Core Viewpoint - Indivior PLC plans to change its domicile from the U.K. to the U.S. by establishing a new parent company, Indivior Pharmaceuticals, Inc. (IPI), to leverage the benefits of its U.S. stock listing [1][2]. Group 1: Redomiciliation Process - The redomiciliation will be executed through a U.K. court-sanctioned scheme of arrangement, requiring shareholder approval [2][3]. - Upon approval, Indivior PLC will become a wholly owned subsidiary of IPI, with IPI's common stock listed on Nasdaq under the symbol INDV [2][3]. - Shareholders will receive one IPI share for each Indivior PLC share held, with Indivior PLC shares cancelled at the time of exchange [2]. Group 2: Timeline and Voting - A formal vote by Indivior PLC shareholders is necessary, requiring a majority in number and 75% in value of shares voted [3]. - Key dates include: - Mid November 2025: Issuance of shareholder circular and notice of extraordinary general meeting (EGM) - Early December 2025: EGM held in London - Late January 2026: Effective date of the scheme and trading of IPI shares on Nasdaq begins [7]. Group 3: Strategic Benefits - The change aims to expand Indivior's presence in U.S. capital markets and increase potential U.S. equity indexation [6]. - It will simplify corporate governance and reduce complexity, positioning Indivior as a U.S.-based treatment innovator [6]. - The move is expected to enhance collaboration with public health leaders on advancing SUBLOCADE® for opioid use disorder [6].

Core Insights - Indivior PLC is recognized as one of the best performing healthcare stocks, specializing in treatments for opioid use disorder (OUD) with key products SUBLOCADE and SUBOXONE [1] Financial Performance - In Q2 2025, Indivior reported total net revenue of $302 million, with SUBLOCADE sales increasing by 9% year-over-year to $209 million, driven by a 20% rise in U.S. volumes compared to Q1 2025 [2] - The company raised its full-year 2025 revenue guidance to $1.03–$1.08 billion, up from a previous range of $955 million–$1.025 billion, and adjusted EBITDA guidance increased to $275–$300 million [2] Strategic Initiatives - The results are attributed to the "Indivior Action Agenda," which focuses on expanding SUBLOCADE in the U.S. and improving operational efficiency [3] - Indivior consolidated its stock listing to Nasdaq in July 2025, reinforcing its U.S.-focused growth strategy [3] - Patrick Barry was appointed as Chief Commercial Officer in May, bringing over 30 years of pharmaceutical experience to enhance SUBLOCADE commercialization [3] Future Outlook - Indivior anticipates continued growth for SUBLOCADE through 2026 and beyond, alongside operational improvements aimed at enhancing shareholder value [4] - The company is working towards resolving litigation settlement liabilities by 2027, which is expected to improve financial flexibility [4] - Active research and development efforts are ongoing, with pipeline programs INDV-2000 and INDV-6001 targeting next-generation treatments for OUD and related conditions [4]

Core Viewpoint - Indivior PLC (NASDAQ:INDV) is positioned as a key player in the pharmaceutical industry, focusing on addiction and mental health treatments, particularly opioid addiction, which is a critical public health concern [1][5]. Group 1: Company Overview - Indivior specializes in developing medications for addiction and serious mental health disorders, with a significant emphasis on opioid addiction treatments [1][5]. - The company faces competition from other firms in the addiction treatment sector, including Alkermes and Purdue Pharma [1]. Group 2: Stock Performance and Potential - The target price for INDV is set at $34, indicating a potential growth of 42.65%, suggesting analysts see significant upside potential in the stock [2][4][5]. - Over the past month, INDV has experienced a gain of 3.77%, reflecting a positive trend, although there has been a slight decline of 0.19% in the last 10 days, which may present a buying opportunity [2][4]. Group 3: Financial Health - The Piotroski Score for INDV is 8, indicating strong financial health and solid fundamentals, making it an attractive option for value investors [3][5]. - The high Piotroski Score suggests that INDV is well-positioned financially, which is a positive indicator for potential investors [3].

Core Insights - Indivior has moved up 11 positions to the 46th spot on Barchart's Top 100 Stocks to Buy, indicating strong market interest and momentum [1] - The company has shown significant growth, with a nearly 13% increase in stock price over the past month and a remarkable 139% increase over the past 12 months [1] Financial Performance - In the first half of 2025, Indivior reported a net profit of $65 million, a 281% increase compared to a loss of $36 million in the same period the previous year [4] - On a non-GAAP basis, earnings were $121 million, down from $138 million, primarily due to previous litigation expenses [4][5] - For the full year 2025, Indivior expects top-line revenue of $1.055 billion, an increase from the previous estimate of $990 million, although down from $1.18 billion in 2024 [6] - The company anticipates adjusted EBITDA of $288 million for 2025, up from a prior estimate of $240 million [7] Product and Market Dynamics - Indivior's revenue is heavily reliant on its Sublocade product, which accounts for 70% of annual revenue, with the U.S. market contributing 93% of Sublocade revenue [8] - Despite increased competition leading to a decline in market share for its Suboxone products, Sublocade revenue is expected to rise by 3% in 2025, reaching $775 million [6]

Core Insights - The session is part of the Morgan Stanley Global Healthcare Conference, featuring key executives from Indivior, including CEO Joe Ciaffoni and CFO Ryan Preblick [2]. Group 1 - The session is introduced by Thibault Boutherin, co-head of the European Pharm Equity Research team based in London [1]. - Important disclosures related to the session can be found on the Morgan Stanley website [2]. - The format of the session includes introductory remarks followed by a Q&A segment [3].

Summary of Indivior Conference Call Company Overview - **Company**: Indivior - **Industry**: Pharmaceutical, specifically focused on treatments for opioid use disorder Key Points and Arguments Financial Performance and Guidance - Indivior is optimistic about its performance in 2025 and is focused on executing its financial guidance despite acknowledging the challenges ahead [2][4] - The company is generating significant revenue and has a strong growth driver in SUBLOCADE, which is the first long-acting injectable for opioid use disorder [11][12] - Indivior plans to reduce operational expenses significantly starting January 2026, with a focus on eliminating non-essential activities while investing heavily in SUBLOCADE [17][18][50] Indivior Action Agenda - The company is currently in phase one of its Indivior Action Agenda, aimed at generating momentum for SUBLOCADE through improved commercial execution [3][21] - Phase two, expected to start on January 1, 2026, will focus on accelerating SUBLOCADE's market penetration, particularly in the U.S. [4][21] Medicaid and Revenue Sources - Over half of Indivior's revenue comes from Medicaid, with approximately 65% of SUBLOCADE's revenue derived from this source [9][10] - The company is confident in its ability to grow SUBLOCADE within the Medicaid framework, especially given recent legislative support for opioid use disorder treatments [9][10] Market Position and Competition - SUBLOCADE is the number one prescribed long-acting injectable and has been used in over 350,000 patients, with 88% coverage in Medicare and Medicaid [22][23] - Indivior acknowledges competition from products like Brixadi but remains confident in SUBLOCADE's market position and its unique attributes [23][24] Long-Acting Injectable Market - Current penetration of long-acting injectables in the buprenorphine market is around 8%, with aspirations to increase this significantly through education and marketing efforts [25][27] - The company recognizes various barriers to increasing penetration, including patient preferences and physician inertia, and is focused on addressing these challenges [28][29] Strategic Focus and Future Plans - Indivior is committed to enhancing its commercial execution and is exploring options for its international operations, which currently contribute 15% of sales [19][20] - The company is also evaluating its pipeline, with two Phase 2 assets under consideration for potential advancement to Phase 3 [42][44] Capital Allocation and Shareholder Value - Indivior plans to reassess its capital allocation priorities in early 2026, focusing on executing its current operational strategies before considering M&A or returning cash to shareholders [46][48] - The CEO believes there is a significant gap between the intrinsic value of the company and its current stock price, attributing this to market misunderstandings regarding SUBLOCADE's growth potential and the company's cost structure [49][50] Additional Important Insights - Indivior's workforce is highly motivated, with over 85% of employees personally impacted by substance use disorder, contributing to the company's resilience [12] - The company is actively working to improve its organizational complexity and streamline operations to better focus on its core products [14][15] This summary encapsulates the key insights from the Indivior conference call, highlighting the company's strategic direction, market positioning, and financial outlook.

Company Participation in Investor Events - Indivior PLC will participate in the Morgan Stanley 23rd Annual Global Healthcare Conference on September 8th, where CEO Joe Ciaffoni and CFO Ryan Preblick will host meetings and a fireside discussion [1] - The company will also attend the H.C. Wainwright 27th Annual Global Investment Conference on September 9th, with similar meeting arrangements [2] Company Overview - Indivior is a global pharmaceutical company focused on developing medicines for opioid use disorder (OUD), aiming to transform OUD into a recognized chronic disease [3] - The company is headquartered in Richmond, VA, employs over 1,000 individuals globally, and its products are available in over 30 countries [3]

Core Insights - Indivior PLC has established itself as a leader in long-acting injectable treatments for opioid use disorder, showcasing significant growth in its product SUBLOCADE [1] - The company's Q2 2025 results indicate strong performance, characterized by increasing cash flows and a strategic focus on a three-phase development plan [1] Company Performance - The Q2 2025 results highlight robust growth in SUBLOCADE, which is a key product for the company [1] - There is a notable increase in cash flows, suggesting improved financial health and operational efficiency [1] Industry Position - Indivior PLC is positioned as a science-based expert in the treatment of opioid use disorder, indicating a strong competitive advantage in the healthcare sector [1]

Core Viewpoint - Indivior PLC (INDV) has been upgraded to a Zacks Rank 1 (Strong Buy), indicating a positive earnings outlook that may lead to increased stock price [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in earnings estimates, which are a significant factor influencing stock prices [4][6]. - Rising earnings estimates for Indivior suggest an improvement in the company's underlying business, likely resulting in upward pressure on its stock price [5][10]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [7]. - Only the top 5% of Zacks-covered stocks receive a "Strong Buy" rating, indicating superior earnings estimate revisions [9][10]. Recent Earnings Estimate Revisions - Indivior is expected to earn $1.45 per share for the fiscal year ending December 2025, with no year-over-year change [8]. - Over the past three months, the Zacks Consensus Estimate for Indivior has increased by 22.9%, reflecting positive sentiment among analysts [8].

[PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Unaudited Financial Statements](index=3&type=section&id=Item%201.%20Unaudited%20Financial%20Statements.) This section presents the unaudited condensed consolidated financial statements for Q2 2025 and 2024, showing a shift to a net income of **$18 million** in Q2 2025 from a **$97 million** net loss in Q2 2024 due to the absence of a prior-year litigation settlement expense Condensed Consolidated Statements of Operations Highlights (in millions) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | **Net revenue** | $302 | $299 | $568 | $583 | | **Gross profit** | $250 | $220 | $472 | $466 | | **Operating income (loss)** | $72 | $(118) | $138 | $(43) | | **Net income (loss)** | $18 | $(97) | $65 | $(36) | | **Diluted earnings (loss) per share** | $0.14 | $(0.72) | $0.52 | $(0.27) | Condensed Consolidated Balance Sheets Highlights (in millions) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total current assets** | $951 | $827 | | **Total assets** | $1,452 | $1,316 | | **Total current liabilities** | $1,056 | $924 | | **Total liabilities** | $1,709 | $1,652 | | **Total shareholders' deficit** | $(257) | $(337) | Condensed Consolidated Statements of Cash Flows Highlights (in millions) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | **Net cash provided by operating activities** | $233 | $51 | | **Net cash (used in) provided by investing activities** | $(22) | $26 | | **Net cash used in financing activities** | $(22) | $(91) | [Note 2: Segment, Geographic and Other Revenue Information](index=12&type=section&id=Note%202.%20Segment,%20Geographic%20and%20Other%20Revenue%20Information) The company operates as a single segment, with Q2 2025 net revenue increasing **1%** to **$302 million**, driven by a **9%** rise in U.S. SUBLOCADE sales Net Revenue by Product and Geography (in millions) | Product/Region | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | **U.S. SUBLOCADE** | $195 | $179 | $359 | $346 | | **U.S. Sublingual & other** | $52 | $63 | $107 | $126 | | **U.S. PERSERIS** | $8 | $13 | $12 | $23 | | **Total U.S.** | $256 | $255 | $478 | $496 | | **Rest of World** | $46 | $44 | $90 | $87 | | **Total Net Revenue** | $302 | $299 | $568 | $583 | - The company operates in a single operating and reportable segment, with the CEO identified as the chief operating decision maker (CODM)[36](index=36&type=chunk) [Note 3: Income Tax](index=13&type=section&id=Note%203.%20Income%20Tax) The effective tax rate for Q2 2025 was **71%**, significantly higher than the U.K. statutory rate, primarily due to a **$33 million** tax reserve for a U.K. HMRC settlement Effective Tax Rate | Period | 2025 | 2024 | | :--- | :--- | :--- | | **Three Months Ended June 30** | 71% | 19% | | **Six Months Ended June 30** | 46% | 25% | - A tax reserve of **$33 million** was recorded in Q2 2025 for a settlement with U.K. HMRC related to a finance structure in place from 2019 through May 2024[48](index=48&type=chunk) - The company is evaluating the implications of the new U.S. tax legislation, the 'One Big Beautiful Bill Act', but does not currently anticipate significant impacts[35](index=35&type=chunk) [Note 12: Commitments and Contingencies](index=18&type=section&id=Note%2012.%20Commitments%20and%20Contingencies) The company faces significant legal proceedings, including civil opioid litigation with a **$79 million** provision, and dental injury lawsuits with over **21,000** plaintiffs where loss cannot be estimated - A provision of **$79 million** has been recorded for a settlement in the civil opioid litigation, expected to be finalized in or before November 2025, pending sufficient participation from states and subdivisions[85](index=85&type=chunk)[60](index=60&type=chunk) - The company is a defendant in multi-district litigation (MDL) involving **1,877 cases** and **21,402 plaintiffs** alleging SUBOXONE Film caused dental injuries, but cannot estimate possible loss at this stage[88](index=88&type=chunk)[93](index=93&type=chunk) - A multiparty shareholder claim remains pending in the U.K. alleging false or misleading statements related to the product switch from SUBOXONE Tablets to SUBOXONE Film[94](index=94&type=chunk) [Note 13: Revision of Previously Issued Financial Statements](index=21&type=section&id=Note%2013.%20Revision%20of%20Previously%20Issued%20Financial%20Statements) The company revised its 2022-2024 financial statements to correct an error in the U.S. Branded Fee accrual, increasing FY 2024 net income from **$2 million** to **$7 million** - An error was identified in the methodology used to accrue for the annual U.S. fee on drug manufacturers (the 'Branded Fee'), resulting in an overstatement in prior periods[99](index=99&type=chunk) Impact of Revision on FY 2024 Consolidated Statement of Operations (in millions) | Metric | As Reported | Adjustment | Revised | | :--- | :--- | :--- | :--- | | **Operating income** | $32 | $6 | $38 | | **Net income** | $2 | $5 | $7 | | **Diluted EPS** | $0.02 | $0.03 | $0.05 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) Management discusses a **1%** Q2 2025 net revenue increase to **$302 million**, driven by SUBLOCADE's **9%** growth, improved gross margin to **83%**, and a strengthened cash position of **$510 million** [Operating Results](index=26&type=section&id=MD%26A%20Operating%20Results) Q2 2025 net revenue increased **1%** to **$302 million**, driven by a **9%** rise in U.S. SUBLOCADE revenue, while gross margin improved to **83%** due to lower discontinuation costs Net Revenue by Product (in millions) | Product | Three Months Ended June 30, 2025 | % Change YoY | | :--- | :--- | :--- | | **SUBLOCADE (Total)** | $209 | 9% | | **U.S. Film/other** | $52 | (18)% | | **PERSERIS** | $8 | (37)% | - SUBLOCADE accounted for **69%** of net revenue for the three months ended June 30, 2025, up from **64%** in the same period in 2024[114](index=114&type=chunk) - Gross margin increased to **83%** in Q2 2025 from **74%** in Q2 2024, reflecting **$41 million** in costs in the 2024 period related to the discontinuation of marketing and promotion of PERSERIS[125](index=125&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=MD%26A%20Liquidity%20and%20Capital%20Resources) Cash and cash equivalents reached **$510 million** as of June 30, 2025, with net cash from operating activities increasing to **$233 million** in H1 2025, partly due to **$120 million** in government rebate payments Financial Position (in millions) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Cash and cash equivalents** | $510 | $319 | | **Total cash and investments** | $538 | $347 | | **Total Borrowings (Short & Long-term)** | $326 | $333 | - Net cash from operating activities increased by **$182 million** in H1 2025 compared to H1 2024, benefiting from the timing of receipt and processing of approximately **$120 million** in government rebate invoices[137](index=137&type=chunk) - The company anticipates capital expenditures of **$50 million to $70 million** for the full year 2025, primarily for the SUBLOCADE suite at the Raleigh Manufacturing Facility[141](index=141&type=chunk) [Regulatory Uncertainties](index=29&type=section&id=MD%26A%20Regulatory%20Uncertainties) The company is monitoring the 'One Big Beautiful Bill Act' (OBBBA), enacted in July 2025, which could impact Medicaid funding and eligibility rules, with most provisions effective in 2027-2028 - The OBBBA, signed into law in July 2025, could impact the business through changes to Medicaid funding, eligibility rules, and state formularies[133](index=133&type=chunk) - Most of the OBBBA provisions have effective dates in 2027 and 2028, and additional federal and state guidance is expected for implementation[134](index=134&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) No material changes in market risk have occurred since the information provided in the Company's Annual Report on Form 10-K - No material changes in market risk have occurred from the information provided in the Company's Annual Report on Form 10-K[152](index=152&type=chunk) [Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - The Chief Executive Officer and Chief Financial Officer concluded that Indivior PLC's disclosure controls and procedures were effective as of June 30, 2025[153](index=153&type=chunk) - No changes occurred during the quarter ended June 30, 2025, that have materially affected, or are likely to materially affect, the Company's internal control over financial reporting[154](index=154&type=chunk) [PART II - OTHER INFORMATION](index=34&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings.) This section incorporates by reference the detailed descriptions of the company's litigation and regulatory matters from Note 12 of the financial statements - The descriptions of litigation and regulatory matters are incorporated by reference from Note 12, 'Commitments and Contingencies'[156](index=156&type=chunk) [Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors.) The company has omitted the risk factor concerning multi-exchange share listings due to its recent delisting from the London Stock Exchange to trade exclusively on Nasdaq - The company has omitted the risk factor related to its ordinary shares being listed on more than one stock exchange[157](index=157&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=34&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) During Q2 2025, the company repurchased **15,047 shares** at varying average prices, primarily to cover withholding taxes on employee equity awards, not as part of a public plan Share Repurchases for Q2 2025 | Period | Total Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | April 2025 | 2,484 | $9.53 | | May 2025 | 2,669 | $12.41 | | June 2025 | 9,894 | $13.86 | - The repurchased shares reflect shares netted to pay applicable withholding taxes on the release of awards under the 2020 LTIP, 2022 LTIP, and 2023 DBP[158](index=158&type=chunk) [Other Information](index=34&type=section&id=Item%205.%20Other%20Information.) Key updates include Indivior no longer qualifying as a 'foreign private issuer' from January 1, 2026, and the termination of a supply agreement with Curia Massachusetts effective January 31, 2026, for manufacturing consolidation - As of June 30, 2025, Indivior determined it no longer qualifies as a 'foreign private issuer' and will become subject to SEC rules for U.S. domestic issuers starting January 1, 2026[161](index=161&type=chunk) - On July 31, 2025, Indivior provided notice to terminate its Master Development and Supply Agreement with Curia Massachusetts, Inc., effective January 31, 2026, as part of a plan to consolidate manufacturing locations[162](index=162&type=chunk) [Exhibits](index=36&type=section&id=Item%206.%20Exhibits.) This section lists exhibits filed with the Form 10-Q, including amended Articles of Association, various agreements, and CEO/CFO certifications required by Sarbanes-Oxley Act