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]

张INDIVIOR Q3 2024 Results October 24, 2024 Q3 2024 Results | October 24, 2024 2 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: strategic priorities, strategies for value creation, and operational goals; expected future growth and the timing and amount of sales of particular products; the Indivior Group's financial guida ...

Financial Performance - Q3 2024 total net revenue (NR) was $307 million, representing a 13% increase compared to Q3 2023[1] - YTD 2024 total NR reached $889 million, an 11% increase from YTD 2023[4] - SUBLOCADE Q3 2024 NR was $191 million, up 14% from Q3 2023, with YTD 2024 NR of $562 million, a 24% increase[1] - Adjusted operating profit for Q3 2024 was $97 million, a 62% increase from Q3 2023, while YTD 2024 adjusted operating profit was $245 million, up 21%[4] - FY 2024 net revenue guidance is set between $1,125 million and $1,165 million, with SUBLOCADE NR expected between $725 million and $745 million[6] - Net revenue for YTD 2024 was $889 million, up from $800 million in YTD 2023, reflecting a strong performance[25] - Q3 2024 net income on an adjusted basis was $72 million, compared to $49 million in Q3 2023[11] - Adjusted net income for YTD 2024 was $182 million, compared to $162 million for YTD 2023, indicating an increase of 12.3%[112] Cash and Investments - Cash and investments totaled $344 million as of September 30, 2024, down from $451 million in FY 2023, primarily due to litigation settlement payments and share repurchases[4] - Cash generated from operations in YTD 2024 was $94 million, a turnaround from cash used in operations of $2 million in YTD 2023[13] - Cash outflow from financing activities in YTD 2024 was $129 million, significantly higher than $25 million in YTD 2023, primarily due to share repurchases[13] - Cash and cash equivalents decreased from $316 million to $288 million, a decline of approximately 9%[28] Expenses and Profitability - YTD 2024 adjusted SG&A expense increased 7% to $421 million, while Q3 2024 adjusted SG&A expense decreased 11% to $133 million[11] - Q3 2024 operating profit was reported at $4 million, a significant improvement from a loss of $183 million in Q3 2023[11] - The effective tax rate for YTD 2024 was 23%, up from 21% in YTD 2023, influenced by an increase in the U.K. corporation tax rate[11] - The company reported a net loss for YTD 2024 of $57 million, a slight increase from a loss of $52 million in YTD 2023[112] Litigation and Provisions - A provision of $39 million was recorded for the preliminary agreement related to legacy antitrust litigation[3] - The provision for opioid litigation at September 30, 2024, is $78 million, reflecting the present value of a preliminary settlement expected to be paid over five years[62] - The Group has recorded a provision of $39 million for other antitrust matters, representing the net present value of agreed amounts to be paid in 2024 and 2025[62] - Indivior Inc. reached a settlement agreement for $85 million to resolve all remaining claims in the HCSC Consolidated Litigation[72] - The Group recorded a provision of $39 million related to the potential Humana/Centene Settlement, with negotiations ongoing for final terms[72] Assets and Liabilities - Total assets decreased from $1,948 million as of December 31, 2023, to $1,464 million as of September 30, 2024, representing a decline of approximately 25%[28] - Current assets fell from $1,263 million to $799 million, a decrease of about 37%[28] - Total liabilities decreased from $1,948 million to $1,631 million, a reduction of about 16%[28] - The Group's total other liabilities decreased from $492 million at December 31, 2023, to $391 million at September 30, 2024[63] Shareholder Activities - The Group commenced a share repurchase program of $100 million in August 2024, with a current liability of $16 million as of September 30, 2024[69] - The Group issued 1,456 thousand ordinary shares at $0.50 each during the period, compared to 1,943 thousand shares issued in the same period of 2023[83] - The Group repurchased and canceled a total of 4,532 thousand ordinary shares at $0.50 per share under a share repurchase program, with a total cost of $122 million, significantly higher than $11 million in the previous year[85] Acquisitions and Impairments - The acquisition of Opiant was completed for an upfront cash consideration of $146 million, with an additional potential payment of up to $8.00 per share based on sales milestones[86] - The Group incurred impairment charges of $42 million in Q2 2024 related to the discontinuation of PERSERIS sales and marketing, with additional charges of $21 million recorded in Q3 2024[92] - The Group discontinued its collaboration agreement for the CT-102 digital therapeutic product, incurring contract termination fees of approximately $7 million and a non-cash impairment charge of approximately $8 million[94] Market Outlook - The company expects SUBLOCADE peak net revenue to exceed $1.5 billion, driven by strong execution and potential FDA label updates[2] - U.S. buprenorphine medication-assisted treatments (BMAT) are projected to grow in the mid- to high-single digit percentage range long-term due to increased public awareness and regulatory actions[9]

NEW YORK, Sept. 23, 2024 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Indivior PLC (NASDAQ: INDV). Shareholders who purchased shares of INDV during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: https://securitiesclasslaw.com/securities/indivior-loss-submission-form/?id=104033&from=4 CLASS PERIOD: February 22, 2024 to July ...

SAN DIEGO, Sept. 13, 2024 (GLOBE NEWSWIRE) -- A class action lawsuit has been filed on behalf of purchasers or acquirers of Indivior PLC (NASDAQ: INDV) ("Indivior" or the "Company") securities between February 22, 2024 and July 8, 2024, inclusive (the "Class Period"), charging the Company and certain senior executives with violations of the federal securities laws (collectively, "Defendants"). Indivior investors have until October 1, 2024, to seek appointment as lead plaintiff of the Indivior class action l ...

Financial Data and Key Metrics - Total net revenue for Q2 2024 was $299 million, reflecting an 8% growth year-over-year [66] - Adjusted net income grew 7% in Q2 to $60 million [11] - Adjusted gross margin was 84% in Q2, slightly up from the prior year [67] - Gross cash and investments stood at $405 million at the end of Q2 [11] - Adjusted operating income for Q2 was $79 million, up 11% year-over-year [85] - Full-year 2024 net revenue guidance revised to $1.15 billion to $1.215 billion, representing 8% year-over-year growth at the midpoint [28] Business Line Performance - SUBLOCADE net revenue grew 24% year-over-year to $192 million in Q2 [60] - SUBLOCADE dispenses increased 25% year-over-year and 5% sequentially to 155,700 [22] - SUBLOCADE patients and treatments grew 49% year-over-year to 160,400 at the end of Q2 [22] - SUBLOCADE net revenue outside the US grew 30% year-over-year to $13 million in Q2 [84] - SUBOXONE film's average market share was approximately 16% in Q2, down from Q1 and the year-ago quarter [10] - OPVEE net revenue for FY 2024 is expected to be $9 million to $14 million, with $8 million from the BARDA contract [86] Market Performance - US net revenue grew 12% in Q2, while the rest of the world business declined 10% (8% excluding FX) [26] - Ex-US sales of SUBLOCADE grew 25% year-over-year in H1 to $25 million, led by Canada and the Nordics [23] - SUBLOCADE dispensing HCPs increased to over 7,200 from approximately 6,700 at the end of FY 2023 [21] - Over 700 justice system accounts were activated in 2024, with 120 new CGS facilities added [21] Strategy and Industry Competition - The company aims to achieve a $1 billion net revenue run rate for SUBLOCADE by the end of 2025 and exceed $1.5 billion in peak annual net revenue [4] - The company is focusing on increasing awareness of SUBLOCADE among healthcare providers and patients, with 4 out of 5 new patients choosing SUBLOCADE [31] - The company is building a funding trial and experience environment for OPVEE to accelerate adoption [6] - The company discontinued INDV 5004 (Drinabant) due to limited market opportunity [24] Management Commentary on Operating Environment and Future Outlook - The company expects transitory headwinds affecting SUBLOCADE to ease in H2 2024 and into 2025 [60] - Management remains confident in the underlying fundamentals of the business and the strategy to generate shareholder value [87] - The company is transitioning to US GAAP reporting starting with the 2025 Form 10-K filing to support US index inclusion [62] - The company is provisioning $75 million for an expected settlement related to opioid litigation, with the final terms still under negotiation [20][34] Other Important Information - The company announced a new $100 million share repurchase program, reflecting confidence in the business [79] - A $65 million charge was recognized in Q2 related to the cessation of PERSERIS sales and marketing, with an additional $23 million expected in Q3 [9] - The company expects to save approximately $50 million annually from the cessation of PERSERIS, with $20 million included in the revised SG&A guidance for FY 2024 [66] Q&A Session Summary Questions and Answers - **Question:** What is the competitive dynamic with Brixadi, and how does it impact SUBLOCADE's guidance? [88] - **Answer:** The company sees SUBLOCADE as a paradigm shift in treatment and remains confident in its guidance, which includes competitive pressures [71][31] - **Question:** What is the impact of Medicaid disenrollment on SUBLOCADE? [115] - **Answer:** Medicaid disenrollment has impacted retention curves, contributing to a $30 million reduction in SUBLOCADE revenue, but the company expects growth to normalize [117] - **Question:** What are the expectations for the cannabis use disorder (AEF 0117) phase IIB results? [49] - **Answer:** Top-line results are expected in September, and the company will evaluate the data and FDA feedback before deciding on phase III development [50][64] - **Question:** What is the status of the opioid litigation settlement? [99] - **Answer:** The $75 million provision is for a preliminary settlement with municipalities and tribal nations, with final terms still under negotiation [20][34] - **Question:** How is the company addressing pushback from harm reduction advocates for OPVEE? [100] - **Answer:** The company is engaging with advocates through science and real-world evidence to accelerate adoption [6][101] - **Question:** What are the technical constraints for the share buyback program? [105] - **Answer:** The company plans to front-load the buyback program, adhering to trading rules, such as halting purchases if the share price exceeds the 5-day average by 5% [136]

"Our second quarter results are in line with our July 9th business update and reflect +24% NR growth for SUBLOCADE (buprenorphine extended-release injection). The underlying demand for this transformative treatment for moderate-to-severe opioid use disorder (OUD) remains strong in a market that continues to be heavily under-treated. As previously announced, SUBLOCADE's Q2 growth was adversely impacted by transitory items, including Medicaid patient disenrollment dynamics, lower channel stocking and longer s ...

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF THE MARKET ABUSE REGULATION (EU) 596/2014 (AS IT FORMS PART OF DOMESTIC LAW IN THE UK BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018). RICHMOND, Va., July 25, 2024 /PRNewswire/ -- Indivior PLC (Nasdaq/LSE: INDV) ("Indivior" or the "Company"), a leading addiction treatment company, today announced that its Board of Directors has approved a new share repurchase program under which the Company will commence repurchasing Indiv ...

Indivior PLC (NASDAQ:INDV) Business Update Conference Call July 9, 2024 8:00 AM ET Company Participants Jason Thompson - VP, IR Mark Crossley - CEO Conference Call Participants Max Herrmann - Stifel Thibault Boutherin - Morgan Stanley Paul Cuddon - Deutsche Numis Chase Knickerbocker - Craig-Hallum Carl Byrnes - Northland Capital Markets Operator Good day, and thank you for standing by. Welcome to the Indivior Business Update Conference Call. At this time all participants are in listen-only mode. After the s ...

Separately, we are taking decisive action that we believe is in the best interest of shareholders in two areas. First, we are creating greater certainty for all stakeholders by settling with Plaintiffs ahead of our antitrust trial on July 15th. Second, due to anticipated increased payor management of the category that makes PERSERIS' future no longer financially viable, we have determined to take the required actions to discontinue the product. While we believe discontinuing PERSERIS is the right business d ...