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]

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 ...