Indivior Pharmaceuticals, Inc.

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 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:

•SUBLOCADE (buprenorphine extended-release monthly injection); and

•SUBOXONE Film (buprenorphine and naloxone sublingual film);

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 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. 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.

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 andpromotional 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 ofthe 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—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.

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.

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 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:

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