Indivior PLC (NASDAQ:INDV) Q1 2025 Earnings Conference Call April 24, 2025 8:00 AM ET Company Participants Jason Thompson - Head, IR Mark Crossley - CEO Ryan Preblick - CFO Conference Call Participants Carl Burns - Northland Capital Markets David Amsellem - Piper Sandler Christian Glennie - Stifel Chase Knickerbocker - Craig-Hallum Thibault Boutherin - Morgan Stanley Paul Cuddon - Deutsche Numis Operator Good day, and thank you for standing by. Welcome to the Indivior PLC Q1 2025 earnings call. At this time ...

Exhibit 99.1 The "Company" refers to Indivior PLC and its consolidated subsidiaries. "Our first quarter results were in line with our planning assumptions and consistent with our FY 2025 outlook," said Mark Crossley, Chief Executive Officer. "Net revenue performance was primarily impacted by intensified generic competition for SUBOXONE Film in the U.S. and the discontinuation of PERSERIS in the prior year. SUBLOCADE continued to grow solidly year-over-year in organized health systems (OHS), but as expected, ...

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]

SLOUGH, United Kingdom and RICHMOND, Va., Feb. 20, 2025 /PRNewswire/ -- Indivior PLC (Nasdaq/LSE: INDV) today announced its financial results for the period ending December 31, 2024. The earnings release, investor presentation and webcast are available at www.indivior.com. The earnings release can be found at www.indivior.com/investors The investor presentation can be found at www.indivior.com/investors (at 7:00 am ET) There will be a live webcast presentation at 13:00 BST (8:00 am ET) hosted by Mark Cros ...

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]