[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

Revenue and Market Share - The U.S. accounted for 85%, 83%, and 81% of net revenues for the years ended December 31, 2024, 2023, and 2022, respectively[51]. - The company has a significant share of oral buprenorphine medication-assisted treatment (BMAT) at 50%, 51%, and 49% in 2024, 2023, and 2022, respectively[67]. - Indivior's marketed products generated net sales of $756 million for SUBLOCADE and $374 million for SUBOXONE Film in 2024[111]. - The market share of SUBOXONE Film has declined to an average of 16% in 2024, facing competition from five generic competitors in the U.S.[128]. - Approximately 85% of the company's net revenues come from the U.S. market, which is not a single payor market but a complex system involving federal and state agencies[159]. - In 2024, 85% of the company's net revenues were derived from the U.S., down from 83% in 2023 and 81% in 2022[181]. - The company's three largest customers accounted for 55% of global net revenues in 2024, with the largest customer contributing 19%[184]. Product Development and Approvals - SUBLOCADE became the largest product by net revenue for the company by the second quarter of 2022[62]. - OPVEE (nalmefene) nasal spray was approved by the FDA in May 2023 and began marketing in October 2023[63]. - The FDA approved label changes for SUBLOCADE on February 24, 2025, allowing for a rapid initiation protocol and alternative injection sites[75]. - The company launched sales of SUBLOCADE in 2018, which is the first long-acting buprenorphine-based injectable for OUD[62]. - OPVEE (nalmefene) nasal spray was approved by the FDA on May 22, 2023, for emergency treatment of opioid overdose, with an onset of action of 2.5 to 5 minutes[124][125]. - SUBLOCADE is the first long-acting buprenorphine-based injectable approved by the FDA for moderate to severe opioid use disorder (OUD) treatment, showing increased abstinence from illicit opioids compared to placebo[112]. - The RECOVER extension study demonstrated improved patient-reported quality-of-life outcomes, including health status and employment, for patients receiving SUBLOCADE[112]. - The FDA approved label changes for SUBLOCADE on February 24, 2025, allowing rapid initiation of treatment after a single dose of transmucosal buprenorphine[114]. - SUBLOCADE can now be administered subcutaneously in multiple sites, enhancing flexibility for patients and healthcare providers[115]. - The company is developing INDV-2000, a non-opioid treatment for moderate to severe opioid use disorder (OUD), with a Phase 2 study expected to complete by the end of 2025[139]. - INDV-6001, a sustained release long-acting injectable prodrug of buprenorphine, has secured global rights with an upfront payment of $10 million and a $5 million option payment, with U.S. patents expiring in 2039[140]. Financial Agreements and Investments - The company agreed to make payments totaling $600 million to federal and state authorities as part of a resolution agreement with the DOJ[72]. - Indivior commenced a share repurchase program of up to $100 million on November 17, 2023, completing it on August 2, 2024, repurchasing 5,944,547 shares at an average price of approximately $16.96[77]. - A new non-discretionary share repurchase program of $101 million was announced on July 25, 2024, which commenced on August 5, 2024, and completed on January 31, 2025, repurchasing 9,415,726 shares at an average price of approximately $10.71, representing about 6.4% of diluted shares outstanding[78]. - On November 4, 2024, Indivior repaid the outstanding balance under its existing credit agreement and entered into a Note Purchase Agreement for the issuance of up to $400 million in senior secured notes, including $350 million in term notes[79]. - A $32 million contract was awarded to the company by BARDA to support post-marketing studies and procurement of OPVEE as a medical countermeasure[135]. - The company has coverage from approximately 90% of payors for its OUD products, including nearly all commercial insurance payors and government programs[160]. Regulatory and Compliance - The FDA user fee rate for NDA submissions in fiscal year 2024 is set at $4,310,002, while for NDAs not requiring clinical data, it is $2,155,002[205]. - For fiscal year 2025, the user fee rate for ANDA submissions by large size operation generic applicants is set at $1,891,664[207]. - The FDA requires all NDAs to include assessments on drug safety and effectiveness in pediatric patients unless a waiver is granted[202]. - The FDA may impose civil penalties on drug manufacturers that fail to implement an approved Risk Evaluation and Mitigation Strategy (REMS)[213]. - The SUBOXONE Film and SUBLOCADE Injection are subject to specific REMS programs to mitigate risks associated with their use[214]. - The FDA enforces comprehensive current Good Manufacturing Practices (cGMP) to ensure drug quality and safety throughout the manufacturing process[216]. - The FDA conducts pre-approval and post-approval inspections to ensure compliance with cGMP, impacting drug approval processes[217]. - Pharmaceutical manufacturers must report adverse events during clinical trials and post-approval, with specific reporting timelines for serious events[219]. - The FDA regulates marketing and labeling of pharmaceuticals to prevent false claims, requiring manufacturers to submit promotional materials[220]. - The DEA enforces strict regulations on controlled substances, complicating the import of finished dosage forms from outside the U.S.[225]. - Compliance with federal and state healthcare laws is critical, as violations can lead to significant penalties and operational disruptions[244]. - The Sunshine Act requires pharmaceutical companies to report payments and transfers of value to healthcare providers, enhancing transparency[242]. Market Trends and Challenges - The company faces competition from four generic competitors for SUBOXONE Film in the U.S., with a fifth expected in early 2025[61]. - The company faces competition from generic products and alternative treatments, impacting market share and pricing of its branded products[127]. - The company focuses its sales and marketing efforts on diverse treatment environments, including emergency rooms, hospitals, and rehabilitation centers[157]. - The company has begun offering OPVEE to government entities and community agencies, utilizing grant funding related to the opioid epidemic[162]. - The company has established strong marketing expertise in increasing disease state and treatment awareness through various platforms[179]. - The company faces challenges in the sales process due to the regulatory nature of its products, including the requirement for secure storage and administration by healthcare providers[180]. - Legislative changes may continue to pressure drug pricing and reimbursement methodologies, affecting the pharmaceutical industry's financial outlook[234]. Social Impact and Community Programs - The INSUPPORT Community Reentry Program reached over 100 enrollments in 2023, providing eligible patients with up to two months of SUBLOCADE at no cost while awaiting health insurance reinstatement[104]. - The U.S. Department of Justice issued guidance in April 2022 emphasizing the rights of individuals with opioid use disorder (OUD) to receive treatment, including in correctional settings[108]. - The company collaborates with patient organizations and stakeholders to expand access to evidence-based treatment for substance use disorders[172]. - In 2023, 48.5 million people aged 12 or older (17%) had a substance use disorder (SUD) in the past year, including 28.9 million with an alcohol use disorder and 27.2 million with a drug use disorder[86]. - The U.S. experienced 97,000 fatal overdoses in the 12 months ending July 2024, with 67,952 linked to natural and synthetic opioids[83]. - The European market for opioid use disorder treatment is smaller than the U.S., with an estimated 860,000 high-risk opioid users reported in 2024[93].

Core Viewpoint - Indivior PLC has appointed Joe Ciaffoni as the new Chief Executive Officer, effective upon shareholder approval of a new remuneration policy at the AGM in May 2025 [1][4]. Company Leadership Changes - Joe Ciaffoni, previously an Independent Non-Executive Director since December 2024, has over 30 years of experience in the pharmaceuticals and biotech sectors, including roles at Collegium Pharmaceutical, Endo International, Biogen, and Shionogi Inc. [2] - Mark Crossley will step down as CEO and Board Director after a successful tenure, remaining with the company to support the transition until at least the AGM in May 2025 [3][5]. Company Vision and Mission - Indivior is focused on developing medicines for substance use disorders (SUD) and aims to transform SUD from a global crisis into a recognized chronic disease, ensuring access to evidence-based treatment for all patients [7]. - The company has a global portfolio of opioid use disorder (OUD) treatments and is expanding its pipeline of product candidates in this category [7]. Board Statements - David Wheadon, Chair of Indivior's Board, expressed confidence in Ciaffoni's leadership to drive the next stage of growth and deliver on the company's potential [4]. - Mark Crossley reflected on his decade-long commitment to Indivior, emphasizing the company's role in addressing substance use disorders [6].

Core Insights - The FDA has approved label changes for SUBLOCADE®, introducing a rapid initiation protocol and alternative injection sites, which represents a significant advancement in treating moderate to severe opioid use disorder (OUD) [1][2][3] Summary by Sections Label Changes - The new rapid initiation protocol allows healthcare providers to start treatment with SUBLOCADE after a single dose of transmucosal buprenorphine and a one-hour observation period to confirm tolerability [6] - Alternative injection sites now include the abdomen, thigh, buttock, or back of the upper arm, providing increased flexibility for patients and healthcare providers [6] Clinical Study - A non-inferiority study involving 729 participants demonstrated the effectiveness of rapid induction, with 66.4% of participants in the rapid induction arm receiving the second injection compared to 54.5% in the standard induction arm [4] Commitment to Patient Care - The company emphasizes its dedication to evolving treatment options for individuals with OUD, aiming to improve patient adherence and outcomes through these label changes [3][16] - SUBLOCADE continues to maintain its established safety profile and efficacy while being more adaptable to patient needs [3] Company Overview - Indivior is a global pharmaceutical company focused on developing medicines for substance use disorders, with a vision of providing evidence-based treatment for chronic conditions related to substance use [16]

Financial Data and Key Metrics Changes - The company reported Q4 2024 net revenue of $298 million, a 2% increase from the previous year, driven by SUBLOCADE [49] - Total SUBLOCADE net revenue reached $194 million in Q4, marking a 10% year-over-year increase and a 2% increase from the prior quarter [49] - Full year 2024 net revenue increased by 9%, with total SUBLOCADE net revenue at $756 million, up 20% year-over-year [54] - Adjusted operating profit for full year 2024 grew by 16% to $312 million, reflecting increased top-line growth and lower overall expenses [58] Business Line Data and Key Metrics Changes - SUBLOCADE was the primary growth driver, with a 20% increase in net revenue year-over-year [6][19] - OPVEE net revenue for Q4 was immaterial following two BARDA orders in Q3 [51] - PERSERIS net revenue for Q4 was $9 million, primarily from supply orders to minimize patient disruption [52] Market Data and Key Metrics Changes - The U.S. market for SUBOXONE Film saw a decline in market share to approximately 15%, down three percentage points from the previous year [51] - In the Rest of the World, Q4 2024 net revenue increased by 7% at actual exchange rates, driven by SUBLOCADE [52] Company Strategy and Development Direction - The company is focusing on opioid use disorder and plans to accelerate awareness of SUBLOCADE among patients and healthcare providers [9][10] - Proposed label changes for SUBLOCADE are expected to enhance its competitive positioning [10] - The company has narrowed its commercial and R&D pipeline focus to strengthen its leadership in opioid use disorder [8] Management's Comments on Operating Environment and Future Outlook - Management acknowledged 2024 as a challenging year but expressed confidence in the actions taken to support long-term growth [6][11] - The company anticipates a transition year for SUBOXONE Film and SUBLOCADE in 2025, with expected declines in total net revenue and adjusted operating profit [12][63] - Management expects to achieve SUBLOCADE's peak net revenue goal of over $1.5 billion in the long term [16][74] Other Important Information - The company implemented cost reductions exceeding $100 million annually to support reinvestment in SUBLOCADE and its pipeline assets [9] - The company ended 2024 with gross cash and investments of $347 million, down from $451 million at the end of 2023 [60] - The company expects to generate positive underlying cash flows from operations in 2025 [23] Q&A Session Summary Question: How much of the dynamics in CGS are related to competition? - Management indicated that the funding constraints are primarily tied to budget decisions within facilities rather than competition [82] Question: Can you talk about your share of new starts? - Management reported that they currently have about 71% of new starts, which is consistent with previous quarters [87][88] Question: What is your expectation for SUBOXONE pricing long-term? - Management expects continued pricing pressure due to competition and has factored this into their guidance [116] Question: How do you view the impact of a potential fifth generic entrant? - Management believes they have accounted for the impact of a fifth generic entrant in their guidance [121][123] Question: What are the overall buprenorphine LAI market growth assumptions for 2025? - Management projected market growth between 20% to 30% for 2025, factoring in continued share impact [128]

FY / Q4 2024 Results FEBRUARY 20, 2025 FY / Q4 2024 RESULTS | FEBRUARY 20, 2025 Important Cautionary Statement Regarding Forward-looking Statements This presentation contains certain statements that are forward-looking. Forward-looking statements include, among other things, express and implied statements regarding: the Indivior Group's financial guidance including revenue, operating, and profit margins for 2025, peak net revenue goals for specific products, and its medium- and long-term growth outlook; ass ...

Financial Performance - FY 2024 net revenue (NR) reached $1,188 million, a 9% increase compared to FY 2023[1] - FY 2024 SUBLOCADE® NR was $756 million, reflecting a 20% year-on-year growth; Q4 2024 NR for SUBLOCADE was $194 million[1] - FY 2025 guidance indicates a total NR decline of 17% at the midpoint, primarily due to a projected over 50% decrease in SUBOXONE Film NR[3] - Adjusted operating profit for FY 2024 was $312 million, a 16% increase from FY 2023[12] - FY 2024 adjusted operating profit increased 16% to $312 million from $269 million in FY 2023, driven by higher total net revenue despite increased SG&A expenses[25] - Q4 2024 reported operating profit was $40 million, down from $60 million in Q4 2023, while adjusted operating profit remained unchanged at $66 million[26] - FY 2024 reported net loss was $48 million, while adjusted net income was $222 million, slightly down from $223 million in FY 2023[29] - Net income for Q4 2024 was $9 million, a decrease from $54 million in Q4 2023, with a full year net loss of $(48) million compared to a profit of $2 million in FY 2023[150] - Adjusted net income for Q4 2024 was $41 million, down from $61 million in Q4 2023, while FY 2024 adjusted net income was $222 million, slightly down from $223 million in FY 2023[150] Cost Management and Investments - The company implemented streamlining actions expected to save over $100 million annually, with $50 million reinvested to support SUBLOCADE and OUD pipeline[2] - R&D expenses increased by 34% in FY 2024 to $142 million, reflecting investments in product development[22] - FY 2024 adjusted R&D expenses decreased 3% to $103 million from $106 million in FY 2023, with Q4 2024 adjusted R&D expenses down 10% to $27 million from $30 million in Q4 2023[23] - Selling, general and administrative expenses were adjusted to $576 million in FY 2024, compared to $543 million in FY 2023[146] - Research and development expenses included exceptional items of $39 million for FY 2024, compared to no exceptional items in FY 2023[149] Cash Flow and Liquidity - Cash and investments totaled $347 million at the end of FY 2024, down from $451 million in FY 2023, mainly due to litigation settlement payments and share repurchases[12] - Cash generated from operations in FY 2024 was $84 million, a significant improvement from cash used in operations of $292 million in FY 2023[34] - FY 2024 cash inflow from investing activities was $69 million, compared to an outflow of $98 million in FY 2023, reflecting maturing investments[35] - FY 2024 cash outflow from financing activities was $87 million, up from $46 million in FY 2023, due to share repurchases and cancellations[36] - Cash and cash equivalents remained stable at $319 million at the end of 2024, compared to $316 million at the end of 2023[54] Shareholder Actions - The company repurchased and canceled 9,415,726 shares as part of a $100 million share repurchase program completed on January 31, 2025[14] - The Group repurchased and canceled a total of 4,532,000 ordinary shares at $0.50 per share under a share repurchase program, with total purchases amounting to $168 million[126] - The Group's share capital decreased to 124,903,000 ordinary shares by December 31, 2024, down from 136,526,000 shares at the beginning of the year[122] Tax and Legal Matters - The effective tax rate for FY 2024 was 25%, up from 19% in FY 2023, influenced by the write-off of deferred tax assets and changes in U.K. tax rates[28] - The effective tax rate for FY 2024 was 71%, significantly higher than 11% in FY 2023, primarily due to the write-off of deferred tax assets and changes in U.K. tax rates[72] - The Group has been named as a defendant in over 400 civil lawsuits related to opioid marketing practices, with most cases consolidated in a federal multi-district litigation[114] - The Group intends to vigorously defend itself against all claims not resolved by the proposed settlement, with no estimate of possible loss available at this time[114] Acquisitions and Facilities - The Group acquired 100% of Opiant for an upfront cash consideration of $146 million, with an additional potential payment of $8.00 per share in Contingent Value Rights[127] - The cash outflow for the acquisition of Opiant was $124 million in Q1 2023, net of cash acquired[129] - On November 1, 2023, the Group acquired an aseptic manufacturing facility in the U.S. for $5 million in cash, aimed at securing long-term production of SUBLOCADE[131] - Committed capital spend for the acquired facility is approximately $21 million as of December 31, 2024[133] Operational Challenges - Reported operating loss for FY 2024 was $23 million, compared to a loss of $4 million in FY 2023, primarily due to higher net revenue offset by exceptional expenses and increased sales and marketing investments[24] - The company experienced an operating loss of $23 million in 2024, compared to a loss of $4 million in 2023[54] - The discontinuation of PERSERIS marketing led to a headcount reduction of approximately 130 employees and incurred charges of $61 million in 2024[136] - Impairment charges related to PERSERIS included $20 million for inventory and $9 million for marketed product intangible assets in FY 2024[137] Future Outlook - The company aims for SUBLOCADE's peak net revenue goal of over $1.5 billion, focusing on opioid use disorder treatment[4] - The company plans to address risks related to revenue growth expectations for SUBLOCADE, modeling a potential 10% decline in forecasts[65] - The Group's total finance expense increased to $43 million in FY 2024 from $38 million in FY 2023, influenced by higher interest expenses on borrowings[71]

Core Insights - Indivior PLC announced its financial results for the period ending December 31, 2024, highlighting its ongoing commitment to treating substance use disorders [1] - The company is focused on transforming substance use disorders from a global crisis to a recognized chronic disease, aiming to provide evidence-based treatment to patients worldwide [3] Company Overview - Indivior is a global pharmaceutical company headquartered in Richmond, VA, employing over 1,000 individuals and offering products in over 30 countries [3] - The company specializes in developing medicines for substance use disorders, particularly focusing on opioid use disorder treatments [3] Financial Presentation - A live webcast presentation regarding the financial results will be hosted by CEO Mark Crossley, scheduled for 13:00 BST (8:00 am ET) [2] - The earnings release and investor presentation will be accessible on the company's website [4]

Core Points - Indivior PLC announced a delay in the final review of the label changes for SUBLOCADE, which was initially scheduled for February 7, 2025 [1] - The FDA confirmed that there were no outstanding items to address regarding the proposed label for SUBLOCADE [1] - Indivior will provide further updates on the approval status of the proposed label changes as necessary [2]

Financial Data and Key Metrics Changes - Third quarter net revenue increased by 13% year-over-year to $307 million, driven primarily by SUBLOCADE's performance [4][14] - Adjusted operating profit rose by 62% to $97 million, reflecting strong underlying profitability [4][17] - Cash position at the end of the third quarter was $344 million, with a year-to-date positive cash flow from operations [4][17] Business Line Data and Key Metrics Changes - SUBLOCADE's net revenue for the third quarter was $191 million, a 14% increase year-over-year [4][14] - U.S. patients treated with SUBLOCADE grew by 37% year-over-year to 166,600, with a sequential increase of 4% [7] - OPVEE generated net revenue of $15 million in the quarter, reflecting two orders from BARDA [15] Market Data and Key Metrics Changes - U.S. net revenue grew by 15%, while the rest of the world business grew by 5% at actual currency [14] - SUBLOCADE maintained a 72% share of new patients at the end of the third quarter, with mid-60s percentage share levels across various co-prescribing cohorts [5][25] Company Strategy and Development Direction - The company is focused on streamlining operations and reducing G&A costs to sharpen strategic focus on SUBLOCADE's growth [6][20] - Plans to enhance awareness and adoption of SUBLOCADE following label updates expected in February 2025 [10][30] - The company aims to achieve peak net revenue of over $1.5 billion for SUBLOCADE [7][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the underlying fundamentals of the business despite a challenging market backdrop for SUBLOCADE [22] - The competitive landscape is expected to stabilize, with significant unmet needs in the market for opioid use disorder treatments [25][26] - The company anticipates continued growth in the opioid use disorder market, with a focus on patient access and treatment options [5][36] Other Important Information - A preliminary agreement for a $40 million settlement to resolve legacy antitrust cases was reached, with expectations to finalize shortly [6][18] - The company is narrowing its pipeline focus to opioid use disorder, discontinuing INDV-1000 for alcohol use disorder [10][21] Q&A Session Summary Question: Competitive landscape and market share expectations - Management indicated that SUBLOCADE's new patient share remains above 70%, with potential for growth in a two-player market [25][26] Question: Capital deployment and share buybacks - The company plans to continue share buybacks while maintaining flexibility for future capital allocation [26][27] Question: Strategy for driving awareness of label updates - Incremental investments will focus on clinician and patient awareness of SUBLOCADE's new developments post-approval [30][31] Question: Clarification on cohort data and market dynamics - Management clarified that the cohort data reflects a mix of co-prescribing, with a significant opportunity for both products in the market [44][45] Question: Visibility over SUBLOCADE's Q4 performance - Guidance for SUBLOCADE reflects anticipated competitive adoption and funding fluctuations, with a range of $725 million to $745 million [40][41]