NASDAQ: INDV

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 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

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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. The U.S. 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

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 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.

Product Development

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

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. in 2003. 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. 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.

Launch of SUBLOCADE in the U.S.

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

In addition to our commercially available products, our product pipeline includes two new drug candidates for the treatment of OUD.

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Agreements with DOJ, FTC and HHS-OIG Regarding Marketing and Promotional Practices

In 2020 the Company and certain of its subsidiaries reached agreements with the DOJ, the U.S. Federal Trade Commission (“FTC”), the U.S. Attorney’s Office for the Western District of Virginia, and U.S. state attorneys general to resolve potential criminal and civil liability arising from an indictment brought in 2019 by a grand jury in the Western District of Virginia, a civil lawsuit in which the DOJ partially intervened and an investigation by the FTC, all of which generally concerned Indivior, Inc. and certain of its subsidiaries’ marketing and promotional practices related to SUBOXONE Film and SUBOXONE Tablet. The 2019 indictment followed a federal criminal grand jury investigation that began in 2013.

As part of the agreement with the DOJ (“Resolution Agreement”), a wholly owned subsidiary of Indivior PLC pleaded guilty to a single count of making false statements relating to healthcare matters in 2012 in violation of 18 U.S.C. Section 1035 related to SUBOXONE Film and was excluded from participating in government healthcare programs. 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. 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. Mr. Ciaffoni also serves on our Board of Directors. In addition:

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

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

Label Expansion for SUBLOCADE

On February 24, 2025, we announced that the U.S. Food and Drug Administration (FDA) approved label changes in the U.S. for SUBLOCADE including a rapid initiation protocol and alternative injection sites. 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. 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 may streamline the course of treatment and improve integration into different healthcare environments. For more information, see "Indivior Products—SUBLOCADE," 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.

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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.

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

Industry Overview

Substance Use and its Impact

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. 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.

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.

Substance Use Disorder: The Disease

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.

Since SUD is marked by periods of recovery and symptom recurrence, or relapse, it resembles other chronic diseases like hypertension and type-2 diabetes. These diseases are lifelong conditions that require continual effort to manage. 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.

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In the U.S. 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; people begin using substances for many reasons and one person’s path to addiction may look drastically different from that of another. 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 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.

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 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.

Approximately 10% of Canadian adults who used opioid medications, or 351,000 persons, reported problematic use, according 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.

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 “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. MOUD is primarily used for the treatment of addiction to opioids such as heroin and prescription pain relievers that contain opiates. The prescribed medication normalizes brain chemistry, blocks the euphoric effects of opioids, relieves physiological cravings, and normalizes body functions without the negative and euphoric effects of the substance. MOUD has been shown to be more effective than medication or counseling alone in treating OUD. A common misconception about MOUD is that some of the medicines used simply substitute one drug for another. However, these medications may

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restore healthy brain function, which leads to improvements in behaviors associated with addiction. Longer-term use of these medications is associated with improved outcomes.

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. 2023). 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. 2023; Craft WH, et al., Addiction 2023).

Treatment access

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. 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.

Indivior Products

Our marketed products are described below:

Product

Active

Ingredient(s)

Delivery

Method

Main

Markets

20251 Global

Net Sales

(in millions)

Long-Acting Injectable
$856

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

and Canada

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,

and Canada

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

(1) See “Item 7. Management's Discussion & Analysis—Operating Results” for data for each of the last three financial years.

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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, 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:

•Patients would likely experience substantially reduced levels of cravings associated with addiction;

•Patients should receive no gratification from abuse of opioids;

•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;

•For physicians and wider society, there should be reduced levels of potential diversion and abuse compared to sublingual buprenorphine—once injected, the buprenorphine cannot easily be extracted and diverted; and

•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. 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.

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, 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

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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.

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. 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 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 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 2012 and in Australia in 2014. SUBOXONE Film was also approved in the U.S. 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 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.

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SUBOXONE Tablet (buprenorphine and naloxone) sublingual tablet

SUBOXONE Tablet is a fixed-dose combination of buprenorphine and naloxone in the ratio of four parts buprenorphine to one part naloxone. SUBOXONE Tablet was designed to discourage intravenous abuse of the tablet formulation in patients dependent on full opioid agonists (e.g., heroin and morphine). Naloxone is a potent antagonist at opioid receptors. 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 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 2013.)

Discontinuation of Marketing and Promotion of PERSERIS

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. in 2019. 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

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. 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.

Competition

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, 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, 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. as discussed above. In contrast, no generic competition is present in Australia. In Europe and Canada, SUBOXONE Film enjoys patent protection until 2030.

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. 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

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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 (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. See Heidbreder C, Fudala PJ, Greenwald MK (2023) History of the discovery, development, and FDA-approval of buprenorphine medications for the treatment of opioid use disorder. Drug and Alcohol Dependence Reports. https://doi.org/10.1016/j.dadr.2023.100133. Indivior has built a portfolio of treatments for OUD and a pipeline of new molecules. Indivior launched the first buprenorphine-based medication for the treatment of OUD in France in 1996. 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 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.

Pipeline

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

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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 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 results in the second quarter of 2026. The current U.S. patents for INDV-6001 expire in 2039.

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

The Company sources a large portion of its active pharmaceutical ingredients ("API") from its own manufacturing facilities. 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. and require permits for import and export. An annual importation assessment value for buprenorphine and products containing buprenorphine is set by each importing country through the International Narcotics Control Board (the “INCB”). Once the assessment value has been reached for a given country, no additional import permits may be issued unless proper justification for an assessment value increase is provided to the respective country’s governing body, which reports to the INCB. 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.

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SUBLOCADE

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. 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 “