Company Performance - Indivior PLC reported quarterly earnings of $0.51 per share, exceeding the Zacks Consensus Estimate of $0.26 per share, and up from $0.44 per share a year ago, representing an earnings surprise of +96.15% [1] - The company posted revenues of $302 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 22.05%, compared to revenues of $299 million in the same quarter last year [2] - Over the last four quarters, Indivior has surpassed consensus EPS estimates three times and topped consensus revenue estimates four times [2] Stock Performance - Indivior shares have increased approximately 40% since the beginning of the year, significantly outperforming the S&P 500's gain of 8.2% [3] - The current consensus EPS estimate for the upcoming quarter is $0.26 on revenues of $253.66 million, and for the current fiscal year, it is $1.21 on revenues of $1.02 billion [7] Industry Outlook - The Medical - Drugs industry, to which Indivior belongs, is currently ranked in the top 37% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5]

Financial Data and Key Metrics Changes - Total net revenue for Q2 2025 was $300 million, an increase of 1% year-over-year, driven by record SUBLOCADE net revenue which offset pricing pressure on SUBOXONE Film [28][29] - Total SUBLOCADE net revenue reached $209 million, a 9% increase compared to Q2 2024 and a 19% increase sequentially [29] - Adjusted EBITDA for Q2 was $88 million, slightly down from the previous year due to increased marketing expenses [31] - The company raised its full-year 2025 net revenue guidance to a range of $1.03 billion to $1.08 billion, reflecting solid performance [33][34] Business Line Data and Key Metrics Changes - SUBLOCADE's dispense growth was 6% year-over-year and 9% sequentially, with market share in the U.S. remaining stable at approximately 75% [21] - The number of active SUBLOCADE prescribers increased by 14% year-over-year, indicating a solid base for future growth [22] - SUBOXONE Film outperformed expectations with a market share of 14% and benefited from stable pricing [29][30] Market Data and Key Metrics Changes - The company noted that the commercial channel represents a significant opportunity, with only 25% of SUBLOCADE volume coming from commercial patients despite 60% of covered lives being commercial [44][81] - Payer response to new dosing approaches for SUBLOCADE has been positive, with coverage reaching approximately 80% of covered lives [24] Company Strategy and Development Direction - The Indivior Action Agenda is a three-phased operational roadmap aimed at maximizing business potential and creating shareholder value, with Phase One focused on generating momentum for SUBLOCADE [10][12] - The company plans to simplify operations by eliminating non-essential activities and restructuring its R&D and medical affairs organizations [12][17] - Future phases aim to accelerate growth and profitability, with a focus on commercial stage acquisitions starting in 2026 [15][16] Management's Comments on Operating Environment and Future Outlook - Management expressed encouragement about the performance in the first half of 2025 but acknowledged the need for improvement in U.S. commercial execution [8][16] - The opioid crisis remains a significant focus, with management advocating for broader access to treatments for opioid use disorder [76][78] - The company is optimistic about the potential for SUBLOCADE, citing low long-acting injectable penetration rates as an opportunity for growth [42][78] Other Important Information - Indivior canceled its secondary listing on the London Stock Exchange to reduce costs and complexity [35] - The company was added to the U.S. Russell Indexes, enhancing its visibility among U.S. investors [35] Q&A Session Summary Question: Opportunity in commercially covered patients vs. Medicaid - Management emphasized the importance of both channels, noting that while Medicaid is crucial, there is significant potential in the commercial space where only 25% of SUBLOCADE volume currently comes from [39][44] Question: Criminal justice system channel strategy - Management acknowledged the criminal justice system as an opportunity and noted stability after previous challenges, indicating a focus on growth in this area [42] Question: Future R&D spending priorities - Management plans to reorganize R&D to maintain capabilities while focusing on essential programs, with a goal to transition successful programs into Phase 3 [41] Question: Price compression on Suboxone and SUBLOCADE growth expectations - Management has not seen signs of additional price erosion for Suboxone and expects demand-driven growth for SUBLOCADE in the second half of the year [50][52] Question: Cost savings from streamlining the business - Management indicated that significant reductions in the overall cost structure are expected, with a full-year effect anticipated in 2026 [56][57] Question: Long-term market share expectations for SUBLOCADE - Management expressed confidence in SUBLOCADE's market position and noted stabilization in market share, with a focus on increasing long-acting injectable penetration [58][59] Question: Aligning SG&A spend with industry peers - Management is assessing the organization to reduce complexity and high costs, with a focus on essential spending [66][67]

Financial Data and Key Metrics Changes - Total net revenue for the second quarter was $300 million, an increase of 1% year-over-year, driven by record SUBLOCADE net revenue which offset pricing pressure on SUBOXONE Film [29][30] - Total SUBLOCADE net revenue reached $209 million, a 9% increase compared to Q2 2024, and a 19% increase sequentially, reflecting a 9% increase in dispense volume [30] - Adjusted EBITDA for the quarter was $88 million, slightly down from the previous year due to increased marketing expenses [32] Business Line Data and Key Metrics Changes - SUBLOCADE's dispense growth was 6% year-over-year and 9% sequentially, with market share in the U.S. remaining stable at approximately 75% [21] - The number of active SUBLOCADE prescribers increased by 14% year-over-year, indicating a solid base for future growth [22] - SUBOXONE Film net revenue benefited from price stability and a modestly higher market share of 14% [30] Market Data and Key Metrics Changes - The commercial channel represents a significant opportunity, with 60% of covered lives being commercial patients, yet only 25% of SUBLOCADE volume coming from this segment [47][80] - The opioid crisis continues to drive demand, with LAI penetration currently at just under 8%, indicating substantial growth potential [44][76] Company Strategy and Development Direction - The Indivior Action Agenda is a three-phased operational roadmap aimed at maximizing business potential and improving execution, with Phase One focused on generating momentum for SUBLOCADE [10][11] - The company plans to simplify operations by eliminating non-essential activities and restructuring its R&D and medical affairs organizations [12][66] - Future phases aim to accelerate profitability and cash flow generation, with a focus on commercial stage acquisitions [15][16] Management's Comments on Operating Environment and Future Outlook - Management expressed encouragement about the performance in the first half of 2025 but acknowledged the need for improvement in U.S. commercial execution [8][39] - The company raised its full-year 2025 net revenue guidance to a range of $1.03 billion to $1.08 billion, reflecting solid year-to-date performance [35] - Management emphasized the importance of operational execution to generate momentum and achieve growth targets in 2026 [17][76] Other Important Information - Indivior canceled its secondary listing on the London Stock Exchange to reduce costs and complexity [36] - The company was added to the U.S. Russell Indexes, enhancing its visibility among U.S. investors [36] Q&A Session Summary Question: Opportunity in commercially covered patients vs. Medicaid - Management acknowledged the importance of both channels, emphasizing the need to capitalize on the commercial opportunity while maintaining focus on Medicaid [40][47] Question: Criminal justice system channel strategy - Management views the criminal justice system as a growth opportunity and plans to focus on it moving forward [44] Question: R&D spending priorities - Management indicated a significant reorganization of R&D is underway, focusing on maintaining capabilities for future programs while prioritizing essential activities [43] Question: Price compression on Suboxone - Management has not seen signs of additional price erosion for Suboxone but is factoring it into guidance [50][52] Question: Cost savings from streamlining the business - Management is focused on significant reductions in the overall cost structure, with expectations for benefits to be realized in 2026 [54][56] Question: Long-term market share expectations for SUBLOCADE - Management is optimistic about SUBLOCADE's market position and believes it will stabilize in the mid-70s percentage range [58]

Q2 2025 Performance - Total net revenue increased by 1% to $302 million compared to $299 million in Q2 2024[13, 33] - SUBLOCADE net revenue grew by 9% to $209 million compared to $192 million in Q2 2024[13, 33] - Adjusted EBITDA decreased by 5% to $88 million compared to $93 million in Q2 2024[13, 33] - Gross profit increased by 14% to $250 million, with a gross margin of 83%, a 900 bps increase from 74% in Q2 2024[33] SUBLOCADE Performance - SUBLOCADE dispense growth increased by 6% year-over-year and 9% quarter-over-quarter, reaching 165,700 in Q2 2025[24] - The prescriber base for SUBLOCADE grew by 14% year-over-year, reaching 8,284 prescribers in Q2 2025[24] - The number of healthcare professionals (HCPs) with 5+ SUBLOCADE patients increased by 9% year-over-year[25] - Total SUBLOCADE patients increased by 7% year-over-year, reaching 171,519 in Q2 2025[25] Financial Guidance - The company raised its full-year 2025 total net revenue guidance to $1030 million - $1080 million from the previous guidance of $955 million - $1025 million[14, 39] - The company raised its full-year 2025 Adjusted EBITDA guidance to $275 million - $300 million, a 20% increase at the mid-points, from the previous guidance of $220 million - $260 million[39]

[Q2 2025 Performance and FY 2025 Outlook](index=1&type=section&id=Indivior%20Reports%20Second%20Quarter%202025%20Financial%20Results%20and%20Raises%20FY%202025%20Financial%20Guidance) [Q2 2025 Business Highlights](index=1&type=section&id=Business%20Highlights) Indivior reported strong Q2 2025 results, driven by **SUBLOCADE® revenue growth** and key strategic initiatives SUBLOCADE® Q2 2025 Net Revenue Performance | Metric | Q2 2025 | Change (YoY) | Change (vs Q1'25) | | :--- | :--- | :--- | :--- | | **Total SUBLOCADE® NR** | $209m | +9% | +19% | | **U.S. SUBLOCADE® NR** | $195m | +9% | +20% | - Initiated the 'Indivior Action Agenda' focusing on U.S. SUBLOCADE growth and reducing organizational complexity to support long-term growth and cash generation[2](index=2&type=chunk)[3](index=3&type=chunk) - Completed the cancellation of its London Stock Exchange (LSE) listing to trade exclusively on Nasdaq, aligning with its focus on U.S. SUBLOCADE growth[3](index=3&type=chunk) - Introduced Adjusted EBITDA as a new key profitability measure, replacing Non-GAAP Operating Income, to better reflect operating results and cash generation[4](index=4&type=chunk)[12](index=12&type=chunk) [Revised FY 2025 Financial Guidance](index=2&type=section&id=Raising%20Financial%20Guidance%20for%202025) Indivior raised its FY 2025 guidance for **revenue** and **Adjusted EBITDA**, reflecting strong performance and stabilized SUBOXONE® Film pricing FY 2025 Guidance Revision | Metric | Prior Guidance (Mid-point) | Revised Guidance (Mid-point) | Change (Mid-point) | | :--- | :--- | :--- | :--- | | **Net Revenue (NR)** | $990m | $1,055m | +$65m | | **SUBLOCADE® NR** | $745m | $775m | +$30m | | **Adjusted EBITDA** | $240m | $287.5m | +$47.5m | - The outlook for SUBOXONE® Film has improved from an 'accelerating NR decline' to a 'more moderated NR decline' due to pricing stabilization in the U.S. generic market[5](index=5&type=chunk) [Q2 2025 Detailed Financial Results](index=2&type=section&id=Financial%20Results%20for%20Second%20Quarter%20Ended%20June%2030%2C%202025) Q2 2025 total net revenue grew to **$302 million**, with **net income** improving to **$18 million** and **cash** reaching **$538 million** Q2 2025 Financial Summary vs. Q2 2024 | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | **Total Net Revenue** | $302m | $299m | | **U.S. Net Revenue** | $256m | $255m | | **Gross Margin** | 83% | 74% | | **Net Income (Loss)** | $18m | $(97)m | | **Diluted EPS (Loss)** | $0.14 | $(0.72) | | **Adjusted EBITDA** | $88m | $93m | - The slight increase in U.S. net revenue was driven by SUBLOCADE volume growth, which offset the decline in SUBOXONE Film and the discontinuation of PERSERIS[8](index=8&type=chunk) - R&D expense decreased by **20%** to **$21 million**, reflecting a refocusing of the pipeline on existing Phase 2 OUD assets[8](index=8&type=chunk) - Cash and investments totaled **$538 million** at quarter-end, an increase of **$191 million** from the end of 2024[8](index=8&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20consolidated%20statements%20of%20operations) Indivior reported Q2 2025 **net income** of **$18 million**, a significant improvement from Q2 2024's **net loss** Condensed Consolidated Statements of Operations (Unaudited, in millions) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | **Net revenue** | $302 | $299 | $568 | $583 | | Gross profit | $250 | $220 | $472 | $466 | | Litigation settlement | $— | $160 | $1 | $160 | | **Operating income (loss)** | **$72** | **$(118)** | **$138** | **$(43)** | | Income (loss) before income taxes | $62 | $(121) | $121 | $(48) | | **Net income (loss)** | **$18** | **$(97)** | **$65** | **$(36)** | | **Diluted EPS (loss)** | **$0.14** | **$(0.72)** | **$0.52** | **$(0.27)** | [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20consolidated%20balance%20sheets) Total assets reached **$1.45 billion** as of June 30, 2025, with **cash and equivalents** increasing to **$510 million** Condensed Consolidated Balance Sheets (Unaudited, in millions) | | 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)** | | **Cash and cash equivalents** | $510 | $319 | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20consolidated%20statements%20of%20cash%20flows) Net cash from operating activities significantly improved to **$233 million** for H1 2025, resulting in a **$510 million** cash balance Condensed Consolidated Statements of Cash Flows (Unaudited, in millions) | Six Months Ended June 30, | 2025 | 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) | | **Net increase (decrease) in cash and cash equivalents** | **$189** | **$(14)** | | Cash and cash equivalents at end of period | $510 | $302 | [Reconciliation of GAAP to Non-GAAP Measures](index=9&type=section&id=Reconciliation%20of%20GAAP%20to%20non-GAAP%20financial%20information) [Selected Revenue and Expense Information](index=9&type=section&id=Selected%20revenue%20and%20expense%20information) Q2 2025 revenue breakdown highlights **U.S. SUBLOCADE® revenue** at **$195 million** and increased selling and marketing expenses Net Revenue by Product/Region (in millions) | | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | **US SUBLOCADE*** | $195 | $179 | | **US Sublingual & other** | $52 | $63 | | **Total U.S.** | $256 | $255 | | **Rest of World** | $46 | $44 | | **Total Net Revenue** | **$302** | **$299** | [Reconciliation of GAAP to Non-GAAP Financial Information](index=9&type=section&id=Reconciliation%20of%20GAAP%20to%20non-GAAP%20financial%20information_details) Q2 2025 non-GAAP net income was **$64 million** (vs GAAP **$18 million**), adjusted for share-based compensation and other costs Q2 2025 GAAP to Non-GAAP Net Income Reconciliation (in millions) | | Amount | | :--- | :--- | | **GAAP net income** | **$18** | | Adjustments in cost of sales | $2 | | Adjustments in SG&A | $12 | | Adjustments in interest expense | $4 | | Adjustments in tax expenses | $28 | | **Non-GAAP net income** | **$64** | - Non-GAAP diluted EPS for Q2 2025 was **$0.51**, compared to **$0.48** in Q2 2024[39](index=39&type=chunk) [Adjusted EBITDA Reconciliation](index=11&type=section&id=Adjusted%20EBITDA) Indivior adopted Adjusted EBITDA as a key non-GAAP measure, reporting **$88 million** for Q2 2025 reconciled from GAAP net income Q2 2025 Net Income to Adjusted EBITDA Reconciliation (in millions) | | Amount | | :--- | :--- | | **Net income** | **$18** | | Interest (income) | $(6) | | Interest expense | $15 | | Income tax expense | $44 | | Depreciation and amortization | $3 | | Share-based compensation expense | $8 | | Manufacturing transition | $2 | | Corporate initiative transition | $4 | | **Adjusted EBITDA** | **$88** | - The company provided supplemental historical Adjusted EBITDA, showing **$93 million** for Q2 2024 and **$358 million** for the full year 2024[44](index=44&type=chunk)

Core Insights - Indivior PLC reported strong financial results for Q2 2025, driven by net revenue growth from SUBLOCADE and pricing stability in SUBOXONE Film, prompting an increase in financial guidance for the year [2][4][6] Financial Performance - Total net revenue for Q2 2025 was $302 million, a 1% increase from $299 million in Q2 2024 [8][20] - SUBLOCADE net revenue reached $209 million, up 9% year-over-year and 19% compared to Q1 2025 [6][8] - U.S. SUBLOCADE net revenue was $195 million, reflecting a 9% increase from Q2 2024 and a 20% increase from Q1 2025 [7][8] - Non-GAAP gross margin for Q2 was 84%, unchanged from Q2 2024 [16] Revised Financial Guidance - The company raised its 2025 financial guidance, with total net revenue now expected to be between $1,030 million and $1,080 million, up from the previous range of $955 million to $1,025 million [4][6] - Adjusted EBITDA guidance was increased to a range of $275 million to $300 million, up from $220 million to $260 million [4][6] Strategic Initiatives - The Indivior Action Agenda is being implemented to enhance operational momentum, focusing on U.S. SUBLOCADE growth and organizational simplification [2][6] - The company has strengthened its executive team and board with new appointments to support its strategic goals [7] Market Position and Developments - Indivior has been included in the Russell 2000® Index and Russell 3000® Index, enhancing its market visibility [7] - New data presented at scientific meetings indicate that higher doses of SUBLOCADE may improve outcomes for patients with high fentanyl use [7]

Group 1 - Indivior PLC has announced the cancellation of its secondary listing on the London Stock Exchange effective July 25, 2025, while maintaining its primary listing on the Nasdaq Stock Market [1] - An FAQ document has been prepared for shareholders regarding the London Delisting, which is accessible on the company's website [2] - 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][4] Group 2 - The company has a pipeline of product candidates to expand its portfolio of OUD treatments and operates in over 30 countries worldwide [4] - Indivior is headquartered in Richmond, Virginia, and employs over 1,000 individuals globally [4]

Revenue Performance - Net revenue for the three months ended March 31, 2025, decreased by $18 million, or 6%, to $266 million compared to $284 million in the prior year period[97] - U.S. net revenue decreased by 8% to $222 million in Q1 2025 from $241 million in Q1 2024, primarily due to increased competition and lower pricing for SUBOXONE Film[98] - SUBLOCADE accounted for 66% of net revenue in Q1 2025, down from 63% in Q1 2024, while other buprenorphine-based products accounted for 32% in Q1 2025, down from 33% in Q1 2024[93] Financial Metrics - Gross margin decreased to 83% in Q1 2025 from 87% in Q1 2024, reflecting unfavorable manufacturing variances in the current period[103] - Net cash provided by operating activities was $75 million in Q1 2025, an increase of $112 million compared to a net cash used of $37 million in Q1 2024[111] - Total cash and investments increased to $400 million as of March 31, 2025, from $347 million as of December 31, 2024[109] Expenses and Investments - Research and development expenses decreased by $5 million, or 19%, to $22 million in Q1 2025, as the company refocused its development pipeline[105] - The company expects capital expenditures of approximately $50 million to $70 million in 2025, primarily for the SUBLOCADE suite at the Raleigh Manufacturing Facility[113] - Capital expenditures for the three months ended March 31, 2025, were $5 million, primarily for the expansion of the Raleigh Manufacturing Facility[118] Liabilities and Cash Needs - Current liabilities exceed current assets by $122 million, and total liabilities exceed total assets by $285 million[115] - The company anticipates meeting its cash needs for at least the next twelve months through existing cash, operations, and debt[116] - The company has a focus on litigation settlement payments and debt repayments as part of its cash requirements[119] Regulatory and Development Updates - The FDA approved label changes for SUBLOCADE on February 24, 2025, allowing for a rapid initiation protocol and alternative injection sites[94] - The INDV-2000 Phase 2 proof of concept study's last subject visit is now expected in the first half of 2026, delayed from late 2025 due to lower than expected enrollment[121] Contingent Liabilities and Market Risk - The company is subject to contingent liabilities as described in its financial statements[117] - No material changes in market risk have occurred since the last annual report[124] - As of March 31, 2025, no material changes to contractual obligations have occurred beyond the ordinary course of business[119] Sales Volume and Liquidity - The company needs to sustain sales volume performance to maintain necessary liquidity in the near term[116] - The company is investing in capital expenditures to support its manufacturing capabilities[118]

Financial Data and Key Metrics Changes - Total net revenue in Q1 2025 declined by 6% year on year, amounting to $266 million, primarily due to intensified competition from generic film providers and the discontinuation of PERSERIS [6][16] - Non-GAAP adjusted operating profit increased by 10% compared to the previous year, reflecting lower expenses that partially offset the reduction in total net revenue [11] - Non-GAAP adjusted net income decreased by 11% year on year to $51 million, influenced by revenue dynamics and increased net finance expenses [25] Business Line Data and Key Metrics Changes - SUBLOCADE revenue declined by 2% year on year, with U.S. performance impacted by funding challenges in the justice system, although there was growth in the organized health system channel [7][18] - SUBLOCADE's net revenue outside the U.S. grew by 8% to $13 million, indicating strong performance in international markets [18] - Suboxone Film's average market share in the U.S. was approximately 15%, down by three percentage points from the previous year, reflecting ongoing pricing pressures [21] Market Data and Key Metrics Changes - U.S. net revenue declined by 8% year on year, while the rest of the world saw a 3% increase in reported revenue [16][17] - Approximately 170,700 patients were treated in the U.S. over the past twelve months, representing a 14% increase year on year [9] Company Strategy and Development Direction - The company is focused on reinvesting approximately $50 million of gross savings into SUBLOCADE and its pipeline, while maintaining financial flexibility and disciplined capital allocation [12][28] - Management anticipates that SUBLOCADE's net revenue performance will improve in the second half of the year due to commercial investments and label updates [10][19] - The company is actively monitoring the evolving funding landscape in the justice system, with expectations for growth as new systems are added and funding challenges are addressed [56][60] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in delivering full-year 2025 guidance, despite current challenges, and noted that the opioid epidemic remains a bipartisan issue with strong governmental support [35][29] - The company expects to see stabilization in the competitive landscape for SUBLOCADE, with new patient share remaining stable at over 70% [10][45] - Management highlighted the importance of generating real-world evidence to support the use of OpV and the potential for growth in the long-acting injectable category [84][86] Other Important Information - The company ended Q1 with gross cash and investments of $400 million, higher than expected due to a decrease in net working capital [27] - The court granted the company's motion to dismiss U.S. shareholder claims, with a 30-day period for plaintiffs to amend their complaint [29] Q&A Session Summary Question: Any proposals regarding Medicaid funding that might change the outlook? - Management is closely monitoring the situation, noting that it remains a bipartisan issue with strong governmental support for opioid treatment [35] Question: When will SUBLOCADE return to growth? - Management expects growth to accelerate in the organized health system channel through marketing initiatives and label enhancements [44] Question: Expectations for CGS dynamics and funding improvements? - Management anticipates growth in criminal justice accounts through the year, with potential funding improvements from various interventions [56][60] Question: Impact of pricing and destocking for SUBLOCADE in Q1? - There was some destocking in Q1, but overall pricing remained stable [63] Question: Expectations around the marketing campaign and new label? - Management sees significant opportunity for awareness and growth in the long-acting injectable category, with early indicators showing positive impact from marketing efforts [68] Question: Further pricing pressure for Suboxone? - Management expects continued price erosion due to competitive pressures, particularly with the introduction of additional generics [76][78] Question: Progress on alternate sites of care for SUBLOCADE? - The company has made progress with eight partners and is working to expand access to alternate sites of care [105]

[Indivior Q1 2025 Earnings Release](index=1&type=section&id=Indivior%20Q1%202025%20Earnings%20Release) The company reports Q1 2025 results, strategic updates, and reaffirms full-year guidance amid market challenges and pipeline developments [Financial & Operational Highlights](index=1&type=section&id=Financial%20%26%20Operational%20Highlights) Q1 2025 net revenue declined 6% to $266 million due to generic competition and temporary SUBLOCADE headwinds **Q1 2025 Financial Summary (vs. Q1 2024)** | Unaudited, $m | Q1 2025 | Q1 2024 | % Change | | :--- | :--- | :--- | :--- | | **Net Revenue** | 266 | 284 | (6)% | | **Operating Income** | 66 | 75 | (12)% | | **Net Income** | 47 | 61 | (23)% | | **Diluted EPS ($)** | $ 0.38 | $ 0.45 | (15)% | | **Non-GAAP Operating Income** | 69 | 76 | (10)% | | **Non-GAAP Net Income** | 51 | 57 | (11)% | | **Non-GAAP Diluted EPS ($)** | $ 0.41 | $ 0.42 | (2)% | - SUBLOCADE net revenue declined modestly by **2% YoY to $176m**, attributed to dispense volume decline in the justice system channel from near-term funding gaps, which offset solid growth in the organized health system (OHS) channel[3](index=3&type=chunk) - U.S. SUBOXONE Film net revenue declined due to intensified competition from generic film providers, with its share of the oral buprenorphine market falling to **14.8% in Q1 2025** from 17.5% in Q1 2024[10](index=10&type=chunk) - **CEO Mark Crossley announced he will be stepping down** in the upcoming month, with Joe Ciaffoni set to lead the company's next chapter[2](index=2&type=chunk) [Business & Strategic Updates](index=2&type=section&id=Business%20%26%20Strategic%20Updates) The company advanced SUBLOCADE with FDA label changes but faced a pipeline delay for INDV-2000 - The FDA approved key label changes for SUBLOCADE in February 2025 to improve treatment flexibility and experience[7](index=7&type=chunk) - - **Rapid Initiation Protocol:** Allows SUBLOCADE initiation after a single transmucosal buprenorphine dose and a one-hour observation period - - **Alternative Injection Sites:** Administration is now approved for the abdomen, thigh, buttock, or back of the upper arm[10](index=10&type=chunk) - - **INDV-2000 (OREXIN-1 Antagonist):** The estimated last subject visit for the Phase 2 study is now expected in H1 2026, a delay from the previous Q4 2025 estimate, due to slower-than-expected subject enrollment - - **INDV-6001 (3-Month Buprenorphine LAI):** The Phase 2 PK study is on track, with the last subject visit expected in Q4 2025[10](index=10&type=chunk) - The fourth **$100m share repurchase program was completed** on January 31, 2025, under which 9,415,726 ordinary shares were repurchased and canceled[7](index=7&type=chunk) [FY 2025 Financial Guidance](index=2&type=section&id=FY%202025%20Financial%20Guidance) The company reaffirms its full-year 2025 guidance, projecting net revenue of $955 million to $1,025 million - The Company's guidance for FY 2025 under U.S. GAAP remains unchanged[8](index=8&type=chunk) **FY 2025 Guidance** | Metric | FY 2025 Guidance | | :--- | :--- | | **Net Revenue (NR)** | $955m to $1,025m | | **SUBLOCADE NR** | $725m to $765m | | **OPVEE NR** | $10m to $15m | | **Non-GAAP Gross Margin** | Low to mid-80s % range | | **Non-GAAP SG&A** | ($525m) to ($535m) | | **Non-GAAP R&D** | ($85m) to ($90m) | | **Non-GAAP Operating Income** | $185m to $225m | - Guidance assumes no material changes to Medicaid eligibility, federal funding levels, or significant impacts from U.S. or retaliatory tariffs[9](index=9&type=chunk) [Q1 2025 Financial Performance Review](index=4&type=section&id=Q1%202025%20Financial%20Performance%20Review) Q1 net revenue fell 6% to $266 million, with lower gross margin partially offset by reduced operating expenses [Net Revenue](index=4&type=section&id=Net%20Revenue) Total net revenue declined 6% to $266 million, driven by an 8% drop in U.S. revenue from competitive pressures **Q1 2025 Net Revenue Breakdown ($m)** | Region/Product | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | **Total U.S.** | 222 | 241 | | *SUBLOCADE (U.S.)* | 163 | 168 | | *PERSERIS* | 4 | 11 | | **Rest of World** | 44 | 42 | | **Total Net Revenue** | **266** | **284** | - The decrease in U.S. NR was primarily driven by the decline in SUBOXONE Film due to intensified generic competition and the discontinuation of PERSERIS promotion in July 2024[14](index=14&type=chunk) [Profitability and Expenses](index=4&type=section&id=Profitability%20and%20Expenses) Gross margin fell to 83% while SG&A and R&D expenses decreased, resulting in a net income of $47 million - Gross margin declined to **83% from 87% YoY**, primarily due to favorable manufacturing variances for SUBLOCADE inventory sold in Q1 2024[16](index=16&type=chunk) - Non-GAAP SG&A expense **decreased 8% to $130m**, reflecting benefits from streamlining actions, including the discontinuation of PERSERIS[17](index=17&type=chunk) - R&D expense **decreased 19% to $22m**, reflecting actions to refocus the development pipeline on Phase 2 OUD assets[18](index=18&type=chunk) - Net interest expense increased to **$7m from $2m in Q1 2024**, reflecting new borrowing secured in Q4 2024[20](index=20&type=chunk) [Balance Sheet and Cash Flow](index=5&type=section&id=Balance%20Sheet%20and%20Cash%20Flow) Cash and investments rose to $400 million, boosted by strong operating cash flow from a temporary rebate delay - Cash and investments **increased by $53m** during the quarter to a total of **$400m** at March 31, 2025[25](index=25&type=chunk) - The cash increase was primarily due to cash from operations and a **c. $100m reduction in net working capital** from the late receipt of government rebate invoices, partially offset by $65m in litigation settlement payments[25](index=25&type=chunk) - Cash provided by operating activities was **$75m in Q1 2025**, a significant improvement from the $37m cash used in operating activities in Q1 2024[26](index=26&type=chunk) [Revision to Previously Issued Financial Statements](index=5&type=section&id=Revision%20to%20Previously%20Issued%20Financial%20Statements) The company corrected its accrual methodology for the U.S. Branded Fee, revising prior SG&A expense figures - The company revised its financial statements to correct the accrual methodology for the U.S. 'Branded Fee'[28](index=28&type=chunk) - This resulted in correcting an immaterial overstatement of SG&A by **$6m in 2024, $4m in 2023, $4m in 2022, and $2m before 2022**, with a cumulative impact of $16m to Accounts Payable and Accrued Expenses at Dec 31, 2024[28](index=28&type=chunk) [Consolidated Financial Statements (Unaudited)](index=9&type=section&id=Consolidated%20Financial%20Statements%20(Unaudited)) This section presents the unaudited Q1 2025 statements of operations, balance sheets, and cash flows [Consolidated Statements of Operations](index=9&type=section&id=Consolidated%20statements%20of%20operations) **Consolidated Statements of Operations (Three Months Ended March 31)** | (In millions) | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net revenue | $ 266 | $ 284 | | Gross profit | 221 | 246 | | Operating income | 66 | 75 | | Income before income taxes | 59 | 73 | | Net income | $ 47 | $ 61 | | Diluted EPS | $ 0.38 | $ 0.45 | [Consolidated Balance Sheets](index=10&type=section&id=Consolidated%20balance%20sheets) **Consolidated Balance Sheets (in millions)** | | Mar 31, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | **Total current assets** | $ 883 | $ 827 | | **Total assets** | **$ 1,375** | **$ 1,316** | | **Total current liabilities** | $ 1,005 | $ 924 | | **Total liabilities** | **$ 1,660** | **$ 1,652** | | **Total shareholders' deficit** | **$ (285)** | **$ (337)** | [Consolidated Statements of Cash Flows](index=11&type=section&id=Consolidated%20statements%20of%20cash%20flows) **Consolidated Statements of Cash Flows (Three Months Ended March 31, in millions)** | | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $ 75 | $ (37) | | Net cash (used in) provided by investing activities | $ (5) | $ 25 | | Net cash used in financing activities | $ (17) | $ (56) | | **Net increase (decrease) in cash and cash equivalents** | **$ 53** | **$ (68)** | | **Cash and cash equivalents at end of period** | **$ 372** | **$ 248** | [Selected Revenue and Expense Information](index=12&type=section&id=Selected%20revenue%20and%20expense%20information) **Q1 Net Revenue by Product ($m)** | Three Months Ended March 31, | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | **US:** | | | | SUBLOCADE | $ 163 | $ 168 | | Sublingual & other | 54 | 63 | | PERSERIS | 4 | 11 | | **Total U.S.** | **222** | **241** | | **Rest of World** | **44** | **42** | | **Net revenue** | **$ 266** | **$ 284** | [Reconciliation of GAAP to non-GAAP Financial Information](index=13&type=section&id=Reconciliation%20of%20GAAP%20to%20non-GAAP%20financial%20information) **GAAP to Non-GAAP Reconciliation Summary (Q1 2025, $m)** | Measure | GAAP | Adjustments | Non-GAAP | | :--- | :--- | :--- | :--- | | **Operating Income** | $66 | $3 | $69 | | **Net Income** | $47 | $3 | $51 | | **Diluted EPS** | $0.38 | | $0.41 | [Appendix](index=5&type=section&id=Appendix) This section provides supplementary details, including investor contacts, non-GAAP definitions, and safe harbor statements