Group 1 - The Gross Law Firm has issued a notice to shareholders of Indivior PLC regarding a class action lawsuit due to alleged misleading statements and failure to disclose critical information during the class period from February 22, 2024, to July 8, 2024 [1][2] - Allegations include that Indivior overstated its ability to forecast the negative impact of legislation on its financial prospects and misrepresented the financial outlook for its products, including SUBLOCADE, PERSERIS, and OPVEE [1] - The lawsuit claims that Indivior was unlikely to meet its FY 2024 net revenue guidance due to the negative impact of legislation, and there was a significant risk of ceasing sales and marketing activities related to PERSERIS [1] Group 2 - Shareholders are encouraged to register for the class action by October 1, 2024, to potentially be appointed as lead plaintiffs, although participation in the case does not require this appointment [2] - Once registered, shareholders will receive updates through a portfolio monitoring software regarding the status of the case [2] - The Gross Law Firm aims to protect investors' rights and seeks recovery for losses incurred due to false or misleading statements by companies [3]

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 ...

Core Viewpoint - Indivior PLC has announced a new share repurchase program with a maximum consideration of $100 million to reduce its issued share capital, expected to be completed within six months [2][4]. Group 1: Share Repurchase Program - The new share repurchase program will commence after the completion of the current program, which is expected to finish by the end of July 2024 [10]. - Indivior has entered into a non-discretionary agreement with Morgan Stanley to conduct on-market purchases of ordinary shares as riskless principal [3][11]. - The maximum number of ordinary shares that may be repurchased under the new program is 13,649,017, as authorized by the company's shareholders [12]. Group 2: Company Overview - Indivior is a leading addiction treatment company focused on developing medicines for substance use disorders and related conditions [14]. - The company employs over 1,000 individuals globally and its products are available in 37 countries [7].

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 ...

RICHMOND, Va., May 23, 2024 /PRNewswire/ -- Indivior PLC (LSE: INDV; Nasdaq: INDV), a leading addiction treatment company, announced that in anticipation of the expected primary listing of the Company's shares on Nasdaq , members of Indivior's senior leadership team will be hosting an analyst teach-in event today in New York City. The event, which will be webcast (see details below), is intended to provide an in-depth overview of Indivior's growth and value creation path. During the event, the Company will ...

Financial Performance - Q1 2024 total net revenue increased by 12% to $284 million, compared to $253 million in Q1 2023[6] - SUBLOCADE net revenue for Q1 2024 was $179 million, reflecting a 36% increase year-over-year[15] - Adjusted operating profit for Q1 2024 decreased by 1% to $70 million, down from $71 million in Q1 2023[21] - Reported net income for Q1 2024 was $47 million, with adjusted net income at $51 million, a 9% decrease from $56 million in Q1 2023[23] - U.S. net revenue increased by 15% in Q1 2024 to $241 million, driven by strong SUBLOCADE volume growth[14] - Q1 2024 gross margin was reported at 84%, down from 85% in Q1 2023, with adjusted gross margin at 85%[16] - Gross profit for Q1 2024 reached $238 million, up from $214 million in Q1 2023, reflecting a gross margin improvement[40] - Operating profit increased to $65 million in Q1 2024, compared to $57 million in Q1 2023, representing an increase of 14.0%[40] - Net income for Q1 2024 was $47 million, a rise of 6.8% from $44 million in Q1 2023[41] - Basic earnings per share for Q1 2024 were $0.35, compared to $0.32 in Q1 2023, indicating a 9.4% increase[40] Cash and Investments - Cash and investments totaled $356 million at the end of Q1 2024, down from $451 million at the end of FY 2023[24] - Cash used in operations in Q1 2024 was $25 million, compared to $16 million in Q1 2023, primarily due to litigation settlement payments[26] - The Group's cash and cash equivalents decreased to $248 million at the end of Q1 2024, down from $588 million at the end of Q1 2023[46] - The total investments decreased from $135 million as of December 31, 2023, to $108 million as of March 31, 2024[71] - Net cash outflow from investing activities improved to $25 million in Q1 2024, compared to a net outflow of $(127) million in Q1 2023[46] Guidance and Future Plans - The company reconfirmed its FY 2024 guidance, expecting SUBLOCADE net revenue between $820 million and $880 million[1] - The company plans to seek shareholder approval in May 2024 for a primary listing in the U.S.[10] - Indivior plans to seek shareholder approval in May 2024 for a primary listing in the U.S. while maintaining a secondary listing in the U.K.[36] - The company is focused on expanding its product pipeline to address alcohol use disorder and cannabis use disorder[34] Assets and Liabilities - Total assets as of March 31, 2024, were $1,453 million, down from $1,948 million as of December 31, 2023[43] - Current liabilities decreased to $861 million from $1,306 million at the end of 2023, showing a significant reduction[43] - The Group's term loan borrowings totaled $238 million as of March 31, 2024, slightly down from $239 million as of December 31, 2023[75] - The Group's total liabilities related to the DOJ resolution agreement amounted to $345 million as of March 31, 2024[83] Research and Development - Research and development expenses for Q1 2024 were $28 million, slightly higher than $27 million in Q1 2023, indicating continued investment in innovation[60] Litigation and Settlements - Indivior Inc. reached a settlement with 41 states and the District of Columbia for $103 million in June 2023, and a $30 million settlement with end payors was finalized in December 2023[95] - The company 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[95] - Indivior Inc. has ongoing litigation regarding claims of false or misleading statements under the U.K. Financial Services and Markets Act 2000, with no estimate of possible loss available at this time[98] - A jury trial regarding fraud claims against Indivior Inc. is scheduled for July 15, 2024, with preliminary findings indicating that claims are not barred by the statute of limitations[93] - Indivior Inc. intends to vigorously defend itself against various ongoing litigations, believing it has meritorious defenses[95] Acquisitions - The Group acquired 100% of Opiant for an upfront cash consideration of $146 million, with potential additional payments of up to $8.00 per share based on sales milestones[108] - The acquisition of Opiant added OPVEE, an opioid overdose treatment, to the Group's portfolio, which was FDA approved in May 2023 and launched in October 2023[108] - The cash outflow for the Opiant acquisition was $124 million in Q1 2023, net of cash acquired, and included $10 million of assumed debt[110] - The Group acquired an aseptic manufacturing facility for $5 million in cash on November 1, 2023, to support the production of SUBLOCADE and PERSERIS[112] - Committed capital spend for the aseptic manufacturing facility is approximately $7 million as of March 31, 2024[114] Share Repurchase Program - The Group initiated a share repurchase program with a total purchase price of up to $100 million, repurchasing 1,988,000 ordinary shares at $0.50 per share, totaling $1 million[106] - The total cost of share repurchases during the period was $36 million, an increase from $33 million in FY 2023, with a net repurchase amount of $9 million recorded as a financial liability[107] - The Group's share repurchase program concluded in February 2023, having repurchased up to $100 million worth of shares[105]

Indivior PLC (INDV) came out with quarterly earnings of $0.37 per share, missing the Zacks Consensus Estimate of $0.38 per share. This compares to earnings of $0.40 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -2.63%. A quarter ago, it was expected that this company would post earnings of $0.28 per share when it actually produced earnings of $0.43, delivering a surprise of 53.57%.Over the last four quarters, the company has ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023. OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of ...

Q4 / FY 2023 Results | February 22, 2024 This presentation contains certain statements that are forward-looking. Forward-looking statements include, among other things, statements regarding the Indivior Group's financial guidance including operating and profit margins for 2024 and its medium- and long-term growth outlook; assumptions regarding expected changes in market share and expectations regarding the extent and impact of competition; assumptions regarding future exchange rates; strategic priorities, s ...