Jails outpace prisons in offering MOUD, but regional disparities and limited treatment access persist across the U.S.Qualitative feedback points to need for greater reentry support, housing, care coordination, and provider training RICHMOND, Va., March 17, 2026 (GLOBE NEWSWIRE) -- Indivior Pharmaceuticals Inc. (Nasdaq: INDV) announced results from a cross-sectional survey published in the Journal of Correctional Health Care that reveal critical gaps in the availability of medications for opioid use disorder ...

Core Viewpoint - Indivior Pharmaceuticals, Inc. has announced the pricing of a $450 million offering of 0.625% convertible senior notes due 2031, which was increased from an initial offering size of $400 million, with a potential additional $50 million option for initial purchasers [1][4]. Group 1: Offering Details - The notes will be senior, unsecured obligations with an interest rate of 0.625% per annum, payable semi-annually starting September 15, 2026, and maturing on March 15, 2031 [2]. - The initial conversion rate is set at 24.0033 shares of common stock per $1,000 principal amount of notes, translating to an initial conversion price of approximately $41.66 per share, representing a 35% premium over the last reported sale price on March 12, 2026 [2]. - The notes are redeemable at Indivior's option starting March 20, 2029, under certain conditions, including if the stock price exceeds 130% of the conversion price for a specified period [3]. Group 2: Use of Proceeds - Indivior estimates net proceeds from the offering to be approximately $437.7 million, or $486.4 million if the additional notes option is fully exercised [4]. - The company plans to use about $239 million to repay borrowings under its term loan and revolving credit facility, $75 million for repurchasing approximately 2.4 million shares of common stock, and the remainder for general corporate purposes [4][5]. Group 3: Company Background - Indivior is a leader in long-acting injectable treatments for opioid use disorder (OUD), focusing on evidence-based treatment and advancing the understanding of OUD as a chronic but treatable brain disease [8]. - The company has a history of over 25 years in addiction medicine, aiming to help individuals achieve long-term recovery with dignity [8].

Core Insights - Indivior Pharmaceuticals is a key player in long-acting injectable treatments for opioid use disorder (OUD), focusing on evidence-based solutions like SUBLOCADE, which is a monthly injectable form of buprenorphine aimed at improving patient outcomes and reducing healthcare costs [1] - A recent study indicates that patients adhering to SUBLOCADE for 12 months experienced a 42% reduction in non-MOUD medical costs, supporting the company's strategy to evaluate OUD treatment based on total healthcare costs [1] Financial Performance - Indivior's stock (INDV) has a price-to-earnings (P/E) ratio of 18, reflecting investor confidence in its earnings potential [2] - The company faces financial challenges, indicated by a negative enterprise value to operating cash flow ratio of -207.20 and a debt-to-equity ratio of -3.58, suggesting potential difficulties in cash flow generation and financial structuring [2] - The current ratio of 0.71 indicates that Indivior may struggle to cover short-term liabilities with its short-term assets [3] Industry Position - Despite financial challenges, Indivior's focus on long-acting injectable treatments and evidence-based care positions it as a leader in addressing OUD, which is recognized as a chronic but treatable brain disease [3]

RICHMOND, Va., March 12, 2026 (GLOBE NEWSWIRE) -- Indivior Pharmaceuticals, Inc. (Nasdaq: INDV) today announced its intention to offer, subject to market and other conditions, $400,000,000 aggregate principal amount of convertible senior notes due 2031 (the “notes”) in a private offering to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). Indivior also expects to grant the initial purchasers of the not ...

Patients adherent to SUBLOCADE® for 12 months had 42% lower adjusted non-MOUD medical costs vs. those adherent to other forms of MOUDPatients adherent to SUBLOCADE had the lowest inpatient, emergency department, and detoxification utilization across all treatment groups RICHMOND, Va., March 11, 2026 (GLOBE NEWSWIRE) -- Indivior Pharmaceuticals (Nasdaq: INDV) today announced findings from a new real-world evidence, retrospective observational study published in Frontiers in Public Health showing that adheren ...

Product Development and Clinical Trials - The company secured global rights (excluding China, Taiwan, Hong Kong, and Macau) for INDV-6001, a three-month LAI buprenorphine, with an upfront payment of $10 million and a $5 million option payment in Q1 2023[110]. - The company expects to announce results for the INDV-6001 Phase 2 study in Q2 2026, with the last patient visit occurring in Q4 2025[110]. - The company announced dosing of the first subject with INDV-2000 in June 2024, a non-opioid treatment for moderate to severe OUD, with results expected in Q2 2026[111]. Market and Revenue - Approximately 85% of the company's net revenues are derived from the U.S. market, highlighting its significance for profitability[121]. - The three largest customers accounted for 51%, 55%, and 54% of global net revenues in 2025, 2024, and 2023, respectively, with the largest customer contributing 20%, 19%, and 19% in those years[143]. Regulatory Compliance and Risk Management - The FDA requires a REMS for both SUBOXONE Film and SUBLOCADE Injection to mitigate risks associated with their use[141]. - The regulatory environment requires substantial time and financial resources for compliance with laws and regulations, impacting the research, development, and commercialization of pharmaceutical products[156]. - The FDA mandates that new drug products must undergo a rigorous approval process, including clinical trials and compliance with Good Manufacturing Practices (GMP)[161]. - The company’s compliance program includes leadership oversight, independent evaluations, and a culture that encourages ethical decision-making and reporting of concerns[154]. - The DEA requires drug manufacturers to implement a system to identify suspicious orders of controlled substances[187]. - The FDA may impose civil penalties on manufacturers who fail to implement an approved REMS[174]. - The FDA conducts pre-approval and post-approval inspections to ensure compliance with cGMP, and adverse inspections can lead to significant regulatory actions[179]. Market Access and Distribution - The company has coverage from approximately 90% of payors for its OUD products, including nearly all commercial insurance payors and Medicaid[122]. - The company is focused on expanding access to its products in organized health systems and criminal justice systems, which are key channels for its offerings[124][125]. - The company utilizes specialty distributors and pharmacies to ensure compliance with regulations for the distribution of buprenorphine products[140]. - The company utilizes third-party logistics providers to manage warehousing and distribution, ensuring compliance with FDA regulations and eliminating the need for significant capital investment in internal infrastructure[144]. - Commercial activities are focused on SUBLOCADE long-acting injectable, SUBUTEX Tablet, and SUBOXONE Film, with dedicated teams working to accelerate access to treatment based on market demands[145]. Intellectual Property and Market Exclusivity - The company holds several patents critical to its products, with key patents for SUBLOCADE expiring between June 6, 2031, and October 18, 2044[153]. - The company relies on trade secrets and confidentiality agreements to protect proprietary information not covered by patents[152]. - The company estimates market exclusivity periods for its branded products on a case-by-case basis, acknowledging uncertainties in patent and regulatory interactions[151]. - A 180-day market exclusivity period is granted to the developer of a generic version of a product that is the first to submit an ANDA with a Paragraph IV certification[172]. Financial and Operational Risks - The company is subject to various financial risks, including market risk related to foreign currency exchange, cash flow, and interest rate risk[540]. - The company invests in highly-rated corporate bonds, commercial paper, and U.S. Treasuries, which are subject to interest rate and credit risk[541]. - Interest on the company's Note Purchase Agreement is subject to fluctuation based on SOFR, potentially impacting future expenses and cash flows[542]. - The company has significant exposure to Canadian Dollar assets and British Pound liabilities, which may expose it to material foreign currency risk[543]. Employment and Workforce - The company employed 838 people worldwide as of December 31, 2025, with 593 located in the U.S. and 245 outside the U.S.[229]. Legislative and Policy Environment - The Inflation Reduction Act of 2022 requires the U.S. Department of Health and Human Services to negotiate prices for certain high Medicare spend drugs starting in 2026, with penalties for price increases above inflation[192]. - The Affordable Care Act has imposed an annual fee on branded prescription pharmaceutical manufacturers and increased rebates payable to state Medicaid programs, impacting overall business operations[193]. - Legislative changes in the U.S. may continue to pressure prescription drug prices, impacting the pharmaceutical industry significantly[194]. International Regulations - The centralized procedure for clinical trial applications in the EU, effective January 31, 2022, streamlines the approval process across member states[208]. - Marketing authorization applications for new medicinal products in the EU require a Pediatric Investigation Plan, with specific conditions for pediatric clinical trials[212]. - Companies developing new medicinal products in the EU benefit from eight years of data exclusivity and an additional two years of market exclusivity if a new therapeutic indication is approved[211]. - The company is subject to extensive pharmacovigilance and risk management obligations under EU regulations, ensuring ongoing safety monitoring of medicinal products[213]. Legal Compliance - The federal Anti-Kickback Statute prohibits remuneration to induce purchases under federal healthcare programs, with broad interpretations that could impact business practices[196]. - Violations of the federal civil False Claims Act can result in significant penalties, including fines and exclusion from government healthcare programs[198]. - The company must comply with the FCPA and similar anti-bribery laws globally, particularly in jurisdictions with government-sponsored healthcare systems[204].

Financial Data and Key Metrics Changes - In 2025, the company achieved record net revenue of $856 million for SUBLOCADE, a 13% increase compared to 2024, and total net revenue of $1.24 billion, representing a 4% increase year-over-year [5][19] - Adjusted EBITDA grew 20% year-over-year to $428 million in 2025, with notable margin improvement [5][24] - Operating expenses are projected to not exceed $450 million in 2026 [5] Business Line Data and Key Metrics Changes - SUBLOCADE dispense volume grew 12% year-over-year in Q4 and 6% compared to Q3, with new patient starts up 25% year-over-year [12][20] - Total SUBLOCADE net revenue for Q4 was $252 million, a 30% increase year-over-year [20] - SUBOXONE Film net revenue benefited from continued generic price stability, with Q4 net revenue including a gross benefit of $23 million [21] Market Data and Key Metrics Changes - The long-acting injectables (LAIs) category saw growth approaching 18% in Q4 2025 [40][44] - The company reported stabilization of SUBLOCADE's market share in the mid-70s [13][34] Company Strategy and Development Direction - The company is executing phase II of the Indivior Action Agenda, focusing on accelerating SUBLOCADE dispense unit growth and net revenue throughout 2026 [8][28] - A new $400 million share repurchase program has been authorized to return value to shareholders [7][27] - The company aims to strategically deploy capital to create long-term value, focusing on managing debt and evaluating business development opportunities [10][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business's momentum and the potential for SUBLOCADE, emphasizing that long-acting injectables remain underutilized [9][34] - The company expects to deliver SUBLOCADE dispense unit growth in the mid-teens in 2026, an acceleration from the 7% growth achieved in 2025 [9][25] - Management is optimistic about the engagement from the direct-to-consumer campaign launched in October 2025, which has shown early indicators of success [16][17] Other Important Information - The company eliminated a significant future liability by paying the outstanding $295 million obligation related to a legacy DOJ matter [6][26] - The company ended 2025 with gross cash and investments of $222 million, with net leverage below one time [26] Q&A Session Summary Question: Thoughts on LAI buprenorphine modalities penetration and market share - Management believes there is significant opportunity for LAI penetration, currently at 9%, with potential growth to 20%-30% based on market research [33][34] Question: Guidance assumptions for LAI market growth and share in 2026 - Management expects mid-teen SUBLOCADE growth and continued stabilization of market share [41][42] Question: Medicaid funding landscape impact on SUBLOCADE - Management is optimistic about Medicaid support and believes there is substantial growth opportunity for SUBLOCADE regardless of Medicaid funding fluctuations [51][52] Question: Shape of SG&A in 2026 and DTC spending - Management indicated that DTC spending is a priority and will be maintained for a multi-year period to drive long-acting injectable penetration [51] Question: Contribution from the criminal justice system to SUBLOCADE guidance - Management sees the criminal justice segment as a strong opportunity for growth, contributing to the overall guidance for mid-teens growth [67] Question: Expectations for SUBLOCADE ex U.S. revenues - Management anticipates relatively flat year-over-year revenues for SUBLOCADE outside the U.S., with growth in some regions offset by declines in others [71]

Financial Data and Key Metrics Changes - In 2025, the company achieved record net revenue of $1.24 billion, a 4% increase compared to the previous year, with SUBLOCADE net revenue reaching $856 million, reflecting a 13% increase year-over-year [5][19] - Adjusted EBITDA grew by 20% year-over-year to $428 million, with a margin improvement of 500 basis points [5][24] - Operating expenses are projected to not exceed $450 million in 2026, indicating a focus on cost management [5][10] Business Line Data and Key Metrics Changes - SUBLOCADE dispense volume grew by 12% year-over-year in Q4 and 7% for the full year, indicating strong demand for the product [12][20] - The company launched a direct-to-consumer campaign, "Move Forward in Recovery," which has shown early signs of success, including a 60% increase in branded online search volume [16][17] Market Data and Key Metrics Changes - The long-acting injectables (LAIs) market is experiencing growth, with the company reporting a category growth of approximately 18% in Q4 2025 [40][44] - The company maintains a market share in the mid-70s for SUBLOCADE, with new patient starts achieving all-time highs [13][34] Company Strategy and Development Direction - The company is executing phase two of the Indivior Action Agenda, focusing on accelerating SUBLOCADE growth and enhancing adjusted EBITDA and cash flow [8][28] - The capital deployment strategy includes managing debt, a $400 million share repurchase program, and evaluating business development opportunities for growth drivers [10][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business's ability to accelerate growth in 2026, with expectations of mid-teens dispense unit growth for SUBLOCADE [9][41] - The company believes long-acting injectables remain underutilized, presenting significant growth opportunities [9][33] Other Important Information - The company eliminated a significant future liability by paying a $295 million obligation related to a legacy DOJ matter [6][7] - The company ended 2025 with gross cash and investments of $222 million, positioning itself well for future investments [26] Q&A Session Summary Question: Thoughts on LAI penetration and market share - Management believes there is significant opportunity for LAI penetration to grow from the current 9%, with potential analogs suggesting a range of 20%-30% [33][34] Question: Guidance assumptions for LAI market growth in 2026 - The guidance assumes mid-teen SUBLOCADE growth, with continued stabilization of market share [41][42] Question: Medicaid funding landscape impact on SUBLOCADE - Management is optimistic about Medicaid support for opioid use disorder treatments and believes growth opportunities exist regardless of funding fluctuations [51][52] Question: Shape of SG&A in 2026 and DTC spending - Management indicated that DTC spending is a priority, with a commitment to over-invest in patient education and engagement [51][53] Question: Contribution from the criminal justice system to SUBLOCADE guidance - The criminal justice segment is viewed as a strong opportunity for growth, contributing to the overall LAI category expansion [67]

Indivior, Powering Recovery, Renewing Hope. Q4 and FY 2025 Financial Results February 26, 2026 IMPORTANT CAUTIONARY STATEMENT REGARDING FORWARD- LOOKING STATEMENTS Execution Against the Indivior Action Agenda Joe Ciaffoni, CEO Forward-looking statements speak only as of the date that they are made and should be regarded solely as our current plans, estimates and beliefs. Except as required by law, we do not undertake and specifically decline any obligation to update, republish or revise forward-looking stat ...

Financial Performance - Total SUBLOCADE net revenue for FY 2025 reached $856 million, a 13% increase year-over-year, with Q4 2025 net revenue at $252 million, up 30% year-over-year[6]. - Adjusted EBITDA for FY 2025 was $428 million, representing a 20% increase from $358 million in FY 2024, with Q4 2025 adjusted EBITDA at $142 million, a 91% increase year-over-year[11]. - GAAP net income for FY 2025 was $210 million ($1.64 diluted earnings per share), compared to $7 million ($0.05 diluted earnings per share) in FY 2024[11]. - Net revenue for Q4 2025 was $358 million, a 20% increase from $298 million in Q4 2024; total revenue for 2025 reached $1,239 million, up 4% from $1,188 million in 2024[24]. - Net income for 2025 was $210 million, significantly up from $7 million in 2024, with earnings per share increasing to $1.68 from $0.05[24]. - Non-GAAP net income for Q4 2025 was $107 million, up from $47 million in Q4 2024, with the annual total at $320 million compared to $240 million in 2024[47]. - Adjusted EBITDA for Q4 2025 was $142 million, an increase from $75 million in Q4 2024, with the annual figure at $428 million compared to $358 million in 2024[52]. Revenue Guidance - Full-year 2026 financial guidance includes total net revenue projected between $1,125 million and $1,195 million, and total SUBLOCADE net revenue between $905 million and $945 million[8]. - The company reaffirmed its full-year 2026 financial guidance announced on January 8, 2026[5]. Operational Highlights - The company launched a nationwide direct-to-consumer campaign on October 1, 2025, to increase awareness of SUBLOCADE and long-acting injectables for opioid use disorder[6]. - U.S. SUBLOCADE net revenue for FY 2025 was $794 million, a 13% increase year-over-year, driven by a 7% growth in dispense unit volume[6]. - SUBLOCADE revenue for Q4 2025 was $233 million, a 29% increase from $180 million in Q4 2024; total SUBLOCADE revenue for 2025 reached $794 million, up from $704 million[33]. Expenses and Liabilities - Selling, general and administrative expenses (SG&A) for Q4 2025 were $189 million, a 8% increase from $175 million in Q4 2024; total SG&A for 2025 was $634 million, up from $612 million[24]. - Research and development expenses decreased to $21 million in Q4 2025 from $31 million in Q4 2024; total R&D expenses for 2025 were $97 million, down from $107 million[24]. - Cash and cash equivalents decreased to $195 million at the end of 2025 from $319 million at the end of 2024[27]. - Total assets decreased to $1,201 million in 2025 from $1,316 million in 2024, while total liabilities decreased to $1,300 million from $1,652 million[27]. - The company reported a net cash used in operating activities of $27 million for 2025, compared to $36 million provided in 2024[30]. Tax and Interest - The effective tax rate for 2025 YTD was 12%, significantly lower than 65% in 2024, while the non-GAAP effective tax rate was 20% compared to 27% in 2024[46]. - Interest expense for Q4 2025 was $6 million, down from $13 million in Q4 2024, with annual interest expense totaling $45 million compared to $41 million in 2024[52]. - The company reported a tax settlement of $32 million for the year, which is not expected to impact future tax rates[46]. Corporate Actions - A new $400 million share repurchase program has been authorized, with repurchases to be made opportunistically from available cash[5]. - Indivior completed the redomiciliation from the UK to the US on January 26, 2026, establishing Indivior Pharmaceuticals, Inc. as the new parent company[6]. - The company incurred litigation settlement expenses of $2 million in Q4 2025, compared to a $1 million benefit in Q4 2024, with annual expenses at $3 million versus $195 million in 2024[47]. - The company is focusing on corporate initiative transitions, which accounted for $46 million in Q4 2025 and $87 million for the year, indicating a strategic shift in operations[52].