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Item 1. Business

2026-02-26 compared with 2025-03-03 · 375 added, 555 removed, 524 unchanged (64% of the section changed)

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (“SUDs”).

As a pioneer in developing evidence-based treatments for opioid use disorder (“OUD”), our vision is that the millions of people across the globe suffering from SUDs will have access to evidence-based treatment to change lives.

As a leader in addiction treatment, Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease.

Indivior Pharmaceuticals, Inc.

and its subsidiaries (together, "Indivior" or the "Company") is the market leader in long-acting injectable medications for opioid use disorder (OUD).

Indivior is focused on delivering evidence-based pharmacotherapies for OUD and is committed to advancing the neurobiological understanding of OUD as a chronic, relapsing, but treatable brain disease.

For more than 25 years, Indivior has led innovation in addiction medicine, developing differentiated therapeutic solutions that support long-term patient recovery, expand access to care, and drive sustainable value for patients, healthcare systems and stockholders.

Headquartered in the U.S.

in Richmond, Virginia, Indivior employs more than 1,000 individuals globally and its portfolio of products is available in more than 30 countries worldwide.

in Richmond, Virginia, Indivior and its portfolio of products is available primarily in the U.S.

with additional products available in Canada, Australia, France, and Germany.

Our core products include the following approved treatments:

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• SUBOXONE Film (buprenorphine and naloxone sublingual film);

• SUBOXONE Tablet (buprenorphine and naloxone sublingual tablets);

• SUBUTEX Tablet (buprenorphine sublingual tablets),

all of which are treatments for OUD, and

• OPVEE (nalmefene) nasal spray for opioid overdose reversal.

Product availability varies across the countries in which Indivior treatments are available, including in terms of dosage form, strength and indication.

The Company sells its products in the U.S.

and in other selected areas of the world, such as much of Europe, Canada, Australia and through distribution partners in other parts of the world.

Our core geographic market (based on the country where the sale originates) is the U.S., which accounted for 85%.

83%, and 81% of net revenues for the years ended December 31, 2024, 2023, and 2022, respectively.

both of which are treatments for OUD.

Product availability varies across the countries in which Indivior treatments are available, including in terms of dosage, strength and indication.

Our core geographic market (based on the country where the sale originates) is the U.S., which accounted for 85%, 85%, and 83% of net revenues for the years ended December 31, 2025, 2024, and 2023, respectively.

In the U.S., we sell only SUBLOCADE and SUBOXONE Film.

Corporate History

Our business was initially developed and managed as a separate division of Reckitt Benckiser Group PLC (“RB” and, together with its subsidiaries, the “RB Group”), a public limited company incorporated under the laws of England and Wales.

Indivior PLC was incorporated on September 26, 2014, for the purpose of acquiring the specialty pharmaceutical business unit from RB (the “Demerger”).

Following the Demerger, which was effective on December 23, 2014, Indivior PLC has operated as a standalone business.

Following the Demerger, which was effective on December 23, 2014, Indivior PLC operated as a standalone business.

On December 11, 2025, our stockholders approved a plan to change our domicile to the U.S.

On January 23, 2026, Indivior Pharmaceuticals, Inc., a corporation formed in Delaware on October 28, 2025 (“Indivior Pharmaceuticals”), became the ultimate parent company of Indivior PLC, a public company limited by shares incorporated under the laws of England and Wales (“Indivior PLC”), and its subsidiaries pursuant to a court-approved scheme of arrangement under Part 26 of the U.K.

Companies Act 2006 (the “Scheme of Arrangement”) as part of Indivior PLC’s previously announced intention to change its corporate domicile to the United States (the “U.S.

Domestication”).

Pursuant to the Scheme of Arrangement, each ordinary share in the capital of Indivior PLC was cancelled.

In consideration for this cancellation, each stockholder received one share of common stock, par value $0.001 per share, of Indivior Pharmaceuticals, Inc.

for every ordinary share they previously held in Indivior PLC.

After the delivery of the order of the High Court of Justice in England and Wales sanctioning the Scheme of Arrangement to the Registrar of Companies in England and Wales, and after the close of market trading on January 23, 2026, the Scheme of Arrangement became effective and binding on all stockholders of Indivior PLC and Indivior PLC became a wholly-owned subsidiary of Indivior Pharmaceuticals, Inc., thereby completing the U.S.

Domestication.

After this order, Indivior PLC became Indivior Limited.

Previously, the ordinary shares of Indivior PLC were listed on the Nasdaq Global Select Market (“Nasdaq”) and registered pursuant to Section 12(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) prior to the U.S.

Domestication.

The issuance of shares of common stock of Indivior Pharmaceuticals, Inc.

pursuant to the Scheme of Arrangement was exempt from registration under Section

3(a)(10) of the Securities Act of 1933, as amended (the “Securities Act”).

Further, pursuant to Rule 12g-3(a) under the Exchange Act, Indivior Pharmaceuticals, Inc.

is the successor issuer to Indivior PLC and Indivior Pharmaceuticals, Inc.'s common stock is therefore deemed to be registered under Section 12(b) of the Exchange Act.

Because the U.S.

Domestication was completed after December 31, 2025, the financial statements included herein are those of Indivior PLC.

Domestication will be accounted for as a common-control transaction in Q1 2026 and the historical financial statements of Indivior PLC will become the historical financial statements of Indivior Pharmaceuticals, Inc.

The corporate reorganization will have no impact to historical revenues, expenses, assets, liabilities, or cash flows.

Treatment of OUD

The treatment of OUD as a therapeutic area emerged in the early 1920s.

government’s efforts to address OUD through supply regulation and control, and to address public health concerns through scientific innovation, influenced a gradual shift in research interest towards developing a treatment for OUD.

In 1966, RB led the breakthrough discovery of buprenorphine and developed, in partnership with the U.S.

National Institute on Drug Abuse (“NIDA”), buprenorphine for the treatment of OUD.

A significant breakthrough in the treatment of OUD occurred in the US during the 1960s with the expansion of methadone treatment and the creation of opioid treatment programs.

In 1966, Reckitt & Colman (which would become RB) led the breakthrough discovery of buprenorphine.

Throughout the 1970s and 1980s, Reckitt & Colman provided buprenorphine to scientists studying new therapeutic options for OUD.

In 1994, a Cooperative Research and Development Agreement (CRADA) was signed between Reckitt & Colman and the U.S.

National Institute on Drug Abuse (“NIDA”) to develop a buprenorphine and a buprenorphine/naloxone transmucosal medication for the treatment of OUD.

SUBUTEX Tablet (buprenorphine sublingual tablet) was our first approved product specifically indicated for the treatment of OUD.

SUBUTEX Tablet was launched in France in February 1996 by Schering-Plough, which licensed the global marketing rights to the buprenorphine products from RB Group.

SUBUTEX Tablet first received marketing approval in France in July 1995 and was subsequently launched there in February 1996 by Schering-Plough under license from Reckitt & Colman.

Shortly thereafter, SUBUTEX Tablet was approved in additional EU countries.

SUBOXONE Tablet (buprenorphine/naloxone sublingual tablet) was approved across the EU by the EMA in September 2006.

In the U.S., the enactment of the Drug Addiction and Treatment Act of 2000 (“DATA 2000”) was a significant development in the history of addiction treatment.

Previously, treatment options for OUD in the U.S.

were limited:

either abstinence-based programs that have a high rate of relapse, or methadone clinics (the only medication-assisted treatment option).

Methadone clinics in the U.S.

provide daily dosing and may be unpopular with opioid-dependent individuals owing to inconvenience and the significant societal stigma associated with methadone.

As a result, many opioid-dependent individuals remained untreated.

Under DATA 2000, office-based physicians who had completed appropriate training were able to obtain a federal waiver to treat a limited number of opioid-dependent patients with medications specifically approved by the U.S.

Food and Drug Administration (FDA) for the treatment of OUD, and to prescribe and/or dispense these medications in their office-based settings.

By permitting treatment for OUD in the privacy of physicians’ offices with take-home doses, DATA 2000 was significant in creating access to treatment and beginning to treat OUD as a medical condition like other chronic diseases.

In December 2022, Congress enacted the Mainstreaming Addiction Treatment Act (MAT Act) which eliminated the requirement for a health care practitioner (HCP) to apply for a separate waiver through the Drug Enforcement Administration (DEA) to dispense certain treatments (including buprenorphine) for maintenance or detoxification of patients with OUD.

Indivior believes the elimination of these requirements as part of this legislation will help to normalize the view of addiction as a chronic brain disease and expand access to evidence-based buprenorphine treatment.

The Company supports efforts to encourage more HCPs to provide medication for OUD.

Indivior Global Integrity & Compliance Program

Indivior has developed and maintained a Corporate Compliance function and Program dating back to before its demerger from RB Group.

It has since undergone continuous learning and evolution of its capabilities, including:

• hiring an executive committee level Chief Integrity and Compliance Officer in 2018 who reports directly to the CEO and also to the Board;

• using external consultants and relevant best practice standards and benchmarks to evaluate and assist with evolution of its Global Integrity & Compliance Program;

• accelerating the build-out of its updated Integrity & Compliance team structure, including hiring additional credentialed personnel.

This team now includes more than 20 professionals who have established and support administration of the defined and communicated “Indivior Global Integrity & Compliance Program Framework” which is based on the elements of an effective compliance program as defined by governing authorities.

Our Integrity & Compliance team supports the business and functions in the assessment and mitigation of healthcare compliance risks and co-leads with the Legal team compliance with our obligations under the Government Agreements (i.e., CIA, DOJ Compliance Measures, and the FTC Order.

It is responsible for administering our Code of Conduct and related healthcare compliance policies, procedures and guidance with integrated controls.

In addition, it works to ensure an appropriate tone at the top, promotion of a "speak-up" culture, develops various integrity and ethics initiatives, including Integrity & Compliance team and business-led risk monitoring, educates on relevant risks to help support strong risk monitoring, and is responsible for administering the Company’s Global Integrity & Compliance Program , together with the executive committee who are the members of the Indivior Compliance Committee.

Product Development

Launch of SUBUTEX Tablets, SUBOXONE Tablets, and SUBOXONE Film in the U.S.

The FDA approved SUBUTEX Tablet (buprenorphine) and SUBOXONE Tablet (buprenorphine/naloxone) in October 2002 and we launched sales of these products in the U.S.

Subsequently, in August 2010, the FDA approved SUBOXONE Film (buprenorphine/naloxone) sublingual film, which dissolves more quickly than SUBUTEX and SUBOXONE Tablets.

The FDA approved SUBUTEX Tablet and SUBOXONE Tablet for the treatment of OUD in October 2002 and both products were launched in the U.S.

Subsequently, in August 2010, the FDA approved SUBOXONE Film (buprenorphine/naloxone sublingual film).

We discontinued the U.S.

distribution of

SUBUTEX Tablets in 2011 and SUBOXONE Tablets in 2013.

distribution of SUBUTEX Tablets in 2011 and SUBOXONE Tablets in 2013.

In 2020, the Company’s U.S.

sales force ceased promoting SUBOXONE Film as part of the Resolution Agreement with the Department of Justice (“DOJ”), discussed below, and ceased all detailing of the product in that year, though it remains available for sale.

Our SUBOXONE Film product faces four generic competitors in the U.S., and a fifth is expected in early 2025.

Despite the launches of these generic formulations of tablets and film and branded competition, SUBOXONE Film has maintained a share of the buprenorphine-based OUD treatment market (by mg volume) of approximately 16% in 2024.

Launch of SUBLOCADE in the U.S.

The FDA approved SUBLOCADE (buprenorphine extended-release) injection for subcutaneous use in 2017 and we launched sales of this product in 2018.

As the first long-acting buprenorphine-based injectable approved by the FDA for the treatment of moderate to severe OUD, SUBLOCADE became the largest product by net revenue for the Company by the second quarter of 2022.

Approval and Launch of OPVEE for Overdose Reversal in the U.S.

In May 2023, the FDA approved OPVEE (nalmefene) nasal spray for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression .

OPVEE (nalmefene) nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present.

OPVEE (nalmefene) nasal spray is not a substitute for emergency medical care.

We acquired OPVEE as part of our acquisition of Opiant Pharmaceuticals, discussed below.

We began marketing OPVEE in the U.S.

in October 2023.

In September 2023, we were awarded a contract by the U.S.

Biomedical Advanced Research and Development Authority (BARDA) (i) for the procurement of finished, packaged OPVEE held as vendor-managed inventory as a medical countermeasure in the event of a synthetic opioid community or mass casualty event, and (ii) to support FDA-required post-marketing requirement studies, a three-year stability study to support shelf-life extension, and real world evidence studies.

This funding covers technical expertise for further clinical development and regulatory approval of OPVEE for use in children under 12 years of age.

The contract also has an initial purchase and options for purchases and delivery of OPVEE over another 9 years at guaranteed pricing through 2033.

Product delivered pursuant to the contract is expected to become part of the U.S.

Strategic National Stockpile, which is the U.S.' national repository of antibiotics, vaccines, chemical antidotes, antitoxins, and other critical medical supplies.

The role of the U.S.

Strategic National Stockpile is to supplement state and local supplies during public health emergencies.

Launch of PERSERIS in the U.S.

The FDA approved PERSERIS as the first once-monthly subcutaneous extended-release injectable suspension of risperidone indicated for the treatment of schizophrenia in adults in 2018.

We launched commercial sales of PERSERIS in the U.S.

However, on July 9, 2024, the Company announced that it would immediately cease all promotion and marketing activities related to PERSERIS.

The Company believed this action was in the best interests of shareholders due to the highly competitive market and impending changes that were expected to intensify payor management in the treatment category in which PERSERIS participates.

Analysis of forthcoming changes suggested that there was no longer a path forward for PERSERIS that was financially viable.

Product Availability Outside the U.S.

In Europe, generic versions of the SUBUTEX Tablets and SUBOXONE Tablets have been available since 2010 and 2018, respectively.

Despite strong competition, our Group’s total share of oral buprenorphine medication-assisted treatment ("BMAT") (by mg volume) remained significant at 50%, 51%, and 49% in 2024, 2023, and 2022, respectively.

In Canada, our SUBOXONE Tablets product faces two

generic competitors.

In addition, we face competition from branded oral buprenorphine-based tablets and historically well-established methadone oral formulations.

We distribute SUBLOCADE (under the name SUBUTEX Prolonged Release in Europe) primarily in the U.S., Australia, Canada, Finland, Israel, and Sweden.

We distribute SUBOXONE Film primarily in the U.S., Australia, Canada, Finland, Israel, Italy, Malaysia, and Sweden.

We distribute SUBOXONE Tablets primarily in Belgium, Canada, Germany, and the U.K, and SUBUTEX Tablets primarily in Australia, France, Germany, Israel, Norway, Switzerland, and the U.K.

The FDA approved SUBLOCADE (buprenorphine extended-release injection for subcutaneous use ) in November 2017 and we launched sales of this product in 2018.

As the first monthly buprenorphine-based injectable formulation of buprenorphine approved by the FDA for the treatment of moderate to severe OUD, SUBLOCADE became the largest product by net revenue for the Company by the second quarter of 2022.

Product Availability

We distribute SUBLOCADE primarily in the U.S., Australia, and Canada.

We distribute SUBOXONE Film primarily in the U.S., Australia, and Canada.

We distribute SUBUTEX Tablets primarily in Australia, France, and Germany, and continue to distribute SUBOXONE Tablets on a transition basis in a limited number of countries.

Development Pipeline

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The exclusion did not pertain to the rest of the Company and did not limit access to our medications for patients in the U.S.

Under the terms of the agreements, DOJ dismissed all charges in the 2019 indictment against the rest of the Company and its subsidiaries and the Company agreed to make payments to federal and state authorities totaling $600 million (plus applicable interest of 1.25% on a portion of that total amount).

Pursuant to the resolution agreement, aggregate payments of $263 million (including interest) have been made through December 31, 2024.

An additional payment of $52 million was made in January 2025 and two annual installments of $50 million plus interest will be due in January 2026 and 2027, with the final installment of $200 million plus interest due in December 2027.

As part of the resolution, the Company and Indivior Inc.

agreed to significant compliance and reporting obligations under the Resolution Agreement with DOJ and a stipulated injunction with the FTC, and Indivior Inc.

agreed to a Corporate Integrity Agreement (“CIA”) with the U.S.

Department of Health and Human Services Office of Inspector General (HHS-OIG”).

See (i) “ Item 1A.

Risk Factors— ” Compliance with the terms and conditions of our Corporate Integrity Agreement, the Resolution Agreement with the U.S.

Attorney’s Office for the Western District of Virginia and the U.S.

Department of Justice’s Consumer Protection Branch, and the Stipulated Order for Permanent Injunction and Equitable Monetary Relief with the FTC, requires significant resources and management time and, if we fail to comply, we could be subject to criminal charges, penalties, or, under certain circumstances, excluded from government healthcare programs, which would materially adversely affect our business , ” (ii) Item 8 .

Financial Statements—Audited Consolidated Financial Statements - Note 11.

Accrued Litigation Settlement Expenses for more information.

We have filed copies of the Resolution Agreement, the Corporate Integrity Agreement, and the Stipulated Order for Permanent Injunction and Equitable Monetary Relief between the FTC and Indivior Inc.

as Exhibits 10.2, 10.3, and 10.4, respectively, to this annual report.

We have complied and continue to comply with our reporting obligations under each of the agreements and our obligations to make investments in our Global Integrity & Compliance Program to promote compliance and drive continuous learning and evolution of an effective compliance program .

We expect to complete our obligations under the CIA later this year.

Recent Developments

Transition of Primary Listing to Nasdaq

Effective June 27, 2024, we transitioned our primary stock exchange listing to Nasdaq from the London Stock Exchange ("LSE").

We continue to have a secondary listing on the LSE where our ordinary shares trade on the Equity Shares (Transition) category.

As part of the resolution, the Company and/or Indivior Inc.

agreed to significant compliance and reporting obligations under (i) the Resolution Agreement with DOJ, (ii) a Corporate Integrity Agreement (“CIA”) with the U.S.

Department of Health and Human Services Office of Inspector General (HHS-OIG”), and (iii) a stipulated injunction with the FTC.

We completed our obligations under the CIA in July 2025 and await confirmation from HHS-OIG.

The Company satisfied its remaining obligations under the Resolution Agreement in November 2025.

The FTC Order expires in November 2030.

2025 Developments

CEO and Executive Transitions

On February 27, 2025, Joseph Ciaffoni was appointed CEO and on May 8, 2025, Mr.

Ciaffoni formally succeeded Mark Crossley as CEO of the Company after shareholders approved his appointment.

Ciaffoni also serves on our Board of Directors.

• In May 2025, the Company hired Patrick Barry as Chief Commercial Officer;

• In July 2025, the Company hired Vanessa Procter as EVP for Corporate Affairs;

Label Expansion for SUBLOCADE

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for SUBLOCADE including a rapid initiation protocol and alternative injection sites.

Healthcare providers can now initiate treatment with SUBLOCADE after a single dose of transmucosal buprenorphine and a one-hour observation period to confirm tolerability.

Also, SUBLOCADE can now be administered subcutaneously in the abdomen, thigh, buttock, or back of the upper arm, offering patients and healthcare providers increased flexibility in treatment administration.

These FDA label changes can provide important benefits for patients and healthcare providers.

Rapid initiation may lessen some of the practical obstacles to treatment induction, which may increase the likelihood that patients and providers will start therapy quickly, thereby shortening the time to achieve SUBLOCADE's therapeutic levels that provide continuous buprenorphine concentrations above 2ng/mL.

Rapid initiation may lessen some of the practical obstacles to treatment induction.

Additionally, the ability to select a different injection site may provide patients more flexibility so that they may be inclined to continue their treatment.

More options for healthcare providers to administer SUBLOCADE will streamline the course of treatment and improve integration into different healthcare environments.

Share Repurchase Programs

On November 17, 2023, Indivior commenced a share repurchase program of up to $100 million, which was completed on August 2, 2024.

The Company repurchased and canceled 5,944,547 ordinary shares at an average purchase price of approximately $16.96.

The cost was approximately $101 million, which includes directly attributable transaction costs.

On July 25, 2024, Indivior announced a new non-discretionary $101 million share repurchase program that commenced on August 5, 2024, which was completed on January 31, 2025.

The Company repurchased and canceled 9,415,726 ordinary shares as part of this program, equivalent to approximately 6.4% of diluted shares outstanding, at an average purchase price of approximately $10.71.

Refinancing of Long-Term Debt

On November 4, 2024, we repaid the outstanding balance under our existing credit agreement and announced that our wholly-owned subsidiary, RBP Global Holdings Limited had entered into a Note Purchase Agreement with Piper Sandler Finance LLC as agent and certain purchasers for the issuance of up to $400 million of senior secured notes, comprised of a $350 million of term notes and up to $50 million of variable notes at any time outstanding, (the “Note Purchase Agreement”).

Proceeds from the new term notes were used to fully repay the exiting term loan and pay transaction fees and expenses, and will also be used for general corporate purposes.

Management 's Discussion & Analysis — Liquidity and Capital Resources .

More options for healthcare providers to administer SUBLOCADE may streamline the course of treatment and improve integration into different healthcare environments.

For more information, see " Indivior Products — SUBLO CADE ," below.

Cancellation of London Stock Exchange Listing

Effective June 27, 2024, we moved our primary stock exchange listing to Nasdaq from the London Stock Exchange ("LSE").

We continued to have a secondary listing on the LSE where our ordinary shares traded on the Equity Shares (Transition) category until July 24, 2025, after which we cancelled our LSE listing.

Restructuring of Research & Development and Medical Affairs organizations

In August 2025, we announced that we would restructure our Research & Development and Medical Affairs organizations.

This included the closure of three related locations.

Rest of World Optimization

In October 2025, we announced that we would cease operations and discontinue the sale of our products in several markets, including the U.K., Ireland, Sweden, Israel, Finland, and Italy.

Our plan is to maximize the potential of our business in Canada and Australia;

to maintain operations in France;

and to continue to sell product without local operations in Germany.

We will continue to manufacture the active pharmaceutical ingredient at our Fine Chemical Plant in Hull, U.K., and will retain employees in Slough and Hull who support our U.S.

business and remaining business outside the U.S.

Equity Index Inclusion

The Company's shares were included in the U.S.

Russell 2000 and 3000 indices on June 30, 2025, and the S&P SmallCap 600 index on December 22, 2025.

Change of Domicile

As noted above, the Company changed its domicile from the U.K.

effective after the close of business on January 23, 2026.

Industry Overview

Substance Use and its Impact

According to the United Nations Office on Drugs and Crime World Drug Report 2022, World Drug Report 2024, there number of people who use drugs globally has risen to 292 million in 2022, a 20% increase over 10 years.

The United Nations Office on Drugs and Crime (UNODC) World Drug Report 2025 estimates that 316 million people worldwide used drugs in 2023, marking a 28% increase over the past decade—a rise that exceeds global population growth and signals a higher prevalence of drug use.

In the same year, 64 million individuals were living with a substance use disorder (SUD), reflecting a 13% increase over the last 10 years.

Opioids remain the deadliest category of drugs, responsible for about two-thirds of drug-related deaths, primarily due to overdoses.

Despite this burden, only 1 in 12 people with SUD received any form of treatment in 2023, with access rates even lower in certain regions and among women.

People who use drugs regularly are likely to experience negative health consequences.

They are also more at risk of contracting infectious diseases such as HIV and hepatitis C, and to experience overdose and

suffer premature death.

Furthermore, an association exists between SUD and co-occurring or comorbid mental health disorders (for example, depression, anxiety or psychosis).

They are also more at risk of contracting infectious diseases such as HIV and hepatitis C, and to experience overdose and suffer premature death.

The association between mental health and SUD also reflects bidirectional risks and vulnerabilities, to the extent that mental health disorders (e.g., depression, anxiety or psychosis) can increase vulnerability to drug use to alleviate symptoms of those disorders, such as dysphoria or emotional distress.

At the same time, SUD may increase the risk of developing a mental disorder.

There is also an association between SUD and socioeconomic disadvantage, low educational attainment, increased difficulty in finding and remaining in employment, and financial instability and poverty.

World Health Organization’s (WHO) Global Status Report on Alcohol and Health and Treatment of Substance Use Disorders published in June 2024 reported that 2.6 million deaths per year globally were attributable to alcohol consumption, accounting for 5% of all deaths, and 0.6 million deaths to psychoactive drug use.

The threat SUD poses to global health has long been recognized, and as such strengthening the prevention and treatment is included in the United Nations’ Sustainable Development Goals for 2030.

Overdose deaths continue to be significant in the U.S.

According to the latest data from the U.S.

Center for Disease Control & Prevention (CDC) there were 97,000 fatal overdoses over the previous 12-month period ending July 2024 of which 67,952 were linked to natural and synthetic opioids

Substance Use Disorder:

Substance Use Disorder ("SUD”) has been described as a “medical disorder that affects the brain and changes behavior.” Various substances may be involved including alcohol, illicit drugs, prescription medications, and even some over-the-counter medicines.

SUD has been described as a “medical disorder that affects the brain and changes behavior.” Various substances may be involved including alcohol, illicit drugs, prescription medications, and even some over-the-counter medicines.

The National Institute on Drug Abuse ("NIDA”), the Substance Abuse and Mental Health Services Administration ("SAMHSA") and the National Institutes of Health ("NIH”) all describe SUD as a long-term and relapsing condition characterized by the individual compulsively seeking and using drugs despite adverse consequences.

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These diseases are lifelong conditions that require continual effort to manage.

Symptoms will likely return during periods where treatment compliance is low or absent, and symptoms will likely diminish when compliance to treatment begins again in earnest.

In 2023, 48.5 million people aged 12 or older (or 17%) had a substance use disorder (SUD) in the past year, including 28.9 million who had an alcohol use disorder (AUD), 27.2 million who had a drug use disorder (DUD), and 7.5 million people who had both an AUD and a DUD, according to SAMHSA’s 2023 Survey on Drug Use and Health.

Symptoms will likely return during periods when treatment compliance is low or absent, and symptoms will likely diminish when compliance to treatment begins again in earnest.

in 2024, 48.4 million people aged 12 or older (or 16.8%) had a SUD in the past year, including 27.9 million people who had an alcohol use disorder (AUD), 28.2 million people who had a SUD, and 7.7 million people who had both an AUD and a SUD, according to SAMHSA’s 2024 Survey on Drug Use and Health.

There is no single cause of SUD;

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The prevailing view is that no one thing can predict someone’s risk of developing a SUD—rather, the interaction of the person’s unique biology and their environment influences how the drug will impact a person’s susceptibility to becoming addicted.

Opioid Use Disorder

Opioid Use and Opioid Use Disorder (OUD)

Opioids are a major concern in many countries because of the severe health consequences associated with their use, including non-fatal and fatal overdose.

OUD is a growing global public health crisis which still carries significant stigma in many countries.

OUD is often perceived as a moral failing and sign of personal weakness rather than a chronic and relapsing disease affecting the brain that can be managed and responds to treatment.

As a consequence, we believe coherent action to deal with sufferers and addiction is generally lacking.

According to the United Nations' World Drug Report 2024, an estimated 60 million people used opioids in 2022, representing 1% of the global population.

In 2022, opioid use in North America remains high, with 3% of the adult population reporting past-year use (9 million users).

Opioid use in the U.S.

remains high:

among people aged 12 or older in 2024, 2.7% (or 7.8 million people) misused opioids in the past year.

In 2024, 1.7% of people aged 12 or older (or 4.8 million people) had a past year OUD.

Unfortunately, only 17.0% (or 818,000 people) received medication for opioid use disorder (MOUD) in the past year indicating that OUD still carries significant stigma and is often perceived as a moral failing and sign of personal weakness rather than a chronic and relapsing disease that can be managed and responds to treatment.

In addition, the number of deaths from opioid overdose in the U.S.

continues to remain high, twice the level just a decade ago.

The majority of opioid-related overdose deaths in the U.S.

are now the result of fentanyl being ingested as a substitute for heroin or with drugs such as cocaine and methamphetamine that had been adulterated, or “cut,” with the opioid.

The 12-month-ending provisional number of reported opioid overdose deaths as of August 2025 was approximately 47,000, which represents approximately 64% of all drug overdose deaths.

Opioid-related overdose deaths in the U.S.

are primarily driven by synthetic opioids such as fentanyl representing 96% (45,000) of all opioid overdose fatalities as a result of fentanyl being ingested as a substitute for heroin or with drugs such as cocaine and methamphetamine that had been adulterated, or “cut,” with the opioid.

Fentanyl is 30 to 50 times more potent than heroin and can cause rapid and profound respiratory depression.

Individuals may not be aware that they have been exposed to fentanyl-laced drugs including heroin, prescription opioids, or psychostimulants.

Against the context of the dramatic rise in deaths from opioid overdose, Indivior is doing more to understand the interaction between fentanyl and buprenorphine.

According to a peer-reviewed study conducted by the University of Leiden in Leiden, Netherlands and completed in 2019, sustained high-plasma concentrations of buprenorphine (similar to those provided by SUBLOCADE at steady-state) significantly reduced fentanyl-induced respiratory depression in opioid-tolerant participants.

The European market is smaller than the U.S.

market with an estimated 860,000 high-risk opioid users, according to the European Union Drugs Agency European Drug Report 2024.

The report also found that opioid use was reported as the main reason for entering specialist drug treatment by 63,000 clients in 2022, representing 25% of all those entering drug treatment in Europe.

According to the Australian Institute of Health and Welfare, in 2023 on an average day, 53,300 clients received pharmacotherapy treatment for their OUD across Australia.

A pproximately 10% of Canadian adults who used opioid medications, or 351,000 persons, reported problematic use, a ccording to a 2022 report from Statistics Canada, and approximately 153,000 are in treatment, according to data from IQVIA (a health information provider).

In Australia in 2024, on an average day, 56,256 clients received pharmacotherapy treatment for their OUD across Australia, according to Australia's 2024 National Opioid Pharmacotherapy Statistics Annual Data Collection.

There is increasing awareness among healthcare providers in Australia of the misuse of opioid analgesics and the need for treatment.

Recent policy changes to address this concern in Australia include re-classifying products containing codeine so that they must be dispensed by a pharmacist rather than being available over the counter.

Similarly, according to the Canadian Centre on Substance Use and Addiction, approximately 10% of Canadian adults who used opioid medications, or 351,000 persons, reported problematic use, and approximately 153,000 are in treatment according to data from IQVIA (a health information provider).

Outside of the U.S., Canada, and Australia, approximately 269 million people aged 15 to 64 suffer from drug use disorders or drug dependence, according to the United Nations Office on Drugs and Crime.

Treatment services are generally very underdeveloped (with the exception of Australia and New Zealand), the key challenge being to convince governments to treat addiction as a chronic medical disease rather than a social disorder.

Treatment for Opioid Use Disorder

Medication for opioid use disorder ("MOUD") is the use of medications, in combination with counseling and behavioral therapies, to provide a “whole patient” approach to the treatment of OUD.

Medications used in MOUD are approved by the FDA and MOUD programs are clinically driven and tailored to meet each patient’s needs.

Research shows that a combination of medication and psychosocial support can successfully treat these disorders, and for some people struggling with addiction, MOUD can help sustain recovery.

Medication for opioid use disorder ("MOUD") is the use of medications, in combination with counseling and behavioral therapies, to provide a “patient-centric” approach to the treatment of OUD.

MOUD are approved by the FDA.

MOUD programs are clinically-driven and tailored to meet each patient’s needs.

Research shows that a combination of medication and psychosocial support can successfully treat OUD, and for some people struggling with addiction, MOUD can help sustain recovery.

MOUD is also used to prevent or reduce opioid overdose.

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A common misconception about MOUD is that some of the medicines used simply substitute one drug for another.

However, these medications may restore healthy brain function, which leads to improvements in behaviors associated with addiction.

However, these medications may

restore healthy brain function, which leads to improvements in behaviors associated with addiction.

Longer-term use of these medications is associated with improved outcomes.

Treatment methods in the EU differ from those in the U.S.

patients can obtain a 30-day prescription and self-administer treatment, such as SUBOXONE Film, prescribed by a treating physician, supervised dosing in the EU requires a daily visit to the clinic for many patients.

Methadone and generics

are also generally more broadly available as social funding puts pressure on prices, and treatment is more highly regulated.

However, the harm reduction mindset is now changing towards recovery and the EU has begun to recognize the need to implement treatment systems that allow patients to return to a more normal lifestyle.

Indivior’s MOUD product, SUBLOCADE, contains buprenorphine, a partial μ-opioid receptor agonist, delivered as a monthly subcutaneous injection.

It is designed to control the main drivers of OUD (withdrawal, craving, and drug liking) across the continuum of patients/treatment stages.

(Laffont CM, et al., Front Pharmacol , 2022).

SUBLOCADE provides an alternative to daily treatment, improves retention, and may help address the health, societal, and economic burden associated with OUD.

(Greenwald MK, et al., Harm Reduct J.

A single monthly dose of SUBLOCADE delivers sustained buprenorphine plasma concentrations at therapeutic levels (≥2 ng/mL) required to control OUD symptoms in most patients.

(Haight BR, et al., Lancet , 2019).

By delivering high sustained buprenorphine levels, SUBLOCADE may also minimize respiratory depression induced by synthetic opioids such as fentanyl.

(Olosfen E, et al., JCI insight 2022).

Patients on stable treatment with SUBLOCADE achieve greater treatment retention and report less illicit opioid use vs placebo.

(Boyett B, et al., J Addict Med.

Craft WH, et al., Addiction 2023).

Treatment access

Despite the prevalence of SUD, including opioid misuse, and the existence of effective treatments, including medication for opioid use disorder, most people who need treatment do not seek or receive it.

In 2022, an estimated 4% of U.S.

adults (9,367,000) needed OUD treatment.

Among these, 55% (5,167,000) received OUD treatment, and 25% (2,353,000) received medications for OUD.

Source - Treatment for Opioid Use Disorder:

Population Estimates—United States, 2022 Morbidity and Mortality Weekly Report.

People in urgent need of treatment are often unaware of their treatment options, have limited access to treatment and counseling, or simply do not seek it out because they are afraid of being stigmatized.

In addition, access is also limited by numerous legal restrictions for pharmacological treatment, inadequate training of clinicians, and the number of HCPs who are willing to treat this population.

During 2023, our INSUPPORT ® Community Reentry Program (“CRP”) reached a celebrated milestone of receiving over 100 program enrollments.

INSUPPORT was created to provide information aimed at helping eligible patients with the process of obtaining Indivior medicines and to enhance our existing patient transition of care offerings.

CRP was designed for patients released from the CJS who are experiencing a gap in insurance coverage.

Additionally, access may be limited by numerous legal restrictions for pharmacological treatment, inadequate training of clinicians, and the number of HCPs who are willing to treat this population.

In response, our INSUPPORT ® Community Reentry Program (“CRP”) provides information aimed at helping eligible patients with the process of obtaining Indivior medicines and to enhance our existing patient transition of care offerings.

CRP was designed for patients released from the criminal justice system experiencing a gap in insurance coverage.

Eligible patients may receive up to two months of SUBLOCADE ® (buprenorphine extended-release) subcutaneous injection at no cost while awaiting reinstatement of health insurance.

Focus on the Criminal Justice System

In the U.S., a substantial share of persons suffering from OUD repeatedly cycle through the criminal justice system.

Further, persons exiting the criminal justice system have been shown to be 40 times more likely to suffer from opioid overdose than persons in the general population.

While as recently as 2019 buprenorphine was rarely available to patients in criminal justice settings, such treatment is increasingly becoming available.

The shift has been spurred by research findings and pronouncements from industry and professional medical societies that evidence-based treatment for OUD in correctional settings saves lives, which in turn has shaped changes in law and policy.

Treatment for OUD in correctional settings has been shown to reduce overdose deaths by 75%, reduce recidivism by 32%, and reduce transmission of HIV and hepatitis.

Public policy is trending toward increasing treatment of SUD and serious mental illness in criminal justice settings.

Congress continues considering legislation authorizing Medicaid coverage of persons in correctional settings.

The Centers for Medicare & Medicaid Services (CMS) has published guidance to states on how they can apply to the agency for Medicaid funding to support treatment of patients with OUD and mental illness in the criminal justice system up to 90 days pre-release.

Department of Justice (DOJ) issued guidance in April 2022 underscoring the rights of persons with OUD to treatment under the Americans with Disabilities Act, including in correctional settings.

States have been increasingly enacting legislation and appropriations, and seeking federal waiver authority, to expand treatment availability in criminal justice settings.

Opioid Overdose Reversal

In addition to OUD treatments, we provide OPVEE (nalmefene) nasal spray for overdose reversal.

A large and growing addressable market for opioid overdose reversal agents exists in the U.S., such as first responders, including fire departments, emergency medical services, law enforcement, and other community groups.

We expect the primary customers for OPVEE to include state health departments, substance abuse centers, federal agencies, and eventually consumers through pharmacies fulfilling

physician-directed or standing order prescriptions.

The co-prescribing of opioid overdose reversal agents alongside prescription opioids has also driven growth of overdose reversal agents.

Indivior Products

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(in millions)

Opioid Use Disorder

Long-Acting Injectable

SUBUTEX Prolonged Release

extended-release Injectable

Buprenorphine Extended-release injectable suspension U.S., Australia, Canada, Finland, Israel, and Sweden

Buprenorphine Extended-release injectable suspension U.S., Australia,

Sublingual $346

SUBOXONE Film Buprenorphine and Naloxone Sublingual film that adheres under the tongue or on the inside of the cheek for direct absorption into the bloodstream U.S., Australia, Canada, Finland, Israel, Italy, Malaysia, and Sweden

SUBOXONE Tablet Buprenorphine and Naloxone Sublingual tablet that is placed under the tongue to dissolve

Belgium, Canada, Germany, and U.K.

SUBUTEX Tablet Buprenorphine Sublingual tablet that is placed under the tongue to dissolve Australia, France, Germany, Israel, Norway, Switzerland, and U.K.

Opioid Overdose Reversal $15

OPVEE nasal spray

Nalmefene Nasal spray U.S.

SUBOXONE Film Buprenorphine and naloxone

Sublingual film that adheres under the tongue or on the inside of the cheek for direct absorption into the bloodstream U.S., Australia,

SUBUTEX Tablet Buprenorphine Sublingual tablet that is placed under the tongue to dissolve Australia, France, and Germany

(1) See “ Item 7.

Manageme nt's Discussion & Analysis — Operating Results ” for data for each of the last three financial years.

Management's Discussion & Analysis—Operating Results ” for data for each of the last three financial years.

SUBLOCADE Long-acting injectable (buprenorphine) extended-release injection

As the first long-acting buprenorphine-based injectable approved by the FDA for the treatment of moderate to severe OUD, SUBLOCADE is a highly differentiated treatment.

Our RECOVER extension study, which was a 24-month observational study of individuals who participated in the Phase 3 SUBLOCADE study, assessed life changes in patients with OUD who received SUBLOCADE as part of a randomized clinical efficacy study.

It showed that SUBLOCADE may translate into (1) increased abstinence from illicit opioids compared to placebo;

(2) improved patient-reported quality-of-life outcomes (such as health status, employment and insurance status, and healthcare resource utilization);

and (3) improved recovery post-treatment.

Administration of monthly subcutaneous injections of SUBLOCADE also eliminates the risk of missing daily doses that might result in subtherapeutic plasma levels (see below), potentially leading to relapse to opioid-seeking and opioid-taking behaviors.

Finally, because SUBLOCADE may only be administered by a healthcare practitioner via a closed distribution system whereby the patient never has access to the drug, it is expected to reduce the potential for diversion or misuse.

The logic that underpins this technology lies in a deep understanding of the relationship between buprenorphine plasma levels, whole-brain mu-opioid receptor occupancy (MOR) in the brain, and the key clinical pharmacodynamic effects of withdrawal suppression and opioid blockade.

Clinical studies confirmed that the minimum threshold plasma concentration of buprenorphine needed to effectively block the subjective drug-liking effects of a full opioid agonist such as hydromorphone is 2 ng/mL, which translated into at least 70% MOR occupancy for the entire one-month period.

These unique pharmacokinetic and

pharmacodynamic properties of SUBLOCADE also translated into clinical efficacy and safety and better patient outcomes.

As the first long-acting buprenorphine-based injectable approved by the FDA for the treatment of moderate to severe OUD, SUBLOCADE is a highly differentiated treatment, having treated over 475,000 patients since approval.

The logic underpinning this technology lies in the relationship between buprenorphine plasma levels, whole-brain mu-opioid receptor occupancy (MOR) in the brain, and the key clinical pharmacodynamic effects of withdrawal suppression and opioid blockade.

Clinical studies confirmed the minimum threshold plasma concentration of buprenorphine needed to effectively block the subjective drug-liking effects of a full opioid agonist such as hydromorphone is 2 ng/mL, which translated into at least 70% MOR occupancy for the entire one-month period.

SUBLOCADE 100mg is designed to deliver >2ng/mL and the 300mg dose delivers >5ng/mL at steady state.

These unique pharmacokinetic and pharmacodynamic properties of SUBLOCADE also translated into clinical efficacy and safety and better patient outcomes.

The expected benefits of these levels of receptor occupancy/opioid blockade are that:

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• Patients should receive no gratification from abuse of opioids;

• Levels of adherence and compliance with treatment should be significantly improved because it is administered once monthly and late administration of up to 14 days is not expected to affect clinical efficacy;

• It is designed to protect patients right from the start of treatment, through every day of the month, including moments of vulnerability;

• Adherence and compliance with treatment should be significantly improved because it is administered once monthly and late administration of up to 14 days is not expected to affect clinical efficacy;

• Patients are protected right from the start of treatment, through every day of the month, including moments of vulnerability;

• For physicians, there should be positive clinical and patient outcomes using this technology;

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• For payors, the benefit should come in reduced costs from higher compliance, better clinical outcomes and reduced abuse and diversion.

Our RECOVER extension study, a 24-month observational study of individuals who participated in the Phase 3 SUBLOCADE study, assessed life changes in patients with OUD who received SUBLOCADE as part of a randomized clinical efficacy study.

It showed that SUBLOCADE may translate into (1) increased abstinence from illicit opioids compared to placebo;

(2) improved patient-reported quality-of-life outcomes (such as health status, employment and insurance status, and healthcare resource utilization);

and (3) improved recovery post-treatment.

On February 24, 2025, we announced that the U.S.

Food and Drug Administration (FDA) approved label changes for SUBLOCADE including a rapid initiation protocol and alternative injection sites.

Food and Drug Administration (FDA) approved label changes for SUBLOCADE including a rapid initiation protocol and alternative injection sites, making it the only monthly LAI that can be initiated starting on day 1.

Healthcare providers can now initiate treatment with SUBLOCADE after a single dose of transmucosal buprenorphine and a one-hour observation period to confirm tolerability.

Also, SUBLOCADE can be administered with a second dose as early as one week after initiation, which helps maximize the time plasma concentrations are >2 ng/mL during the initiation period.

SUBLOCADE can now also be administered subcutaneously in the abdomen, thigh, buttock, or back of the

upper arm, offering patients and healthcare providers increased flexibility in treatment administration starting at day 1.

These FDA label changes can provide important benefits for patients and healthcare providers.

Rapid initiation may lessen some of the practical obstacles to treatment induction, which may increase the likelihood that patients and providers will start therapy quickly, thereby shortening the time to achieve SUBLOCADE's therapeutic levels providing continuous buprenorphine concentrations above 2ng/mL.

Additionally, the ability to select a different injection site may provide patients more flexibility so that they may be inclined to continue their treatment.

More options for healthcare providers to administer SUBLOCADE will streamline the course of treatment and improve integration into different healthcare environments.

We currently distribute SUBLOCADE (under the name SUBUTEX Prolonged Release in Europe) primarily in the U.S., Australia, Canada, Finland, Israel, and Sweden.

Additional important data introduced in June 2025 include a post-hoc analysis demonstrating that buprenorphine exposure with 300 mg SUBLOCADE may improve treatment outcomes among OUD patients with heavy fentanyl use.

These data are particularly important given the dynamic risks OUD patients face in the era of synthetic opioids.

The findings align to the American Society of Addiction Medicine (ASAM) Clinical Considerations which indicates high plasma concentrations at steady state with continuous exposure offered by extended release buprenorphine may help stabilize individuals using high potency synthetic opioids.

In November 2025, Indivior presented new Real-World Evidence demonstrating economic benefits of adherence to monthly injectable buprenorphine, with lower relapse rates and reduced healthcare utilization for adherent patients insured by both Medicaid and Commercial plans.

SUBLOCADE continues to have broad payor access in the U.S.

with over 88% of insured lives covered and over 95% of patients enrolled in the SUBLOCADE co-pay program paying $0 out of pocket.

We currently distribute SUBLOCADE primarily in the U.S., Australia, and Canada.

SUBOXONE Film (buprenorphine and naloxone) sublingual film

SUBOXONE Film was initially launched in the U.S.

in 2010 and is currently approved in the U.S.

and sold in more than 30 other countries.

We currently distribute SUBOXONE Film primarily in the U.S., Australia, and Canada.

It is one of only four products currently approved by the FDA for the treatment of OUD in both the induction and maintenance phases of treatment (although several are approved for “treatment of opioid dependence”).

SUBOXONE Film was developed as an alternative to the sublingual tablet.

SUBOXONE Film was developed through an exclusive agreement with Aquestive (formerly known as Monosol), utilizing its proprietary technology, to deliver SUBOXONE Film in a fast-dissolving sublingual film.

SUBOXONE Film was developed as an alternative to the sublingual tablet through an exclusive agreement with Aquestive (formerly known as Monosol), utilizing its proprietary technology to deliver buprenorphine in a fast-dissolving sublingual film.

SUBOXONE Film containing 2 mg buprenorphine and 0.5 mg naloxone, and 8 mg buprenorphine and 2 mg naloxone, was first approved for the maintenance treatment of OUD in the U.S.

in August 2010.

Additional dosage strengths of SUBOXONE Film containing 4 mg buprenorphine and 1 mg naloxone, and 12 mg buprenorphine and 3mg naloxone, were subsequently approved in the U.S.

in August 2012 and in

Australia in May 2014.

in 2012 and in Australia in 2014.

SUBOXONE Film was also approved in the U.S.

in April 2014 for use in the induction phase of buprenorphine-based treatment of OUD.

In addition, in September 2015 the FDA approved the buccal (against the cheek) route of administration for SUBOXONE Sublingual Film.

in 2014 for use in the induction phase of buprenorphine-based treatment of OUD.

In addition, in 2015 the FDA approved the buccal (against the cheek) route of administration for SUBOXONE Sublingual Film.

The Company’s U.S.

sales force ceased promoting SUBOXONE Film as required by the Resolution Agreement with the DOJ and ceased all detailing of the product in 2020, though it remains available for sale.

F or more information, see Item 8 .

Financial Statements—Audited Consolidated Financial Statements - Note 16.

Commitments and Contingencies .

We currently distribute SUBOXONE Film primarily in the U.S., Australia, Canada, Finland, Israel, Italy, Malaysia, and Sweden .

sales force ceased promoting SUBOXONE Film as part of the Resolution Agreement with the DOJ and ceased all detailing of the product in 2020, though it remains available for sale.

SUBUTEX Tablet (buprenorphine) sublingual tablet

SUBUTEX Tablet containing 0.4 mg, 2 mg, and 8 mg buprenorphine was first approved for the treatment of opioid dependence in France in 1995 and was launched in the French market in 1996.

In 2003, 2 mg and 8 mg tablets were subsequently approved in the U.S.

and launched but were discontinued from sale in the U.S.

market in 2011.

We distribute SUBUTEX tablets primarily in Australia, France, and Germany.

SUBOXONE Tablet (buprenorphine and naloxone) sublingual tablet

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SUBOXONE Tablet containing 2 mg buprenorphine and 0.5 mg naloxone, and 8 mg buprenorphine and 2 mg naloxone, was approved in the U.S.

by the FDA in October 2002 as an orphan drug for maintenance treatment of opioid dependence.

SUBOXONE Tablet is distributed primarily in Belgium, Canada, Germany, and U.K.

by the FDA in 2002 as an orphan drug for maintenance treatment of opioid dependence.

We distribute SUBOXONE Tablets on a transition basis in a limited number of countries.

(We discontinued distribution of SUBOXONE and SUBUTEX Tablets in the U.S.

market in March 2013.)

SUBUTEX Tablet (buprenorphine) sublingual tablet

SUBUTEX Tablet containing 0.4 mg, 2 mg, and 8 mg buprenorphine was first approved for the treatment of opioid dependence in France in July 1995 and was launched in the French market in February 1996.

In April 2003, 2 mg and 8 mg tablets were subsequently approved in the U.S.

and launched but were discontinued from sale in the U.S.

market in September 2011.

We primarily distribute SUBUTEX tablets primarily in Australia, France, Germany, Israel, Norway, Switzerland, and U.K.

OPVEE (nalmefene) nasal spray

On May 22, 2023, the FDA approved OPVEE (nalmefene) nasal spray for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression .

OPVEE (nalmefene) nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present.

OPVEE (nalmefene) nasal spray is not a substitute for emergency medical care.

OPVEE contains 2.7 mg nalmefene.

Nalmefene works quickly by blocking the brain opioid receptors.

In a clinical model of opioid-induced respiratory depression in opioid-experienced, non-dependent subjects, OPVEE had an onset of action of 2.5 to 5 minutes and fully reversed respiratory depression as early as 5 minutes after OPVEE administration.

Other clinical data include a terminal plasma half-life of approximately 11 hours.

While the duration of action of nalmefene is as long as most opioids, a recurrence of respiratory depression is possible.

We currently only distribute OPVEE in the U.S.

market in 2013.)

Discontinuation of Marketing and Promotion of PERSERIS

In July 2024, the Company discontinued the marketing and promotion of PERSERIS due to impending market changes that would make the product no longer financially viable.

The Company has continued to supply PERSERIS to avoid disruption to patient care but no longer deploys a dedicated sales force.

The FDA approved PERSERIS as the first once-monthly subcutaneous extended-release injectable suspension of risperidone indicated for the treatment of schizophrenia in adults in 2018.

We launched commercial sales of PERSERIS in the U.S.

However, in July 2024, the Company discontinued the marketing and promotion of PERSERIS due to expected market changes that would make the product no longer financially viable.

The Company committed to continue to make available PERSERIS to avoid disruption to patient care but no longer deploys a dedicated sales force and has ceased manufacturing PERSERIS.

Discontinuation of Marketing and Promotion of OPVEE (nalmefene) nasal spray for Overdose Reversal

We began marketing OPVEE in the U.S.

in October 2023.

However, during the third quarter of 2025, the Company made a strategic decision to discontinue the sales and marketing support for OPVEE.

The Company will continue to distribute OPVEE upon request and meet all required contractual and regulatory obligations.

We operate in a highly competitive industry.

While we seek patent and trademark protection where appropriate, several of our branded products face competition from generic products in key markets as well as competition from alternative products and treatments.

For example, SUBLOCADE is patent protected in the U.S., Australia, Canada, the U.K., Ireland, France, Germany, Italy, Spain, Denmark, Finland, Norway, the Netherlands, Switzerland, Sweden, Israel, Japan, Mexico and New Zealand.

For example, SUBLOCADE is patent protected in the U.S., Australia, and Canada.

However, Camurus, in partnership with its U.S.

marketing partner Braeburn, obtained FDA approval of its LAI buprenorphine product BRIXADI ® in the U.S.

Outside the U.S., this product (marketed as BUVIDAL ® ) enjoys first mover advantage in all countries except Canada.

It is well established in the Nordics (Norway, Sweden, Finland, and Denmark) and Australia, and available in other parts of Europe.

Our SUBOXONE Film product already faces five generic competitors in the U.S.

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

Outside the U.S., this product (marketed as BUVIDAL ® ) enjoys first mover advantage in all countries except Canada, and is well established in Australia.

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

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

We no longer promote SUBOXONE Film in the U.S.

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In Europe and Canada, SUBOXONE Film enjoys patent protection until 2030.

In Europe, generic versions of the SUBUTEX Tablets have been available since 2010 and SUBOXONE Tablets since 2018.

In addition, we face competition from branded oral buprenorphine-based tablets and historically well-established methadone oral formulations.

In France and Germany, generic versions of the SUBUTEX Tablets have been available since 2010 and SUBOXONE Tablets since 2018.

Additionally, we face competition from branded oral buprenorphine-based tablets and historically well-established methadone oral formulations.

In Canada, our SUBOXONE Tablets product faces two generic competitors.

We have seen our market share of SUBOXONE Tablets eroding overtime.

OPVEE is the first nalmefene nasal spray approved by the FDA for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression.

OPVEE (nalmefene) nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present.

OPVEE (nalmefene) nasal spray is not a substitute for emergency medical care.

It competes with branded and generic naloxone nasal sprays including Narcan ® (naloxone HCI) Nasal Spray 4 mg (which is not available without a prescription), 4 mg naloxone generic equivalents, and KLOXXADO ® (naloxone HCI) Nasal Spray 8 mg.

It also competes with naloxone or nalmefene administered by syringe and over-the-counter (“OTC”) intranasal naloxone HCl.

The introduction of generic or branded products that compete with the Company’s products or heightened competition amongst existing participants could impact both the market share of the Company’s products and pricing and, therefore, adversely impact its results of operations.

The introduction of generic products typically leads to a loss of sales of a branded product and/or a decrease in the price at which branded products can be sold.

In addition, legislation enacted in the U.S.

Our category share of SUBOXONE Tablets has eroded over time.

The introduction of generic or branded products competing with the Company’s products or heightened competition amongst existing participants could impact both the category share of the Company’s products and pricing and, therefore, adversely impact its results of operations.

The introduction of generic products typically leads to a loss of sales of a branded product and/or a decrease in the net price at which branded

products can be sold.

Additionally, legislation enacted in the U.S.

and several EU countries allows for, and in a few instances in the absence of specific instructions from the prescribing physician, mandates the dispensing of generic products rather than branded products where a generic version is available.

Research and Development

We invest in research and development to create innovative medications and services that address the needs of patients with the complex chronic condition of SUD.

These efforts include the development of new medications that are designed to minimize diversion and misuse, increase compliance with treatment, support public health, improve patient outcomes and expand access to treatment for areas of SUD where no pharmacotherapy is currently available.

Chronic addictive behaviors are characterized by compulsive drug and alcohol use, loss of control over drug-seeking and drug-taking, and an intense drive to take the drug at the expense of other behaviors, with little regard for subsequent consequences.

From a psychiatric perspective, SUD has aspects of both impulse control disorders and compulsive disorders.

In addictive and compulsive disorders, which have prominent motivational drivers, dysfunction in the brain’s cortical regions significantly affects cognitive

regulatory processes such that the individual fails to inhibit self-defeating urges or desires appropriately.

This failure to resist repetitive, maladaptive behaviors is a key clinical feature of SUD, and aspects of decision-making are compromised either directly (i.e., a dysfunctional inhibitory system) or indirectly (i.e., a dysfunctional reward system).

Indivior has a long history of supporting the SUD treatment community:

Research and Development (R&D)

Indivior’s R&D strategy is designed to deliver transformative therapies addressing unmet needs.

By combining scientific rigor, patient-centric innovation, collaboration, and decades of leadership in addiction medicine, we strive to redefine standards of care for opioid use disorder (OUD) and related disorders.

OUD is a chronic, relapsing condition characterized by compulsive drug use, impaired control over drug-seeking behavior, and persistent cravings despite harmful consequences.

From a psychiatric perspective, OUD shares features of both impulse-control and compulsive disorders.

Dysfunction in cortical brain regions disrupts cognitive regulation, compromising decision-making and inhibitory control.

This neurobiological complexity underscores the need for innovative pharmacotherapies that address both reward and regulatory systems.

Indivior has a long history of supporting the OUD treatment community:

it discovered buprenorphine in 1966 and has been involved in manufacturing and supplying buprenorphine to patients as a treatment for OUD.

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Indivior launched the first buprenorphine-based medication for the treatment of OUD in France in 1996.

The Company’s medications are now available in more than 30 countries and include buprenorphine sublingual tablets (SUBUTEX), buprenorphine and naloxone sublingual tablets (SUBOXONE), buprenorphine and naloxone sublingual film (SUBOXONE Film), and the first FDA-approved once-monthly injectable buprenorphine formulation (SUBLOCADE).

The Company’s medications are now available in the U.S., Canada, Australia, France, and Germany and include buprenorphine sublingual tablets (SUBUTEX), buprenorphine and naloxone sublingual film (SUBOXONE Film), and the first FDA-approved once-monthly injectable buprenorphine formulation (SUBLOCADE).

All along, Indivior has invested in education programs on evidence-based treatment models that have helped change modern addiction medicine and transform the perception of SUD from a global human crisis to a chronic disease that should be recognized and treated.

Our research and development personnel also have experience in opioid overdose reversal as a result of our acquisition of Opiant Pharmaceuticals, Inc.

in March 2023.

Members of our Research and Development staff contributed to the regulatory approval of OPVEE (nalmefene) nasal spray for the emergency treatment of known or suspected overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older.

On September 27, 2023, the U.S.

Biomedical Advanced Research and Development Authority (BARDA) awarded us a $32 million contract to support FDA-required post-marketing requirement studies, 3-year stability studies to support shelf-life extension, real world evidence studies, and procurement of packaged OPVEE held as vendor-managed inventory as a medical countermeasure in the event of a synthetic opioid community or mass casualty event.

Our research and development team is led by our Chief Scientific Officer, Dr.

Christian Heidbreder, a leading authority in the development of SUD treatments, and consists of approximately 100 persons distributed across the following sub-functions:

• Global Chemistry, Manufacturing, and Controls ("CMC") includes capabilities spanning formulation development, analytical development, chemical development, process development, and technology transfer.

Indivior CMC facilities based in Hull (United Kingdom) and Fort Collins (Colorado, USA) are equipped with cutting-edge technologies including pilot plant storage, formulation laboratories, analytical laboratories, chemistry laboratories, stability chambers, office spaces, and support spaces.

These facilities are also built to environmental and energy-saving standards, including the installation of a solar panel farm to increase use of renewable energy.

• Global Medicines Development encompasses all required functions to support clinical and nonclinical development, from early to late stage clinical development including pivotal Phase 3 trials and post-marketing commitment and requirement studies:

(1) medical, scientific writing, publications and communication;

(2) clinical development and operations;

(3) data and statistical sciences;

(4) clinical pharmacology and nonclinical sciences;

(5) epidemiology;

(6) clinical, medical and safety compliance, and (7) translational medicine.

• Global Regulatory Affairs focuses on (1) regulatory strategy;

(2) regulatory CMC and compliance;

(3) regulatory operations;

(4) global labeling and advertisement/promotion;

and (5) local regulatory affairs in North America (US and Canada), Europe and Middle-East (EEA (31 countries), Switzerland, Israel, South Africa, Botswana, Lebanon, Kuwait, Qatar, Bosnia, Turkey, Algeria), and Australasia (Australia, New Zealand, Indonesia, Malaysia, Singapore, Vietnam, Hong Kong & Taiwan).

Our research and development function endeavors to conduct all clinical trials (Phase I through Phase IV) in partnership with Clinical Research Organizations.

During Phase II and Phase III clinical trials,

we also engage contractors with the relevant capabilities because the formulation of the medication must be finalized and the scalability of production proven.

During the various phases of clinical trials, the number of participants in, and consequently the expenses related to, the project increase significantly.

Please refer to “ Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations” for further details of research and development expenses during the financial periods included in this annual report.

Our research and development activities are focused on building on our leadership position in the treatment of opioid use disorder ("OUD").

Our R&D team is led by our Chief Scientific Officer, Dr.

Christian Heidbreder, and consists of approximately 72 employees across three core sub-functions:

• Chemistry, Manufacturing, and Controls ("CMC") includes capabilities spanning formulation development, analytical and chemical development, process optimization, and technology transfer.

• Medicines Development (“MD”) encompasses all required functions to support clinical and nonclinical development, from early to late stage clinical development including pivotal Phase 3 trials and post-marketing commitment and requirement studies.

• Regulatory Affairs (“RA”) focuses on regulatory strategy, regulatory operations, labeling, and advertisement/promotion compliance.

Our R&D function endeavors to conduct all clinical trials (Phase I through Phase IV) in partnership with Clinical Research Organizations.

During Phase II and Phase III clinical trials, we may also engage contractors with the relevant capabilities because the formulation of the medication must be finalized and the scalability of production proven.

During the various phases of clinical trials, the number of participants in, and consequently the project expenses, increase significantly.

See “ Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations ” for further details of R&D expenses during the financial periods included in this annual report.

Our R&D activities are focused on building on our leadership position in the treatment of OUD.

H owever, our pipeline reflects only potential products, and any product requires completion of clinical trials to demonstrate safety and efficacy, and approval by the FDA.

See “ Item 1A—Risk Factors — 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 .”

INDV-2000 Selective Orexin-1 Receptor Antagonist

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

On June 10, 2024 we announced the dosing of the first subject with INDV-2000 in a Phase 2 double-blind, placebo controlled, randomized, dose-ranging study to assess the safety and efficacy of INDV-2000 over 3 months in treatment-seeking individuals with OUD.

The purpose of this proof-of-concept study is to measure safety and efficacy and to determine the dose-response relationship for INDV-2000 in participants with moderate to severe OUD who are treatment-naïve, have recently initiated or completed short-term medically supervised opioid withdrawal with transmucosal (TM) buprenorphine, and are interested in transitioning to a non-opioid treatment.

We expect this study to be completed by the end of 2025.

patents for INDV-2000 expire in 2037.

See “ Item 1A—Risk Factors — 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.”

INDV-6001 Sustained Release LAI Prodrug of Buprenorphine

INDV-6001 is potentially the first three-month LAI buprenorphine for the treatment of OUD.

In 2023, the Company secured global rights from Alar Pharmaceuticals to develop, manufacture, and commercialize INDV-6001 and a portfolio of buprenorphine-based LAI.

The Company made an upfront payment of $10 million, which is in addition to the $5 million option payment made by the Company in the first quarter of 2023.

INDV-6001 is being developed as the first three-month LAI buprenorphine for the treatment of OUD.

In 2023, the Company secured global rights (except for China, Taiwan, Hong Kong, and Macau) from Alar Pharmaceuticals to develop, manufacture, and commercialize INDV-6001 and a portfolio of buprenorphine-based LAIs.

The Company made an upfront payment of $10 million and a $5 million option payment in the first quarter of 2023.

The licensor would be entitled to potential milestone payments upon the achievement of various developmental, regulatory, and commercial goals, and entitled to royalties in the low double digit to mid-teens as a percentage of net revenue.

In September 2024, we initiated a multiple dose clinical Phase 2 Pharmacokinetic study (NCT06576843 ).

The last patient, last visit for this study occurred in the fourth quarter of 2025, and we expect to be able to announce r esults in the second quarter of 2026.

The current U.S.

patents for INDV-6001 expire in 2039.

In September 2024, we commenced a multiple dose clinical Phase 2 Pharmacokinetic study which we expect to complete by the end of 2025.

Decision to Not Exercise Option For AEF0117 Aelis

On September 4, 2024, we noted Aelis Farma's announcement of the results from its clinical Phase 2B trial with AEF0117, a synthetic CB1 specific signaling inhibitor designed to treat cannabis-related disorders.

This clinical Phase 2B study was part of the strategic collaboration between Aelis Farma and Indivior, which included an exclusive option for Indivior to license the global rights to AEF0117, and was designed to evaluate the efficacy and safety in treatment-seeking participants with moderate to severe Cannabis Use Disorder.

Given the lack of separation from placebo on primary and secondary endpoints, and before seeing further additional favorable clinical data, we announced that we do not currently expect to exercise our option.

INDV-2000 Selective Orexin-1 Receptor Antagonist

INDV-2000 (Selective Orexin-1 Receptor Antagonist), is a non-opioid treatment for moderate to severe OUD.

In June 2024, we announced dosing of the first subject with INDV-2000 in a Phase 2 double-blind, placebo controlled, randomized, dose-ranging study (NCT06384157) to assess the safety and efficacy of INDV-2000 over 3 months in treatment-seeking individuals with OUD.

The purpose of this proof-of-concept study is to assess the safety and efficacy of INDV-2000 and determine its dose-response relationship in participants with moderate to severe OUD who are treatment-naïve, have recently initiated or completed short-term medically supervised opioid withdrawal with transmucosal (TM) buprenorphine, and are interested in transitioning to a non-opioid treatment.

The last patient, last visit for this study was achieved on November 3, 2025, and we expect to be able to announce results in the second quarter of 2026.

The current U.S.

patents for INDV-2000 expire in 2037.

Manufacturing and Supply

Raw Materials

Active Pharmaceutical Ingredients (“API”)

Active Pharmaceutical Ingredients

The Company sources a large portion of its active pharmaceutical ingredients ("API") from its own manufacturing facilities.

The API used in our buprenorphine products are manufactured at our Fine Chemical Plant ("FCP") located in Hull, United Kingdom.

FCP manufactures the buprenorphine HCl API used in the manufacture of SUBOXONE Film, SUBUTEX Tablet, and SUBOXONE Tablet and the buprenorphine base API ("buprenorphine") used in the formulation of SUBLOCADE long-acting injection.

Historically, a third party has manufactured the buprenorphine base and the FCP will be capable of manufacturing the base beginning in 2025.

FCP has the capacity to produce all of our current buprenorphine related requirements with approximately 25% demonstrated capacity remaining.

We believe there are adequate supplies of the raw materials used to manufacture buprenorphine, and the ingredient is readily available from other suppliers (although it would require significant time to qualify and obtain regulatory approval to change suppliers).

We procure the naloxone HCl active pharmaceutical ingredient mainly from a single supplier for both SUBOXONE Tablet and SUBOXONE Film, although this is readily available from other suppliers (it would require significant time to qualify and obtain regulatory approval to change suppliers).

The primary API used in our buprenorphine products are manufactured at our Fine Chemical Plant ("FCP") located in Hull, United Kingdom.

The FCP manufactures the buprenorphine HCl API used in the manufacture of SUBOXONE Film, SUBUTEX Tablet, and SUBOXONE Tablet, and the buprenorphine base API used in the formulation of SUBLOCADE long-acting injection.

The FCP has the capacity to produce all of our current buprenorphine-related requirements.

We believe adequate supplies of the raw materials used to manufacture buprenorphine are available, and the ingredients are readily available from other suppliers (although it would require significant time to qualify and obtain regulatory approval to change suppliers).

We procure the naloxone HCl active pharmaceutical ingredient mainly from a single supplier for both SUBOXONE Tablet and SUBOXONE Film.

It is readily available from other suppliers (however it would require significant time to qualify and obtain regulatory approval to change suppliers).

Buprenorphine and products containing buprenorphine are classified as Schedule III controlled narcotics in the U.S.

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While this process has not impacted product supply to our patients in the past, it presents a manufacturing and product supply risk that must be monitored and managed closely.

We procure the active ingredient (nalmefene HCl) and the absorption enhancer (dodecyl maltoside) for OPVEE from single suppliers.

SUBLOCADE (buprenorphine extended-release) injection for subcutaneous use is manufactured under an agreement with Curia.

We provide the buprenorphine base, polymer and syringe assembly used in the manufacture of SUBLOCADE.

Curia has two manufacturing facilities located in Burlington, Massachusetts and Albuquerque, New Mexico.

Manufacture of all SUBLOCADE output for the U.S.

and Canadian markets is approved at both facilities, while output intended for the Most of World currently is approved only at the Burlington facility.

We plan to obtain approval to manufacture SUBLOCADE for the Most of World at the Albuquerque facility.

In addition, we are improving our Raleigh Manufacturing Facility to potentially manufacture SUBLOCADE to better secure its long-term supply.

In addition, we are improving our Raleigh Manufacturing Facility to manufacture SUBLOCADE to better secure its long-term supply.

However, it will take time and investment in equipment and validation testing before we can make regulatory submissions to gain approval for commercial manufacture of SUBLOCADE at this site.

See “ Item 1A.—Risk Factors —We rely on third parties to manufacture commercial supplies of most of our products, whose facilities and processes must meet stringent regulatory requirements.”

We rely on third parties to manufacture and package the products, and to perform quality assurance and quality testing.

SUBOXONE Film

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Manufacturing and primary packaging of all SUBOXONE Film output for most markets is approved at both facilities.

Secondary packaging of SUBOXONE Film is performed at Sharp Packaging Services.

SUBOXONE and SUBUTEX Tablets

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RB manufactures and performs the packaging of all SUBOXONE and SUBUTEX tablets globally at its facility in Hull, United Kingdom.

OPVEE (nalmefene) nasal spray

We have contracted for the commercial supply of OPVEE with Kindeva Drug Delivery (formerly Summit BioSciences).

SpecGx LLC provides the nalmefene HCl and Aegis Therapeutics, LLC provides the dodecyl maltoside (an absorption enhancer) used in the manufacture of OPVEE.

Our exclusive license agreement with Aegis Therapeutics obligates us to pay a tiered low to mid-single digit royalty on net sales, and a potential time sales milestone of $ 2 million for this nalmefene -dodecyl maltoside combination product.

PCI Pharma Services performs tertiary packaging of the commercial product.

Additional Manufacturing and Distributions Processes

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Sales, Marketing and Distribution

Our sales, marketing, and distribution processes for our products begin with a focus on the patient.

Our products are intended for patients who suffer from OUD or opioid overdose, each a highly stigmatized disease or disease state.

These patients are found not just in private physician offices, but also in emergency rooms, hospitals, addiction or rehabilitation centers, OHSs and, frequently, as part of their journey with addiction, as incarcerated individuals in the criminal justice system.

Our sales, marketing, and distribution processes begin with a focus on the patient.

Our products are intended for patients who suffer from OUD, a highly stigmatized disease state.

These patients are found not just in private physician offices, but also in emergency rooms, hospitals, addiction or rehabilitation centers, organized health systems and, frequently, as part of their journey with addiction, as incarcerated individuals in the criminal justice system.

Accordingly, w e focus our sales and marketing efforts not just on physicians in private practice but also to healthcare providers situated in these diverse treatment environments.

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We derive approximately 85% of our net revenues, and an even larger portion of our profitability, from the U.S.

Unlike many markets in the Most of World, the U.S.

Unlike many markets in the Rest of World, the U.S.

market is not a single payor market.

Instead, our activities are directed at a patchwork of federal and state agencies, organized health systems, criminal justice systems, and healthcare providers who provide treatment and assistance for patients suffering from OUD.

Instead, our activities are directed at federal and state agencies, organized health systems, criminal justice systems, and healthcare providers who provide treatment and assistance for patients suffering from OUD.

Payors and Reimbursement

We have dedicated professionals responsible for obtaining access and eliminating barriers to care at the national, regional, and state payor level, including every state Medicaid program.

We have coverage from approximately 90% of payors for our OUD products, including almost all commercial insurance payors, and the Veterans’ Administration, the Department of Defense, and the Bureau of Indian Affairs.

A significant portion of our customers are reimbursed through the Medicaid plans of states and the District of Columbia, primarily because most individuals suffering from OUD are not employed or do not have employer-based health coverage.

We have begun offering OPVEE to various government entities and community agencies.

These organizations typically receive grant funding related to the opioid epidemic which can be used for overdose reversal medications.

We have coverage from approximately 90% of payors for our OUD products, including almost all commercial insurance payors, the Veterans’ Administration, the Department of Defense, and the Bureau of Indian Affairs.

Also, a significant portion of our customers are reimbursed through the Medicaid plans of states and the District of

Columbia, primarily because most individuals suffering from OUD are not employed or do not have employer-based health coverage.

Organized Health Systems ("OHS")

Many patients who use our products are found at OHSs, such as health systems including hospitals and addiction treatment centers.

OHS are an important channel for our products because they have the resources and administration to appropriately handle controlled substances that are prescribed, delivered, and stored, and are equipped to administer the requirements applicable to our products, including REMS.

Many patients who use our products are found at OHSs, such as large health systems including hospitals and addiction treatment centers.

OHSs are an important channel for our products because they have the resources and administration to handle controlled substances that are prescribed, delivered, and stored, and are equipped to administer the requirements applicable to our products, including a risk evaluation and mitigation strategy ("REMS").

Our account teams call on key decision makers at OHSs to expand access to our products.

Our goal is to ensure access to our products by establishing treatment protocols (both medical and logistical), removing barriers to access, gaining formulary access where needed, and ensuring that protocols are in place to ensure compliance with applicable DEA, state, and local requirements regarding the storage of controlled substances.

As part of this process, the sales team focuses on effectively communicating the scientific rationale and the benefits of our products to HCPs, appropriately balanced with safety information, and the account teams and medical team focus on educating key decision makers about potentially better adherence, increased continuity of care, and overall cost and resource optimization in the total treatment plan.

As part of this process, the sales team focuses on effectively communicating the scientific rationale and the benefits of our products to HCPs, appropriately balanced with safety information.

The account and medical team focus on educating key decision makers about adherence, continuity of care, and overall cost and resource optimization in the total treatment plan.

Criminal Justice Systems ("CJS")

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A specialty treatment court is a court with expertise in substance abuse disorders which may offer alternative and deferred prosecution arrangements for appropriate persons.

For prisons, our dedicated teams attempt to increase access to our products, overcome logistical barriers to care, and promote particular products, but do not call on HCPs behind the walls of the prisons.

For specialty treatment courts, our Criminal Justice Access Directors, including approximately 46 trained and experienced professionals, educate judges, prosecutors, social workers, and patients about the benefits of our products.

The patient is ultimately referred to an HCP, either in a private office or federally qualified health center, where the decision to use medication for OUD, such as SUBLOCADE, is the patient’s decision with the assistance of his or her HCP.

For prisons, our dedicated teams attempt to increase access to our products, overcome logistical barriers to care, and promote particular products.

For specialty treatment courts, our Criminal Justice Access Directors, including trained and experienced professionals, educate judges, prosecutors, social workers, and patients about the benefits of our products.

The patient is ultimately referred to an HCP, either in a private office or qualified health center, where the decision to use medication for OUD, such as SUBLOCADE, is the patient’s decision with the assistance of his or her HCP.

At these referral sites and locations, our sales personnel coordinate with the HCPs and their staff to ensure understanding of the scientific rationale and the benefits of our products, appropriately balanced with safety information.

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Our commercial activities in the U.S.

are currently focused on SUBLOCADE long-acting injectable and OPVEE nasal nalmefene spray.

are currently focused on SUBLOCADE long-acting injectable.

Our sales force does not promote SUBOXONE Film in the U.S.

Our sales organization in the U.S.

comprises approximately 255 trained and experienced pharmaceutical professionals, which we call Clinical Specialists, who are managed by Area Sales Directors.

is comprised of experienced pharmaceutical professionals, which we call Clinical Specialists, who are managed by Area Sales Directors.

Clinical Specialists act as a vital link between the various stakeholders within the addiction community, including key opinion leaders, counselors, treatment advocates, pharmacists, nurses and healthcare providers in specialized treatment centers.

We believe that our clear focus on patient needs helps deepen customer relationships which then allows the team the time to engage in clinical and logistical discussions that dramatically improve patient access to treatment with SUBLOCADE.

We believe our clear focus on patient needs helps deepen customer relationships which then allows the team the time to engage in clinical and logistical discussions that dramatically improve patient access to treatment with SUBLOCADE.

Our Clinical Specialists are supported by dedicated and experienced professionals in our managed care group who create access to treatment for patients by partnering with U.S.

commercial payors and federal, state, and local governmental payo rs.

Our commercialization efforts for OPVEE are not targeted at patients initially.

Instead, we expect the primary customers for OPVEE will be:

• Single state authorities / grant administrators;

• Naloxone Coordinators;

• State/County/City Departments of Health;

• Veterans Affairs;

• Community based organizations groups;

• Substance abuse centers and opioid treatment programs;

• Law Enforcement;

• Department of Corrections;

• Fire/Emergency services;

• Targeted Healthcare Providers prescribing overdose reversal agents;

prescriptions would be filled at retail pharmacy and picked up by the patient.

Our commercialization strategy for OPVEE includes ensuring access to OPVEE via inclusion in state standing orders, enabling public funding, establishing relevant state emergency medical protocols, and securing adjustments to state Good Samaritan laws, through the work of our government affairs and medical teams.

In September 2023 we were awarded a contract by BARDA for the procurement of finished, packaged OPVEE held as vendor-managed inventory as a medical countermeasure in the event of a synthetic opioid community or mass casualty event.

The role of BARDA is to supplement state and local supplies during public health emergencies.

The contract also has options for purchases and delivery of OPVEE over 10 years at guaranteed pricing through 2033.

We delivered two orders to BARDA in 2024 for 200,000 doses.

Ultimately, or goal is to establish OPVEE as a differentiated brand by developing real world evidence, driving awareness by providing education to key stakeholders, and establishing OPVEE as the standard of care with the rise of synthetic opioids like fentanyl.

Advocacy, Education, and Patient Support

We collaborate with patient organizations, stakeholders and policymakers to achieve our vision that the millions of people across the globe suffering from SUDs will have access to evidence-based treatment to change lives.

Our advocacy agenda focuses on expanding access to treatment, advancing treatment equity, and increasing focus on patients in correctional settings.

Our educational and engagement efforts have focused on expanding the availability of treatment options beyond the clinical setting in the U.S.

in order to give patients the flexibility to receive appropriate treatment in the privacy of a physician’s office.

We also advocate for access to evidence-based treatment in correctional settings to ensure that resources are focused where challenges are greatest.

Equity in treatment is a barrier to care for patients.

For instance, patients in correctional settings sit outside the insurance system and are ineligible by federal law for Medicaid benefits.

We work to advance initiatives to increase patient access to medical care while incarcerated as well as access to care and coverage as they re-enter their communities.

We also advocate to eliminate other barriers to care, including prior authorizations, step edits, and deductibles.

Advocacy and Public Policy Engagement

We engage with policymakers and advocate organizations to support public policies that expand access to evidence-based treatment for opioid use disorder (OUD).

Our advocacy efforts are focused on advancing policies that support timely access to care and promote continuity of care across patient populations and care settings.

We also advocate for policies that improve coverage and reimbursement for OUD treatment across public and private payers, including Medicaid, as well as engage on policy issues affecting access to care for underserved and high-risk populations involved in the criminal justice system.

These efforts are intended to support a more effective, equitable treatment landscape for individuals living with OUD while reducing system level barriers that contribute to gaps in care.

Patient Access and Support Programs

We have various programs to help patients access our products.

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Medical Affairs Team

Our Medical Affairs Team, which supports HCPs and health administrators and includes Medical Science Liaisons and Medical Outcomes Value Liaisons responsible for responding to unsolicited off-label questions, clarifying data related to our products, working with study investigators, and developing and delivering real world evidence regarding the usage and potential benefits or risks of a medical product derived from an analysis of real-world data.

Our Medical Affairs team is separate from sales and marketing.

Our marketing efforts are focused on reaching the sufferers of the diseases that our products treat and the HCPs who treat them.

I n each of our markets, our commercial activities are supported by strategic planning, business analytics and measurement, and quarterly territory plans, ensuring that each market and sales territory is effectively resourced to maximize market access, and to increase appropriate use of our products.

In the U.S., our marketing team is responsible for developing marketing and sales materials, product websites, conference presentations and presence, and media plans which are reviewed by our Promotions Review Committee (PRC) consisting of medical, regulatory, and legal team members to assess compliance with rules and regulations as appropriate.

Our Medical Affairs Team, which supports HCPs and health administrators, includes Field Medical Advisors who are responsible for responding to unsolicited off-label questions, educating and disseminating data related to our products, working with study investigators, and developing and delivering real world evidence regarding the usage and potential benefits or risks of a medical product derived.

Our Medical Affairs team is separate and independent from sales and marketing.

Our marketing efforts are focused on reaching the sufferers of the diseases our products treat and the HCPs who treat them.

I n each of our markets, our commercial activities are supported by strategic planning, business analytics, and measurement ensuring that each market and sales territory is effectively resourced to maximize market access, and to increase appropriate use of our products.

In the U.S., our marketing team is responsible for developing marketing and sales materials, product websites, conference presentations, and media plans consisting of medical, regulatory, and legal team members to assess compliance with rules and regulations as appropriate.

We also provide reimbursement support for our U.S.

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We employ third-party vendors, such as advertising agencies, market research firms and suppliers of marketing and other sales support-related services, to assist with our commercial activities.

The challenges that we face in the sales process for our products include:

The challenges we face in the sales process for our products include:

• Understanding of the science that underpins the SUBLOCADE value propositions,

• Considerations related to buprenorphine being a controlled substance that is subject to regulation in the countries where our products are marketed,

• SUBLOCADE having been approved by the FDA with a REMS,

• SUBLOCADE requiring secure, refrigerated storage and the requirement that SUBLOCADE be administered by an HCP, and

• developing strategies to ensure market acceptance of OPVEE, competing with an established product, and serving customers, most of which are expected to be incremental to our existing customer base.

• SUBLOCADE having been approved by the FDA with a REMS, requiring that SUBLOCADE be administered by an HCP.

To assist our sales and marketing efforts, we invest in data infrastructure and related professionals to derive insights from our data.

These insights allow us to prioritize our marketing efforts, identify obstacles and barriers to treatment, and suggest new approaches.

We distribute our products in more than 30 countries.

Historically, we distributed our products in more than 30 countries.

Based on the country where sales originate, we derived 85% , 85% , and 83% of our net revenues from the U.S.

in 2025 , 2024 , and 2023 , respectively.

In the future, we expect to sell our products only in the U.S., Canada, Australia, France and Germany.

The distribution of our buprenorphine products is more complicated than other specialty pharmaceutical products because buprenorphine is regulated in the U.S.

as a Schedule III drug by the FDA, and similarly restricted by law enforcement authorities in the Most of World.

as a Schedule III drug by the FDA, and similarly restricted by law enforcement authorities in the Rest of World.

Additionally, certain products, like SUBLOCADE, utilize a restricted delivery network.

Additionally, to ensure proper administration, SUBLOCADE may only be administered by an HCP and are not dispensed to the patient directly.

To ensure that our products are available to HCPs and patients, we utilize specialty distributors and a network of several hundred specialty pharmacies that are equipped to adhere to these special requirements.

Additionally, to ensure proper administration, SUBLOCADE may only be administered by an HCP is not dispensed to the patient directly.

To ensure that our products are available to HCPs and patients, we utilize specialty distributors and a network of specialty pharmacies that are equipped to adhere to these special requirements.

The FDA requires a REMS for SUBOXONE Film and for SUBLOCADE Injection.

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Our largest customer in each year accounted for 20%, 19%, and 19% of our net revenues in 2025, 2024, and 2023, respectively.

These customers are our primary purchasers of SUBOXONE Film in the U.S., and as sales of SUBLOCADE grow, which is sold mostly through specialty pharmacies and specialty distributors, the relative importance of these three largest customers declines.

These customers are our primary purchasers of SUBOXONE Film in the U.S.

As sales of SUBLOCADE grow, mostly through specialty pharmacies and specialty distributors, the relative importance of these three largest customers declines.

Our fourth largest customer is one of these specialty pharmacies.

We use central third-party logistics and warehouses that comply with applicable local regulations for storage and distribution of our products into the supply chain.

Our third-party logistics provider specializes in integrated operations that include warehousing and transportation services that can be scaled and customized to our needs based on market conditions and the demands and delivery service requirements for our medicines and materials.

Their services eliminate the need to build dedicated internal infrastructures that would be difficult to scale without significant capital investment.

Our third-party logistics provider specializes in integrated operations including warehousing and transportation services that can be scaled and customized to our needs based on market conditions and the demands and delivery service requirements for our medicines and materials.

Their services eliminate our need to build dedicated internal infrastructure that would be difficult to scale without significant capital investment.

Our third-party logistics provider warehouses all medicines in controlled FDA-registered facilities in the U.S., or which meet applicable requirements outside the U.S.

Orders are prepared and shipped through an order entry system to ensure adequate supply and delivery of our medicines.

Most of World

Our commercial activities are currently focused on SUBLOCADE long-acting injectable (also called SUBUTEX Prolonged Release), SUBUTEX Tablet, SUBOXONE Tablet and SUBOXONE Film.

Depending on the size and d emands of the relevant markets, dedicated teams of clinical liaisons, health policy liaisons, or a combination of both, work to accelerate access to treatment for patients.

In Canada and in approved markets in Europe and Australia, we have a field force of sales specialists.

In markets where these products either are not approved or are unable to be promoted under local regulation, we have medical affairs personnel responsible for responding to medical information requests and for providing information consistent with local treatment protocols with respect to such products.

medical affairs personnel are separate from sales and marketing personnel.

In certain European markets, we have a sales team and a separate team of medical science liaisons supporting our rolling launches of SUBLOCADE and SUBOXONE Film.

Outside the U.S.

and Europe, we directly market SUBLOCADE, SUBOXONE Film, and SUBOXONE Tablets in in Canada and SUBLOCADE, SUBOXONE Film, and SUBUTEX Tablets in Australia.

We also utilize distributors in certain markets outside the U.S.

where we do not market our products directly.

Rest of World

Our commercial activities are currently focused on SUBLOCADE long-acting injectable, SUBUTEX Tablet, and SUBOXONE Film.

Depending on market size and d emands, dedicated teams of clinical liaisons, health policy liaisons, or a combination of both, work to accelerate access to treatment.

In Canada and in Australia, we have a field force of sales specialists.

consistent with local treatment protocols with respect to such products.

Such medical affairs personnel are separate from sales and marketing personnel.

In Canada we directly market SUBLOCADE and SUBOXONE Film.

In Australia, we directly market SUBUTEX Tablets.

Intellectual Property

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For example, the U.S., EU and Japan each provides for a minimum period of time after the approval of certain new drugs during which the regulatory agency may not rely upon the innovator’s data to approve a competitor’s generic copy.

For example, OPVEE enjoys regulatory exclusivity in the U.S.

through May 2026.

Regulatory exclusivity is also available in certain markets as incentives for research on new indications, orphan drugs (drugs that demonstrate promise for the diagnosis or treatment of rare diseases or conditions) and medicines that may be useful in treating pediatric patients.

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It is not possible to predict with certainty the length of market exclusivity for any of our branded products because of the complex interaction between patent and regulatory forms of exclusivity, the relative success or lack thereof of potential competitors’ experience in product development and inherent uncertainties concerning patent litigation.

There can be no assurance that a particular product will enjoy

market exclusivity for the full period of time that we currently estimate or that the exclusivity will be limited to the estimate.

There can be no assurance that a particular product will enjoy market exclusivity for the full period of time that we currently estimate or that the exclusivity will be limited to the estimate.

We also rely on trade secrets, know‑how and inventions, which are not protected by patents and try to protect this information by entering into confidentiality agreements with parties that have access to it, such as our corporate partners, collaborators, licensees, employees, and consultants.

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The patent rights listed below are those which are critical to our products:

Application or

SUBLOCADE Method 9,272,044

(application) 17/283,931

(application) 18/920,176 (application) PCT US2024/052003

(application) 18/931,350

Patent or Application No.

9,272,044 June 6, 2031

10,198,218 June 6, 2031

10,592,168 June 6, 2031

Formulation, Method of treatment 9,498,432 June 6, 2031

Formulation, Method of treatment 9,827,241 June 6, 2031

Formulation, Method of treatment 9,782,402 June 6, 2031

10,558,394 June 25, 2031

Formulation, Method of treatment 8,975,270 September 5, 2031

Formulation, Method of treatment 8,921,387 January 6, 2032

11,000,520 November 6, 2035

11,839,611 November 6, 2035

10,646,484 June 15, 2038

Means Plus Function

November 6, 2035

October 11, 2039

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October 18, 2044

Formulation 8,921,387

10,558,394 January 6, 2032

June 25, 2031

Means Plus Function (application) 17/985,253

November 6, 2035

Formulation and Methods 11,458,091

(application) 17/881,306

(application) 18/436,976

(application) 18/753,188

(application) 17/291,979

(application) 18/174,858

July 10, 2038

August 4, 2042

November 9, 2037

November 7, 2039

1 OPVEE enjoys regulatory exclusivity in the U.S.

through May 2026.

Licensed Technology

We own Patent No.

11,458,091, which includes claims covering combinations of nalmefene and Intravail ® (dodecyl maltoside, an absorption enhancer) in a nasal formulation which expires in 2038.

Our exclusive license agreement with Aegis Therapeutics obligates us to pay a tiered low to mid-single digit royalty on net sales, and a potential one- time sales milestone of $ 2 millions for OPVEE .

Indivior Global Integrity & Compliance Program

Indivior maintains a Corporate Compliance Program that has demonstrated effectiveness.

Key program elements include the following:

• Leadership & Governance:

Chief Integrity and Compliance Officer reporting directly to the CEO, program oversight by the Indivior Compliance Committee, and regular reporting and assurance provided to the Board of Directors.

• Independent Evaluation:

External consultants assess program effectiveness and benchmark against best practices.

• Resources & Expertise:

A well-resourced Integrity & Compliance team led by experienced professionals, including three senior leaders with over 50 years of combined healthcare compliance experience.

In addition to the experience and training, all team members hold professional certifications relevant to their responsibilities.

• Culture & Speak-Up:

The program applies behavioral science principles to promote ethical decision-making across the organization.

It also includes a robust ‘Speak-Up’ mechanism that empowers and encourages employees to report concerns or potential non-compliance confidentially and without fear of retaliation.

Anonymous reporting options are available to further support transparency and trust.

• Framework & Activities:

The Integrity & Compliance team oversees the Code of Conduct and healthcare compliance standards, conducts risk assessments, and implements and monitors key controls in alignment with government and industry guidance.

The Integrity & Compliance team collaborates with senior leadership to establish clear compliance expectations, reinforce a strong tone at the top, and ensures accountability for ethical conduct, as well as legal and regulatory adherence across all levels of the organization.

Regulatory Overview

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Pharmaceutical companies operate in a highly regulated environment.

In the U.S., we must comply with laws, regulations and other requirements promulgated by numerous federal and state authorities, including the FDA and other agencies and divisions of the Department of Health and Human Services, the Drug Enforcement Agency (“DEA”), and other agencies of the DOJ, the Consumer Product Safety Commission, the Environmental Protection Agency, the U.S.

Bureau of Customs and Border Protection (the “CBP”), and state agencies such as boards of pharmacy.

In the U.S., we must comply with laws, regulations and other requirements promulgated by numerous federal and state authorities, including the FDA and other agencies and divisions of the Department of Health and Human Services, the Drug Enforcement Administration (“DEA”), and other agencies of the DOJ, the Consumer Product Safety Commission, the Environmental Protection Agency, the U.S.

Customs and Border Protection (the “CBP”), and state agencies such as boards of pharmacy.

Applicable legal requirements govern to varying degrees the research, development, manufacturing, commercialization and sale of our prescription pharmaceutical products, including pre-clinical and clinical testing, approval, production, labeling, sale, distribution, import, export, post-market surveillance, advertising, dissemination of information and promotion.

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The FDA’s authority to regulate pharmaceuticals comes primarily from the Federal Food, Drug, and Cosmetic Act (“FFDCA”).

In addition to reviewing NDAs for branded drugs and additional new drug applications ("ANDAs") for generic drugs, the FDA has the authority to ensure that pharmaceuticals introduced into interstate commerce are neither “adulterated” nor “misbranded.” Adulterated means that the product or its manufacture does not comply with FDA quality and related standards.

In addition to reviewing NDAs for branded drugs and abbreviated new drug applications ("ANDAs") for generic drugs, the FDA has the authority to ensure that pharmaceuticals introduced into interstate commerce are neither “adulterated” nor “misbranded.” Adulterated means that the product or its manufacture does not comply with FDA quality and related standards.

A drug is adulterated if, among other things:

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The FDA classifies certain generic drugs as “therapeutically equivalent,” meaning that they are expected to have the same clinical effect and safety as the branded drug product.

Alternatively, a manufacturer may submit an NDA under FFDCA section 505(b)(2) for a drug product that has some differences from an already-approved drug product, but that relies in whole or in part on the findings of safety and/or effectiveness of a previously approved reference product, or on medical literature.

Alternatively, a manufacturer may submit an NDA under FFDCA section 505(b)(2) for a drug product that has some differences from an already-

approved drug product, but that relies in whole or in part on the findings of safety and/or effectiveness of a previously approved reference product, or on medical literature.

A section 505(b)(2) NDA must demonstrate that the proposed product is safe and effective notwithstanding the differences from the approved drug product.

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(vii) final FDA approval of the full prescribing information, labeling and packaging of the drug product;

(viii) in some cases, commitments to meet post-approval requirements, including ongoing monitoring and reporting of adverse events related to the drug product, implementation of a Risk Evaluation and Mitigation Strategy ("REMS") program, if applicable, and conduct of any agreed post-marketing requirement or post-marketing commitment studies.

(viii) in some cases, commitments to meet post-approval requirements, including ongoing monitoring and reporting of adverse events related to the drug product, implementation of a REMS program, if applicable, and conduct of any agreed post-marketing requirement or post-marketing commitment studies.

Clinical trials are typically conducted in four sequential phases, although they may overlap.

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(iv) Phase IV studies are conducted following approval.

In some cases, the FDA requires post marketing requirement studies or post-marketing commitment studies after the NDA has been approved.

In some cases, the FDA requires post marketing requirement studies or post-marketing commitment studies after the NDA has been

Such post-marketing clinical studies or surveillance programs are intended to obtain more information about the risks of harm, benefits and optimal use of the drug product by evaluating the results of the drug product in a larger number of patients.

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In addition, under the Pediatric Research Equity Act 2003 ("PREA") as amended, all NDAs must include assessments on a drug in pediatric patients unless the applicant receives a waiver or deferral.

A drug sponsor may also seek to conduct a clinical trial of a drug product on pediatric patients based on a written request from the FDA in order to obtain a form of marketing exclusivity as permitted under the Best

Pharmaceuticals for Children Act 2002, as amended.

Under PREA, FDA may require post-approval studies assess the safety and effectiveness of the indication in pediatric patients.

Under PREA, FDA may require post-approval studies to assess the safety and effectiveness of the indication in pediatric patients.

The path leading to FDA approval of a section 505(b)(2) NDA for a drug product that has differences from an already approved product is somewhat shorter.

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fiscal year 2026, the user fee rate is set at $1,918,377 for an ANDA submitted by a large size operation generic applicant.

The FDA will also collect from generic drug manufacturers a separate fee where they reference a so-called Drug Master File for a contract manufacturer, and separate annual manufacturing facility fees for API and finished drug products.

The FDA will also

collect from generic drug manufacturers a separate fee where they reference a so-called Drug Master File for a contract manufacturer, and separate annual manufacturing facility fees for API and finished drug products.

Aside from the backlog described above, the timing of FDA approval of ANDA filings depends on other factors, including whether an ANDA holder has challenged any listed patents to the reference listed drug (the “RLD”) and whether the RLD is entitled to one or more periods of non-patent data or marketing exclusivity under the FFDCA, as discussed elsewhere in this section.

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Any person that files a section 505(b)(2) NDA that relies upon reference to an approved NDA for which the patents are listed, or an ANDA to secure approval of a generic version of the previously approved drug, must make a certification in respect of listed patents.

If the ANDA or section

505(b)(2) NDA applicant certifies that there are no listed patents or that the listed patents have expired, the FDA may approve the application immediately.

If the ANDA or section 505(b)(2) NDA applicant certifies that there are no listed patents or that the listed patents have expired, the FDA may approve the application immediately.

If the applicant certifies that the patents have not expired, the FDA may only approve the application upon expiry of the patents.

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The FDA has the authority to require the manufacturer to provide a REMS that is intended to ensure that the benefits of a drug product (or class of drug products) outweigh the risks of harm.

The FDA may require that a REMS include elements to assure safe use to mitigate a specific serious risk of harm, such as requiring that prescribers have particular training or experience or that the drug product is dispensed in certain healthcare settings.

The FDA may require a REMS include elements to assure safe use to mitigate a specific serious risk of harm, such as requiring that prescribers have particular training or experience or that the drug product is dispensed in certain healthcare settings.

The FDA has the authority to impose civil penalties on or take other enforcement action against any drug manufacturer who fails properly to implement an approved REMS.

Separately, there are prohibitions on a drug manufacturer using an approved REMS to delay generic competition.

Separately, drug manufacturers are prohibited from using an approved REMS to delay generic competition.

The FDA has been active in instituting class-wide and product-specific REMS for opioid drug products.

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The goal of the SUBLOCADE REMS program is to mitigate the risk of serious harm or death that could result from intravenous self-administration by ensuring healthcare settings and pharmacies are certified and only provide SUBLOCADE directly to a healthcare provider for administration by a healthcare provider to the patient.

Other products for which the Company secures NDA approval in the U.S.

in the future may become subject to a REMS specific to the product or shared with other products in the same class of drug, if the FDA determines that additional steps beyond labeling are required to help ensure the benefits of the medication outweighs its risks.

Other products in development may become subject to a REMS specific to the product or shared with other products in the same class of drug, if the FDA determines that additional steps beyond labeling are required to help ensure the benefits of the medication outweighs its risks.

Quality assurance requirements

The FDA enforces requirements to ensure that the methods used in, and the facilities and controls used for, the manufacture, processing, packaging, and holding of drugs conform to cGMP.

The cGMP requirements that the FDA enforces are comprehensive and cover all aspects of manufacturing operations, from receipt of raw materials to finished product distribution, and are designed to ensure that the finished products meet all the required identity, strength, quality, and purity characteristics.

Ensuring compliance requires a continuous commitment of time, money, and effort in all operational areas.

The FDA enforces requirements to ensure the methods used in, and the facilities and controls used for, the manufacture, processing, packaging, and holding of drugs conform to cGMP.

The cGMP requirements enforced by the FDA are comprehensive, covering all aspects of manufacturing operations, from receipt of raw materials to finished product distribution, and are designed to ensure that finished products meet all the required identity, strength, quality, and purity characteristics.

Ensuring compliance requires an on-going commitment of time, money, and effort in all operational areas.

The FDA conducts pre-approval and post-approval inspections of facilities engaged in the development, manufacture, processing, packaging, testing, and holding of the drugs subject to NDAs and ANDA filings.

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Adverse inspections can lead to FDA inspection observations, warning letters, seizure, recalls, injunctions, and shutdown of facilities.

In addition, where products or components for manufacturing are being imported into the U.S., the FDA may issue an import alert to prevent shipments into the country.

In addition, if the FDA concludes that a company is not in compliance with cGMP requirements, sanctions may be imposed that include preventing that company from receiving the necessary licenses to export its products, preventing further approvals for applications involving the facility or facilities and issue and classifying that company as an “unacceptable supplier,” thereby disqualifying that company from selling products to governmental agencies.

Additionally, where products or components for manufacturing are being imported into the U.S., the FDA may issue an import alert to prevent shipments into the country.

If the FDA concludes a company is not in compliance with cGMP requirements, sanctions may be imposed that include preventing that company from receiving the necessary licenses to export its products, preventing further approvals for applications involving the facility or facilities and issue and classifying that company as an “unacceptable supplier,” thereby disqualifying that company from selling products to governmental agencies.

Reporting requirements

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Manufacturers are required to file copies of all product-specific promotional materials with the FDA’s Office of Prescription Drug Promotion at the time of their first use.

Failure to implement a robust internal company review process and to comply with FDA requirements regarding labeling and promotion increases the risk of enforcement action by the FDA, the DOJ, or the states.

In addition, the FDA has the authority to require labeling changes after approval of a drug if it becomes aware of new safety information.

Failure to implement a robust internal company review process and to comply with FDA requirements

regarding labeling and promotion increases the risk of enforcement action by the FDA, the DOJ, or the states.

The FDA has the authority to require labeling changes after approval of a drug if it becomes aware of new safety information.

Import and export requirements

To import pharmaceuticals into the U.S., the importer must file an entry notice and bond with the Customs and Board Protection (“CBP”).

To import pharmaceuticals into the U.S., the importer must file an entry notice and bond with the U.S.

Customs and Board Protection (“CBP”).

All drugs are subject to FDA examination before release by the CBP.

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If the FDA ultimately refuses admission, the CBP may issue a notice for redelivery and assess liquidated damages for up to three times the value of the drugs.

Products for export from the U.S.

Products exported from the U.S.

are subject to foreign countries’ import requirements and the exporting requirements of the FDA.

For example, international sales of drugs manufactured in the U.S.

that are not approved by the FDA for use in the U.S.

not approved by the FDA for use in the U.S.

are subject to FDA export requirements.

FDA will provide a

certificate of pharmaceutical product ("eCPP") directly to a requesting country to provide assurance that the product has been approved for export from the U.S.

FDA will provide a certificate of pharmaceutical product ("eCPP") directly to a requesting country to provide assurance that the product has been approved for export from the U.S.

and that the manufacturing facilities are in compliance with cGMP.

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Drug Enforcement Administration

Drug Enforcement Agency (“DEA”) is the federal agency in the U.S.

Drug Enforcement Administration (“DEA”) is the federal agency in the U.S.

responsible for enforcement of the Controlled Substances Act (“CSA”).

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The federal and state governments may continue to enact measures in the future aimed at containing or reducing payment levels for prescription pharmaceuticals paid for in whole or in part with government funds.

In the new Congress convening in 2025, federal policy makers may offer proposals to reform the Medicaid program, which could affect the pharmaceutical industry.

Federal policy makers may offer proposals to reform the Medicaid program, which could affect the pharmaceutical industry.

From time to time, legislative or regulatory changes are made to government healthcare programs that impact our business.

For example, the Medicare Prescription Drug Improvement and Modernization Act

2003 (“Medicare Part D”) created a new outpatient prescription drug coverage program for people with Medicare through a new system of private market drug benefit plans.

For example, the Medicare Prescription Drug Improvement and Modernization Act 2003 (“Medicare Part D”) created a new outpatient prescription drug coverage program for people with Medicare through a new system of private market drug benefit plans.

This law provides an outpatient prescription drug benefit to seniors and individuals with disabilities in the Medicare program.

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In addition, state laws governing the privacy and security of health information in certain circumstances, including laws addressing behavioral health diagnosis and treatment—many of which are not pre-empted by HIPAA—differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

Medicaid Services (CMS) information related to payments or other transfers of value made to physicians, advanced practice providers, and teaching hospitals.

The federal Physician Payments Sunshine Act (Sunshine Act) requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services (CMS) information related to payments or other transfers of value made to physicians, advanced practice providers, and teaching hospitals.

The Sunshine Act also requires applicable manufacturers and applicable group purchasing organizations to report annually to CMS ownership and investment interests held by physicians and their immediate family members.

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Because of the breadth of these laws and the narrowness of available statutory exceptions and regulatory safe harbors, it is possible that some of our business activities could be subject to challenge under one or more of such laws.

If we were found to be in violation any of the federal and state laws described above or any other governmental regulations that apply to us, including any violation of the CIA, we may be subject to significant criminal, civil and administrative penalties including damages, fines, imprisonment, disgorgement, contractual damages, reputational harm, diminished profits and future earnings, disgorgement, exclusion from participation in government healthcare programs and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

If we were found to be in violation any of the federal and state laws described above or any other governmental regulations that apply to us, we may be subject to significant criminal, civil and administrative penalties including damages, fines, imprisonment, disgorgement, contractual damages, reputational harm, diminished profits and future earnings, disgorgement, exclusion from participation in government healthcare programs and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

We must comply with the FCPA worldwide and similar anti-bribery laws in non-U.S.

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If we fail to comply, or have not fully complied, with such laws, we could face substantial penalties.”

European Union and U.K.

In the EU and U.K., medicinal products are subject to extensive pre- and post-marketing regulation by regulatory authorities at both the EU and national levels.

European Union

In the EU, medicinal products are subject to extensive pre- and post-marketing regulation by regulatory authorities at both the EU and national levels.

Additional rules also apply at the national level relating specifically to controlled substances.

Following a referendum in 2016, the U.K.

formally left the EU on January 31, 2020 and the transition period, during which EU laws continued to apply to the U.K., expired on December 31, 2020.

A significant proportion of the regulatory framework in the U.K.

applicable to medicinal products is currently derived from European Union Directives and Regulations, and since January 1, 2021, the EU laws which have been transposed into U.K.

law through secondary legislation continue to be applicable in the U.K.

as retained EU law, although any new EU law developments have ceased to apply in the U.K.

from that date.

The divergence between the U.K.

and the EU regimes may increase as time passes, including for example, with respect to EU law developments to which the U.K.

is not subject, such as the Clinical Trials Regulation.

There have been no new significant legislative enactments in the U.K.

since its exit from the EU with respect to medicinal products which would materially deviate the U.K.’s overall regulatory position from the EU law at the time the U.K.

exited the EU.

However, there are important procedural and other differences, such as the requirement to obtain a U.K.-specific marketing authorization, for example.

There are several ongoing U.K.

government consultations relevant to medicinal products, most notably with respect to clinical trials and the future regulatory landscape in the U.K.

is uncertain.

The position in Northern Ireland differs in certain respects from that of the rest of the United Kingdom (England, Scotland, and Wales) as Northern Ireland has chosen to retain some EU rules following the U.K.’s departure from the EU.

Clinical trials and marketing approval

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The EU Regulation on Clinical Trials provides for certain transitional rules for clinical trials applied for before it came into effect and gives sponsors a choice as to whether to apply the previous rules until January 31, 2023.

regulatory framework in relation to clinical trials is derived from secondary national U.K.

legislation implementing the EU Directive 2001/20/ EC.

is not subject to the new EU Regulation on Clinical Trials and the details of the future regulation of clinical trials in the U.K.

are as yet uncertain.

After completion of the required clinical testing, a drug manufacturer must obtain a marketing authorization in line with Regulation EC 726/2004 (and as transposed into national laws) before it may place its medicinal product on the market in the EU.

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The two-year period may be extended to three years if during the first eight years a new therapeutic indication with significant clinical benefit over existing therapies is approved.

In the U.K., the EU centralized procedure described above no longer applies and a separate application will be required to the U.K.

Medicines and Healthcare products Regulatory Agency (“MHRA”) for a U.K.

marketing authorization.

The MHRA may consider marketing authorizations approved in the European Economic Area (EEA) member states through decentralized or mutual recognition procedures, which may accelerate the process of granting a marketing authorization in the U.K.

In the EU, companies developing a new medicinal product must agree to a Pediatric Investigation Plan (“PIP”) with the EMA and must conduct pediatric clinical trials in accordance with that PIP unless a waiver applies, for example because the relevant disease or condition occurs only in adults.

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This pediatric reward is subject to specific conditions and is not automatically available when data in compliance with the PIP are developed and submitted.

In the U.K., after January 1, 2021, PIP applications were required to be submitted separately to the MHRA though EU PIPs agreed prior to that date were adopted as U.K.

PIPs as at that date.

MHRA PIP application system mirrors the EU system and the MHRA has said it will continue to follow the EU guidelines on such applications.

The MHRA will take account of whether an EU PIP is already granted when deciding whether to grant a U.K.

The MHRA strongly encourages parallel submission to EMA and MHRA.

Pharmacovigilance and risk management

The holders of a marketing authorization are subject to extensive pharmacovigilance and risk management obligations under Directive 2001/83/EC and Regulation EC 726/2004.

According to EMA, pharmacovigilance “is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.” In the EU and the U.K., the holders of a marketing authorization must establish and maintain a pharmacovigilance system with the overall aim to monitor and ensure the safety of a medicinal product and appoint an individual qualified person for pharmacovigilance who is responsible for oversight of that system.

According to EMA, pharmacovigilance “is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.” The holders of a marketing authorization must establish and maintain a pharmacovigilance system with the overall aim to monitor and ensure the safety of a medicinal product and appoint an individual qualified person for pharmacovigilance who is responsible for oversight of that system.

They are also required to establish and maintain a pharmacovigilance system master file detailing the pharmacovigilance system.

On request, the system master file must be made available to the competent authorities for inspection.

In the U.K., if the qualified person does not reside or operate in the U.K., there will need to be a national pharmacovigilance contact person who does reside or operate in the U.K.

Key pharmacovigilance obligations include the recording of suspected serious adverse reactions to the medicinal product in and outside the EU and promptly reporting them through the centralized EudraVigilance database.

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Promotional restrictions

In the EU and U.K., all advertising and promotional activities for the product must be consistent with the approved summary of product characteristics, and therefore all off-label promotion is prohibited.

In the EU, all advertising and promotional activities for the product must be consistent with the approved summary of product characteristics, and therefore all off-label promotion is prohibited.

Direct-to-consumer advertising of prescription medicines is also prohibited.

Although general requirements for advertising and promotion of medicinal products are established under EU and U.K.

legislation, the details are governed by national regulations and can differ from one country to another.

Although general requirements for advertising and promotion of medicinal products are established under EU legislation, the details are governed by national regulations and can differ from one country to another.

Manufacturing and importing

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Manufacturing facilities are subject to periodic inspections by the competent authorities for compliance with EU GMP and may, if products are produced for another market, also be subject to inspections under the GMP requirements applicable in that market.

The position in the U.K.

is broadly equivalent, save that a U.K.

specific manufacturer’s license is required from the MHRA (in addition to the U.K.

marketing authorization), which also requires compliance with EU GMP.

For the purposes of EU legislation, the U.K.

is now classified as a “third country.”

The manufacture, import, export, storage, distribution, and sale of controlled substances are subject to additional regulation at the national level in the EU and U.K.

The manufacture, import, export, storage, distribution, and sale of controlled substances are subject to additional regulation at the national level in the EU.

In many EU member states, the regulatory authority responsible for medicinal products is also responsible for controlled substances.

and in certain EU member states, responsibility is split and in the U.K., the Home Office is responsible for controlled substances while the MHRA is responsible for medicinal products.

Generally, any company manufacturing or distributing a medicinal product containing a controlled substance in the EU or U.K.

will need to hold a controlled substances license from the competent national authority and will be subject to specific record-keeping and security obligations.

Generally, any company manufacturing or distributing a medicinal product containing a controlled substance in the EU will need to hold a controlled substances license from the competent national authority and will be subject to specific record-keeping and security obligations.

Separate import or export certificates are required for each shipment into or out of the country.

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However, the member states must at least comply with the Transparency Directive (Directive 89/105/EEC), which primarily provides procedural obligations.

Governments influence the price of medicinal products in the EU and the U.K.

through pricing and reimbursement rules and control of national healthcare systems that fund a large part of the cost of those products to patients.

Governments influence the price of medicinal products in the EU through pricing and reimbursement rules and control of national healthcare systems that fund a large part of the cost of those products to patients.

Some member states operate positive and negative list systems under which products may only be marketed once a reimbursement price has been agreed.

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In addition, in most European countries, physicians are encouraged or even required to prescribe generic rather than branded products and many governments also advocate generic substitution by requiring or permitting pharmacists to substitute a different company’s generic version of the branded drug product that was originally prescribed.

Most of World

Rest of World

Current markets

After the U.S.

and Europe, our largest markets are Canada and Australia, where we market our products pursuant to standards set by Health Canada and the Therapeutic Goods Administration, respectively.

After the U.S., our largest markets are Canada and Australia, where we market our products pursuant to standards set by Health Canada and the Therapeutic Goods Administration, respectively.

We also market our products in certain other developed countries.

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however, these aspects of the process are tightly controlled and, we believe, represent low risk to the surrounding environment.

Our approximate 80,000 square foot manufacturing plant in Raleigh, N.C.

currently manufactures pharmaceutical products only for third party customers.

Unlike the FCP, the Raleigh Manufacturing Facility does not use hazardous chemicals as part of its manufacturing processes at this time.

Our manufacturing plant in Raleigh, N.C.

currently is performing trial runs in anticipation of future manufacture of SUBLOCADE.

It uses hazardous materials as part of the manufacturing process;

these aspects of the process are tightly controlled and, we believe, represent low risk to the surrounding environment.

Our operations, like those of other pharmaceutical companies, involve the use of substances regulated under environmental laws, primarily in manufacturing processes and, as such, we are subject to numerous federal, state, local and non-U.S.

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At Indivior, we value our distinctive culture and believe it is a key source of sustainable competitive advantage.

Our 50+ person Culture Champions network is well established and has helped us to implement many initiatives aimed at strengthening and building our culture.

Our Culture Champions network is well established and has helped us to strengthen and build our culture.

We also conduct an annual survey of employees to monitor engagement levels and act on feedback received through this process.

In 2024, we remained certified as a Great Place To Work for all countries entered.

The table below sets forth the average monthly number of persons employed by the Company, excluding Directors, by business function during the years indicated.

Business function 2024

Operations 811 735 675

Management 225 208 178

Research and development 116 108 75

Average number of employees 1,152 1,051 928

As of December 31, 2025, the Company employed 838 people worldwide, of which 827 were full-time employees.

Of these, 747 were located in the U.S., 274 were located in Europe, the Middle East, Africa, or Canada, and 30 were located in Australia.

Certain of our employees are represented by unions or works councils.

Of these, 593 were located in the U.S., and 245 were located outside the U.S.

Certain of our employees outside of the U.S.

are represented by unions or works councils.

We believe that we have a good relationship with our employees and with the unions and works councils that represent certain employees.

As of December 31, 2024, women or minorities held 31% (4 of 13) of the seats on our Board of Directors.

As of December 31, 2024, 51% of our employees were women.

Additionally, 34% of senior managers (including members of our Executive Committee who are not directors of Indivior PLC and directors of each subsidiary company) were women.

Other Information and Corporate Governance

The Company’s legal name is Indivior PLC.

Indivior PLC is a public limited company incorporated under the laws of England and Wales that was incorporated on September 26, 2014.

The principal legislation under which the Company operates is the U.K.

Companies Act 2006.

The registered office address of Indivior PLC is:

234 Bath Road, Slough, Berkshire, U.K., SL1 4EE and its telephone number is +1 (804) 379-1090.

The Company’s legal name is Indivior Pharmaceuticals, Inc.

Indivior Pharmaceuticals, Inc.

is a Delaware corporation that was incorporated on October 28, 2025.

The registered office address of Indivior Pharmaceuticals, Inc.

is 8 The Green, Ste R, Dover, DE 19901.

The Company’s headquarters is located at 10710 Midlothian Turnpike, Suite 125, North Chesterfield, VA 23235, and its telephone number is +1 (804) 379-1090.

The Company’s website is https://www.indivior.com/.

Information on the Company’s website does not constitute a part of and is not incorporated by reference into this Annual Report.

Our ordinary shares are listed on the Global Select Market of The Nasdaq Stock Market LLC and on the Equity Shares (Transition) category of the London Stock Exchange under the ticker symbol “INDV.”

The Company is subject to the information reporting requirements of the Exchange Act applicable to foreign private issuers, and under those requirements files reports with the SEC.

Our common stock is listed on The Nasdaq Stock Market LLC under the ticker symbol “INDV.”

The Company is subject to the information reporting requirements of the Exchange Act and under those requirements files reports with the SEC.

The SEC maintains a website at http://www.sec.gov from which this Annual Report and those other reports or other information may be accessed.

We also make our electronic filings with the SEC available at no cost on the Company’s website, www.indivior.com/en/investors , as soon as reasonably practicable after we file such material with, or furnish it to, the SEC.

Upon the filing of this Annual Report on Form 10-K, the Company has assumed an obligation to file annual reports on Form 10-K, quarterly reports on Form 10-Q, and file or furnish Current Reports on Form 8-K rather than reports on Form 6-K.

Foreign Private Issuer Status

As a foreign private issuer, we are exempt from the rules under the Exchange Act related to the furnishing and content of proxy statements, and our officers, directors, and principal shareholders are exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act.

We provide information with respect to our Board of Directors, Executive Officers, and corporate governance policies and principles on our website, www.indivior.com/en/about-us.

Specifically, the Company makes available on its website, under the headings "About Us — Corporate Governance" (i) its codes of conduct or ethics for the Board, senior financial officers, and employees, and (ii) the committee charters of the Company’s board committees.

If the Company makes changes in, or provides waivers from, the provisions of any of its codes of ethics that the SEC requires it to disclose, the Company intends to disclose these events in the " Corporate Governance " section of its website.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business