Core Insights - Indivior PLC is a specialty pharmaceutical company focused on innovative therapies for opioid dependence and related disorders, maintaining a leading position in the healthcare sector through strategic investments in research and partnerships [1][2] Financial Performance - Indivior generates revenue primarily from proprietary prescription pharmaceuticals targeting substance use and mental health disorders, with notable products including SUBLOCADE, SUBUTEX PRO, SUBOXONE, and OPVEE nasal spray [2] - As of the latest report, shares of Indivior PLC were priced at $35.12, reflecting a 212% increase over the past year, significantly outperforming the S&P 500, which rose by 13% during the same period [3] Investment Activity - Newtyn Management increased its stake in Indivior PLC by nearly 1.6 million shares in the third quarter, raising the position value to $101.3 million, which now accounts for 12.4% of the firm's U.S. equity assets [4][5] Growth and Strategic Changes - Indivior's SUBLOCADE experienced a 15% year-over-year growth in the third quarter, contributing $219 million to total quarterly revenue of $314 million, while adjusted EBITDA rose 14% to $120 million [6][7] - The company is simplifying its global footprint by exiting certain international markets and restructuring R&D, which is expected to generate at least $150 million in annual operating expense savings starting in 2026 [7] Future Outlook - Indivior raised its full-year revenue guidance to approximately $1.2 billion, with a projected adjusted EBITDA midpoint indicating about 15% growth for 2025 [7] - The long-term investment thesis hinges on the growth of SUBLOCADE and the effectiveness of the new operating model in overcoming volatility and a leveraged balance sheet [8]

Indivior Conference Call Summary Company Overview - **Company**: Indivior - **Event**: 37th Annual Piper Sandler Healthcare Conference - **Key Speakers**: Joe Ciaffoni (CEO), Ryan Preblick (CFO) Core Industry and Company Insights Vision and Strategy - Indivior is focused on becoming a leading diversified specialty pharmaceutical company, particularly in the treatment of opioid use disorder through the commercialization of differentiated medicines [2][3] - The company has introduced the "Indivior Action Agenda," a three-phased multi-year operational roadmap aimed at maximizing business value and improving lives affected by opioid use disorder [2] Organizational Changes and Cost Structure - Significant organizational changes have been made to simplify operations and reduce costs, resulting in the removal of $150 million in operating expenses (OPEX) [6] - Future OPEX is projected to not exceed $450 million by 2026 [6] - The company has streamlined its global presence, reducing operations from 41 countries to four key markets: Canada, Australia, France, and Germany, which represent 77% of forecasted net revenue and 94% of forecasted EBITDA [7][12] Research and Development (R&D) - Indivior is committed to advancing its R&D programs, including Indivior 6001 and Indivior 2000, with data readouts expected in early Q2 2026 [9] - The company will focus on commercial stage acquisitions to diversify and enhance growth [10] Product Focus: Sublocade Market Position and Access - Sublocade has achieved approximately 88% payer access in both Medicaid and commercial sectors, with a significant opportunity for growth in commercially covered patients [18] - Currently, Medicaid accounts for 30% of covered lives but over 65% of Sublocade prescriptions, while commercial accounts for 60% of covered lives but only 25% of prescriptions [19] Growth Opportunities - There are 9 million people misusing opioids in the U.S., with only 2 million receiving treatment with buprenorphine, indicating a substantial market opportunity for Sublocade [23] - The criminal justice system is identified as a potential growth area, with efforts to re-establish presence in federal prisons [24] Competitive Landscape - Sublocade maintains a market share stabilizing in the mid-70% range, with new patient share recently surpassing total patient share, indicating strong brand health [26] - The company plans to invest significantly in consumer education and marketing to drive long-acting injectable penetration [27][30] Financial Outlook Operating Margins - Significant margin improvement is anticipated as the company focuses on essential investments and streamlining operations [16] - Specific margin targets were not disclosed, but guidance will be provided before the J.P. Morgan conference [16] Suboxone Dynamics - Suboxone's performance is influenced by generic pricing, with expectations of stable pricing through 2025 and potential share erosion in 2026 due to generic competition [34][35] Business Development and M&A Strategy - Indivior is open to pursuing commercial stage assets that align with its existing infrastructure, focusing on those with peak sales potential of $200 million or more [37][38] - The company aims to ensure that any new acquisitions do not create an overhang from loss of exclusivity (LOE) [38] Conclusion - Indivior is actively working to simplify its operations, enhance its product offerings, particularly Sublocade, and strategically position itself for future growth in the opioid treatment market while maintaining a focus on cost efficiency and profitability [5][6][10][12]

Financial Data and Key Metrics Changes - Total net revenue for Q3 2025 was $314 million, a 2% increase year-over-year, driven by a 15% increase in SUBLOCADE net revenue to $219 million [18][19] - Adjusted EBITDA for Q3 2025 was $120 million, up 14% compared to the same quarter last year, attributed to higher net revenue and lower operating expenses [20] - The company raised its full-year 2025 total net revenue guidance to a range of $1.18 billion to $1.22 billion, reflecting better-than-expected performance [20][21] Business Line Data and Key Metrics Changes - SUBLOCADE experienced a strong 15% year-over-year growth, with dispense volume growth of 8% compared to the prior year [3][19] - The number of active SUBLOCADE prescribers grew by 11% year-over-year, indicating improved commercial execution [12] - SUBOXONE Film pricing remained stable, contributing to the overall revenue despite expected pricing pressure [18][19] Market Data and Key Metrics Changes - In the U.S., total net revenue grew by 2% year-over-year, with adjusted EBITDA increasing by 14% [4] - The market share for SUBLOCADE in the long-acting injectable (LAI) category remained stable at approximately 75% [12] - The company is optimizing its rest of world business, focusing on Australia, Canada, France, and Germany, which together generate 77% of forecasted rest of world net revenue [8] Company Strategy and Development Direction - The company is focused on completing Phase One of the Indivior Action Agenda, "Generate Momentum," and plans to enter Phase Two, "Accelerate," on January 1, 2026 [5][9] - Key priorities include growing SUBLOCADE in the U.S. and simplifying the organization to enhance operational efficiency [6][7] - A new direct-to-consumer campaign, "Move Forward in Recovery," was launched to raise awareness of SUBLOCADE as a treatment option [14][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in finishing 2025 with momentum and entering Phase Two with a strong position [9][25] - The company anticipates significant profitability and cash generation acceleration in 2026 [9][24] - Management emphasized the importance of maximizing the SUBLOCADE opportunity in the U.S. while ensuring essential investments [31] Other Important Information - The company has taken actions to reduce operating expenses by at least $150 million annually starting in 2026, primarily through headcount reduction and discontinuation of non-essential activities [6][30][23] - Non-GAAP operating expenses for Q3 2025 were $145 million, down 3% year-over-year [20] Q&A Session Summary Question: Can you break down the new $150 million OpEx cuts for 2026? - Management indicated that almost half of the $150 million savings is tied to labor, with a headcount reduction of over 32% and discontinuation of non-essential spending [30] Question: How does SG&A as a percentage of revenue compare to industry peers? - Management stated that the focus is on maximizing SUBLOCADE opportunities rather than targeting specific SG&A reductions [31] Question: Can you discuss the opportunity in commercial patients versus Medicaid? - Management highlighted efforts to grow both commercial and Medicaid channels, with a focus on improving commercial execution [37] Question: What are the expectations for SUBLOCADE growth in 2026? - Management is optimistic about maintaining double-digit year-over-year growth for SUBLOCADE, with a focus on commercial execution and direct-to-consumer campaigns [46] Question: What is the outlook for R&D spending going forward? - Management confirmed that R&D spending will be streamlined, focusing on Phase Two assets while preserving capabilities for potential Phase Three advancements [39][56]

Q3 2025 Performance Highlights - Total net revenue increased by 2% to $314 million compared to $307 million in Q3 2024[11] - SUBLOCADE net revenue increased by 15% to $219 million compared to $191 million in Q3 2024[11] - Adjusted EBITDA increased by 14% to $120 million compared to $105 million in Q3 2024[11] Financial Guidance Update - Total net revenue guidance raised to $1180 million - $1220 million, a 1% increase compared to previous guidance[34] - SUBLOCADE net revenue guidance raised to $825 million - $845 million, a 10% increase compared to previous guidance[34] - Adjusted EBITDA guidance raised to $400 million - $420 million, a 15% increase compared to previous guidance[34] Strategic Initiatives - The company is executing Phase I of the Indivior Action Agenda, focusing on generating momentum[13, 42] - Expect at least $150 million in Non-GAAP operating expense savings in 2026[17, 35] - U S SUBLOCADE YTD net revenue growth of 7% to $561 million compared to $524 million[17]

Q2 2025 Performance - Total net revenue increased by 1% to $302 million compared to $299 million in Q2 2024[13, 33] - SUBLOCADE net revenue grew by 9% to $209 million compared to $192 million in Q2 2024[13, 33] - Adjusted EBITDA decreased by 5% to $88 million compared to $93 million in Q2 2024[13, 33] - Gross profit increased by 14% to $250 million, with a gross margin of 83%, a 900 bps increase from 74% in Q2 2024[33] SUBLOCADE Performance - SUBLOCADE dispense growth increased by 6% year-over-year and 9% quarter-over-quarter, reaching 165,700 in Q2 2025[24] - The prescriber base for SUBLOCADE grew by 14% year-over-year, reaching 8,284 prescribers in Q2 2025[24] - The number of healthcare professionals (HCPs) with 5+ SUBLOCADE patients increased by 9% year-over-year[25] - Total SUBLOCADE patients increased by 7% year-over-year, reaching 171,519 in Q2 2025[25] Financial Guidance - The company raised its full-year 2025 total net revenue guidance to $1030 million - $1080 million from the previous guidance of $955 million - $1025 million[14, 39] - The company raised its full-year 2025 Adjusted EBITDA guidance to $275 million - $300 million, a 20% increase at the mid-points, from the previous guidance of $220 million - $260 million[39]

Core Insights - Indivior PLC reported strong financial results for Q2 2025, driven by net revenue growth from SUBLOCADE and pricing stability in SUBOXONE Film, prompting an increase in financial guidance for the year [2][4][6] Financial Performance - Total net revenue for Q2 2025 was $302 million, a 1% increase from $299 million in Q2 2024 [8][20] - SUBLOCADE net revenue reached $209 million, up 9% year-over-year and 19% compared to Q1 2025 [6][8] - U.S. SUBLOCADE net revenue was $195 million, reflecting a 9% increase from Q2 2024 and a 20% increase from Q1 2025 [7][8] - Non-GAAP gross margin for Q2 was 84%, unchanged from Q2 2024 [16] Revised Financial Guidance - The company raised its 2025 financial guidance, with total net revenue now expected to be between $1,030 million and $1,080 million, up from the previous range of $955 million to $1,025 million [4][6] - Adjusted EBITDA guidance was increased to a range of $275 million to $300 million, up from $220 million to $260 million [4][6] Strategic Initiatives - The Indivior Action Agenda is being implemented to enhance operational momentum, focusing on U.S. SUBLOCADE growth and organizational simplification [2][6] - The company has strengthened its executive team and board with new appointments to support its strategic goals [7] Market Position and Developments - Indivior has been included in the Russell 2000® Index and Russell 3000® Index, enhancing its market visibility [7] - New data presented at scientific meetings indicate that higher doses of SUBLOCADE may improve outcomes for patients with high fentanyl use [7]