estimates or delays in obtaining regulatory approval of our manufacturing site may increase our expenses or delay our ability to manufacture our own products at the Raleigh Manufacturing Facility and correspondingly delay expected cost savings.

Quality Control and Product Safety.

As a manufacturer of pharmaceutical products for third parties, we are responsible for ensuring the quality, safety, and efficacy of the pharmaceutical products we manufacture.

Any deviations from quality standards or safety concerns could result in FDA enforcement actions, product recalls, legal liabilities, damage to our reputation, and financial losses.

Product Liability and Litigation.

The pharmaceutical industry is susceptible to product liability claims and lawsuits.

Any adverse events, side effects, or alleged defects in the pharmaceutical products we manufacture could result in litigation, regulatory actions, and financial liabilities.

Data Integrity and Record Keeping.

Accurate and compliant recordkeeping is crucial in the pharmaceutical industry.

Any issues related to data integrity or recordkeeping practices may result in regulatory actions, warning letters, or sanctions by the FDA.

Regulatory Changes and Uncertainties.

Our operations are subject to evolving regulatory requirements, policies, and interpretations by the FDA.

Changes in regulations or guidelines could require us to modify our manufacturing processes, quality control measures, or documentation practices, which may result in additional costs or delays.

FDA Inspections and Audits.

We are regularly subject to inspections and audits of our manufacturing facilities by the FDA and other regulators to assess compliance with current Good Manufacturing Practices (cGMPs) and other regulatory standards.

Any deficiencies or non-compliance identified during these inspections could lead to warning letters, import bans, product recalls, or delays in approvals, which could adversely affect our business and reputation.

Risk Factors—" We are subject to ongoing obligations and continued regulatory inspection by the FDA and equivalent foreign regulatory agencies, and we may be subject to penalties and litigation and large incremental expenses if we fail to comply with regulatory requirements or experience problems with our products ," below .

Ability to Secure Supply.

Whether we can achieve our goals of enhancing supply security will depend on whether we can successfully integrate the Raleigh Manufacturing Facility and its workforce into our operations, our ability to install, validate, and secure FDA approval of a new manufacturing line, and our ability to operate the facility efficiently.

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.

A key element of our long-term strategy is to develop or acquire and commercialize a portfolio of other products or product candidates in addition to our current products, through business or product acquisitions.

Because we dedicate only a small portion of our own resources towards proprietary drug discovery, the success of this strategy depends in large part upon the combination of our regulatory, development and commercial capabilities and expertise and our ability to identify, select and acquire approved or clinically enabled product candidates for therapeutic indications that complement or augment our current products, or that otherwise fit into our development or strategic plans on terms that are acceptable to us.

• We are developing INDV-6001 (buprenorphine-based LAI) for the treatment of OUD in collaboration with Alar Pharmaceuticals Inc.

• We are developing INDV-2000 (Selective Orexin-1 Receptor Antagonist), a non-opioid treatment for moderate to severe opioid use disorder.

• In 2023, we completed the acquisition of Opiant, a specialty pharmaceutical company that developed OPVEE for opioid overdose reversal.

See “ Item 1 .Business — Pipeline ,” for more information.

Identifying, selecting and acquiring promising products or product candidates requires substantial technical, financial and human resources expertise.

Efforts to do so may not result in the actual acquisition or license of a particular product or product candidate, potentially resulting in a diversion of our management’s time and the expenditure of our resources with no resulting benefit.

In addition, we face substantial competition from historically innovative companies, as well as companies with greater financial resources than us, for such acquisition targets.

If we are unable to identify, select and acquire suitable products or product candidates from third parties or acquire businesses at valuations and on other terms acceptable to us, or if we are unable to raise the capital required to acquire businesses or new products, our business and prospects will be limited.

In addition, any growth through business development will depend upon us identifying and obtaining product candidates, our ability to develop those product candidates and the availability of funding to acquire, complete the development of, obtain regulatory approval for and commercialize these product candidates.

Doing so is complex and we may not be able to successfully manage the risks or other anticipated and unanticipated problems in connection with an acquisition or in-licensing, and may not be able to realize the anticipated benefits of any acquisition or in-licensing for a variety of reasons, including the possibility that a product candidate proves not to be safe or effective in later clinical trials, a product fails to reach its forecast commercial potential or the integration of a product or product candidate gives rise to unforeseen difficulties and expenditures.

It is common for multiple products and product candidates to be evaluated for the same indication by multiple parties at the same time, and we cannot predict whether the expected commercial potential for our products will come to fruition.

Any failure in identifying and managing these risks and uncertainties effectively would have a material adverse effect on our business, prospects, results of operations and financial condition.

To continue to grow our business over the longer term, we plan to commit resources to product acquisition and in-licensing, product development, clinical trials of product candidates and expansion of our commercial, development, manufacturing and other operations.

Acquisition opportunities that we pursue could materially affect our liquidity and capital resources and may require us to incur additional indebtedness, seek equity capital or both.

Our ability to raise additional capital may be adversely impacted by worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the U.S.

and worldwide resulting from the effects of inflationary pressures, potential future bank failures or otherwise.

In addition, under U.K.

law we must have authority from our shareholders to issue any ordinary shares, including ordinary shares that are part of our authorized but unissued share capital, and we currently have such authorization until May 2025.

An inability to borrow or raise additional

capital in a timely manner and on attractive terms could prevent us from expanding our business or taking advantage of acquisition opportunities and could otherwise have a material adverse effect on our business and growth prospects.

In addition, if we use a substantial amount of our funds to acquire or in-license products or product candidates, we may not have sufficient additional funds to conduct all of our operations in the manner we would otherwise choose.

Moreover, any product candidate we acquire may require additional, time-consuming development or regulatory efforts prior to commercial sale or prior to expansion into other indications, including pre-clinical studies if applicable, and extensive clinical testing and approval by the FDA and applicable foreign regulatory authorities.

All product candidates are prone to the risk of failure that is inherent in pharmaceutical product development, including the possibility that the product candidate will not be shown to be sufficiently safe and/or effective for approval by regulatory authorities.

In addition, we cannot assure that any such products that are approved will be manufactured or produced economically, successfully commercialized or widely accepted in the marketplace or be more effective or desired than other commercially available alternatives.

Any failure in identifying and managing these risks and uncertainties effectively would have a material adverse effect on our business, prospects, results of operations and financial condition, and any unsuccessful effort may require us to write down prior investments.

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.

For example, in March 2023 we acquired Opiant Pharmaceuticals in exchange for $146 million in cash and potential future payments of up to $68 million upon the completion of certain sales milestones pursuant to a contingent value rights agreement.

Financial Statements—Audited Consolidated Financial Statements - Note 18.

Asset Acquisitions.

We also made a number of smaller acquisitions in 2023.

In the future, our ability to acquire additional companies or products synergistic with our current businesses may be limited by antitrust regulators who may be particularly vigilant in our markets because we serve at-risk populations and because we already market several products in the space.

Furthermore, we may have trouble identifying suitable acquisition targets in the future.

Our ability to deliver the expected benefits from any strategic transactions is subject to numerous uncertainties and risks, including our acquisition assumptions;

our ability to integrate personnel, labor models, financial, supply chain and logistics, IT and other systems successfully;

disruption of our ongoing business and diversion of management time;

the need to hire additional management and other critical personnel;

and increasing the scope, geographic breadth and complexity of our operations.

Furthermore, we may finance these strategic transactions by incurring additional debt or raising equity, which could increase leverage or impact our ability to access capital in the future.

We may be subject to adverse public opinion.

The pharmaceutical industry is frequently subject to adverse publicity on many topics, including product recalls and research and discovery methods, as well as political controversy over pharmaceutical pricing, and the impact of novel techniques and therapies on humans, animals, and the environment, among others.

Among our products, we manufacture and market buprenorphine-based medications for the treatment of moderate-to-severe opioid use disorder.

While these medications are indicated to treat opioid use disorder, they are opioids and may be viewed negatively by the public.

Negative publicity about us or our products, about the medications for the treatment of opioid use disorder, or about the industry as a whole, may adversely affect our corporate reputation, which could impact our operations, impair our ability to gain market acceptance for our products or lead to government intervention, which in turn could have an adverse impact on our business, prospects, results of operations and financial condition.

For example, our 2020 settlement with the DOJ created substantial adverse publicity and may have made it more difficult for some to distinguish our company, which works to address the opioid crisis, from those companies that created or exacerbated the opioid crisis.

See “ Item 1 :

Business — Overview .” In announcing the settlement, the DOJ made a point to note that our medicines are opioids.

This and other potential adverse publicity may reduce the willingness of third parties to do business with us, including credit providers and other investors, technology licensors, advocacy organizations, or potential employees, and may harm our ability to engage with policymakers on public policy issues critical to our business.

For instance, in recent years, some state and federal officials were unwilling to meet with us to discuss policy issues while we were under government investigation, as were some third party groups.

Failure to retain key personnel or attract new personnel could have a material adverse effect on us.

On February 27, 2024, we announced that the Company has appointed Joe Ciaffoni, currently an Independent Non-Executive Director of the Company, as Chief Executive Officer.

The terms of his appointment are subject to, and effective upon, the approval by shareholders of a new remuneration policy at the Company’s AGM in May 2025, and there is no assurance that such approval will be obtained.

By mutual agreement, Mark Crossley will be stepping down as Chief Executive Officer and as a Board Director and is expected to remain as CEO until at least the date of the Company’s AGM in May 2025.

If shareholders fail to approve the remuneration policy at the Company’s AGM, there is no assurance that we would be able to secure the services of Mr.

Ciaffoni or others with similar qualifications, which could have a material adverse impact on the business.

In particular, we must compete with other pharmaceutical and life sciences companies to recruit, hire, train and retain sales and marketing personnel as well as research and development personnel.

Competition for such personnel in the pharmaceutical and biotechnology industries is intense, and there can be no assurance that we will be able to recruit or retain such personnel.

We do not carry “key person” insurance.

The loss of the services of any of our key executives or employees could delay or prevent the successful completion of some of our vital activities.

Any employee may terminate his or her employment at any time without notice or with only short notice and without cause or good reason.

The resulting loss of institutional knowledge may have a material adverse effect on our operations and future growth.

We use hazardous materials in our manufacturing facilities, and any claims relating to the improper handling, storage, release or disposal of these materials could be time-consuming and expensive.

Our operations are subject to complex and increasingly stringent environmental, health and safety laws and regulations in the countries where we operate and, in particular, in the U.K.

where we have manufacturing and R&D facilities.

The costs of compliance with environmental, health and safety laws and regulations are significant.

If an accident or contamination involving pollutants or hazardous substances occurs, an injured party could seek to hold us liable for any damages that result, and any liability could exceed the limits or fall outside the coverage of our insurance.

We may not be able to maintain insurance with sufficient coverage on acceptable terms, or at all.

We have developed and implemented a proprietary risk mitigation program to preemptively identify and address environmental, health, safety and security risks;

however, there can be no assurance that a violation of current or future environmental, health or safety laws or regulations will not occur.

Risks Related to Intellectual Property

Failure to obtain and maintain patents and protect other proprietary rights, including in-licenses of such rights from third parties, may adversely affect us.

Our success depends, in large part, on our ability to obtain and maintain patent and other intellectual property protection, particularly for our drug, compound, product, delivery, formulation and methods of treatment technologies and associated manufacturing processes in relation to both our products and our product candidates.

The process of obtaining patents can be lengthy and expensive.

We own, or in-license, several patent rights in the U.S.

and other countries covering certain products and have also developed brand names and trademarks for other products.

We will be able to protect our proprietary rights from unauthorized use by third parties only to the extent that our proprietary technologies and future products are covered by valid and enforceable patents or are effectively maintained as trade secrets or confidential information within the Company.

Our existing patents, and any future patents we obtain, may not be sufficiently broad to prevent others from using our technologies or from developing competing products and technologies.

If third parties disclose or misappropriate our proprietary rights, it may materially and adversely impact our business, prospects, results of operations and financial condition.

Moreover, our ability to obtain and enforce patents and other proprietary rights is critical to our business strategy and success.

The patent positions of many pharmaceutical and life sciences companies are highly uncertain and involve complex legal and factual questions.

In some cases, the legal principles that apply to these cases may be changing or unresolved.

As a result, the validity and enforceability of our patents cannot be predicted with certainty.

In addition, we cannot guarantee that:

• we were the first to make the inventions covered by each of our issued patents and pending patent applications;

• we were the first to file patent applications for these inventions;

• patents will be granted in connection with any of our currently pending or future applications;

• other companies will not independently develop similar or alternative technologies or duplicate any of our technologies by inventing around our claims;

• a third-party will not challenge our proprietary rights, and if challenged that a court will hold that our patents are valid and enforceable;

• any patents issued to us or our collaboration partners will cover our products as ultimately developed, or provide us with any competitive advantages, or will not be challenged by third parties;

• we will develop additional proprietary technologies that are patentable;

• the patents of others will not have an adverse effect on our business.

We also rely on trade secrets and other unpatented confidential information to maintain our competitive position but there can be no assurance that others may not independently develop the same or similar products or technologies, and may also obtain patents and other intellectual property protection for them.

We have sought to protect trade secrets and confidential information in some cases through the provisions of confidentiality and non-use agreements with our employees, consultants, advisers and partners.

Nevertheless, it may not always be possible to prevent the disclosure of our trade secrets and other confidential information or for us to obtain an adequate remedy in the event of unauthorized disclosure or use of such information.

In addition, if our employees, consultants or partners develop inventions or processes independently that may be applicable to our products or technologies under development, such inventions and processes will not necessarily become our property, but may remain the property of those persons or their employers or the persons may be entitled to compensation in respect of those inventions.

Protracted and costly litigation could be necessary to enforce and determine the scope of our proprietary rights.

We have entered into several collaborative arrangements for the development and commercialization of products including with Curia for the production of SUBLOCADE and Aquestive for the production of SUBOXONE Film.

In connection with such arrangements, we have shared certain of our proprietary knowledge with our partners, and it may not be possible or practical to prevent our partners from developing similar or functionally equivalent products.

Any disputes between us and such partners may threaten our ability to continue using such proprietary knowledge and, in turn, could impact our ability to market our products.

We have also engaged in collaborations, sponsored research agreements and other arrangements with academic researchers and institutions, some of which have received and may receive funding from government agencies.

Although we have sought to retain ownership of all intellectual property rights pertaining to inventions that may result from such collaborations, there can be no assurance that governments, institutions, researchers or other third parties will not also attempt to claim certain rights to such inventions.

If we fail to obtain and maintain sufficient intellectual property protection for our current and future products and technologies and if third parties disclose or misappropriate our proprietary rights, our ability to successfully and fully exploit these products and technologies could be adversely affected, which in turn would adversely affect our business, prospects, results of operations and financial condition.

We may incur substantial costs as a result of litigation or other proceedings relating to patents and other intellectual property rights, and we may be unable to protect our rights to, or commercialize our products.

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These lawsuits are expensive and, as with the SUBOXONE ANDA litigation, could cost the Company several million dollars per year.

They are time-consuming and could divert management’s attention from the day-to-day operation of our business .

They are time-consuming and could divert management’s

attention from the day-to-day operation of our business .

In addition, there is a risk that a court will decide that these patents are not valid or not infringed and that we do not have the right to prevent the other party from using the patented subject matter.

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Reddy’s Laboratories (“DRL”) and Alvogen pursued claims for wrongful injunction damages, and further asserted antitrust counterclaims against the Company after the Company sought to enforce particular patent claims against DRL and Alvogen.

The Company reached settlements with DRL and

Alvogen in 2022 and 2023, respectively.

Financial Statements—Audited Consolidated Financial Statements - Note 11.

Accrued Litigation Settlement Expenses .

A third-party may claim that we or our manufacturi ng or commercialization partners are using inventions covered by the third-party’s patent rights, or that we or such partners are infringing, misappropriating or otherwise violating other intellectual property rights, and may go to court to stop us from engaging in our ordinary course operations and activities, including manufacturing or selling our products.

There is a risk that a court could decide that we or our partners are infringing, misappropriating or otherwise violating third-party patents or other intellectual property rights, which could have a material adverse effect on our business and results of operations.

In addition, such litigation diverts the attention of management and development personnel.

The Company reached settlements with DRL and Alvogen in 2022 and 2023, respectively.

We may initiate or defend legal proceedings relating to our patents alongside a collaborator or third-party with an interest or right in the relevant patents.

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Any such patent application may have priority over our or our licensors’ patents or applications and could further require us to obtain rights to patent rights covering such subject matter.

In the U.S., if another party has filed a patent application on inventions similar to those of the Company, we may have to participate in an interference or deviation proceeding declared by the USPTO to determine the priority of invention in the U.S.

In the U.S., if another party has filed a patent application on inventions similar to those of the Company, we may have to participate in an interference or derivation proceeding declared by the US.

Patent and Trademark Office to determine the priority of invention in the U.S.

The costs of these proceedings could be substantial, and it is possible that such efforts would be unsuccessful, resulting in a loss of our U.S.

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The cost to us of any patent litigation or other proceedings, even if resolved in our favor, could be substantial.

Some of our competitors may be able to sustain the costs of complex patent and other intellectual property litigation more effectively than we can because they have substantially greater resources than the Company.

Some of our competitors may be able to sustain the costs of complex patent and other intellectual property litigation more effectively than we can because they have substantially greater

resources than the Company.

In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue its operations.

Any of the foregoing could have a material adverse effect on our business, prospects, results of operations and financial condition.

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.

Filing, prosecuting and defending patents relating to all of our product candidates and technologies throughout the world would be prohibitively expensive.

Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products, and further, may export otherwise infringing products to territories where we have patent protection but where enforcement is more difficult.

These products may compete with our future products in jurisdictions where we do not have any issued patents and our patent claims or other intellectual property rights may not be effective or sufficient to prevent them from so competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions.

The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, which could make it difficult for us to stop infringement of our patents or marketing of competing products in violation of our proprietary rights generally.

Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert efforts and attention from other aspects of our business, which could adversely affect our operations and financial condition.

Moreover, our patent rights can be challenged in post-grant or inter partes review.

For example, our patents for SUBLOCADE were challenged in the EU patent office under two separate European opposition proceedings.

However, both of those proceedings were dismissed.