• Fourth Quarter Net Revenue: $298 million, up 2% from last year.
• Fourth Quarter SUBLOCADE Net Revenue: $194 million, increased 10% year-over-year.
• Full Year 2024 SUBLOCADE Net Revenue: $756 million, up 20% year-over-year.
• Full Year 2024 Net Revenue: Increased 9%, driven by SUBLOCADE.
• Adjusted Gross Margin for Fourth Quarter: 83%.
• Adjusted Operating Profit for Full Year 2024: Grew by 16% to $312 million.
• Cash and Investments at End of 2024: $347 million.
• Cost Reductions: Over $100 million on an annual basis.
• 2025 Net Revenue Guidance: $955 million to $1,025 million.
• 2025 SUBLOCADE Net Revenue Guidance: $725 million to $765 million.
• 2025 SG&A Expense Guidance: $525 million to $535 million.
• 2025 R&D Expense Guidance: $85 million to $90 million.
• 2025 Adjusted Operating Profit Guidance: $185 million to $225 million.

• Warning! GuruFocus has detected 4 Warning Signs with INDV.

Release Date: February 20, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Indivior PLC (NASDAQ:INDV) achieved a 20% net revenue growth for its primary product, SUBLOCADE, in 2024.
• The company implemented cost reductions of over $100 million annually, contributing to more than $50 million in savings.
• Indivior PLC (NASDAQ:INDV) resolved certain legacy litigation, reducing enterprise risk and enhancing financial flexibility.
• The company is optimistic about FDA approval for label changes to SUBLOCADE, which could improve its competitive positioning.
• Indivior PLC (NASDAQ:INDV) is investing in commercial strategies to increase awareness of SUBLOCADE, aiming to expand the market and increase market share.

Negative Points

• Indivior PLC (NASDAQ:INDV) faced challenges in 2024, including competition in the US long-acting injectable category and the discontinuation of its schizophrenia treatment, PERSERIS.
• The company expects a sharp decline in net revenue from SUBOXONE Film in 2025 due to intensified competitive generic pricing activity.
• SUBLOCADE's net revenue is anticipated to remain relatively unchanged in 2025 due to competitive dynamics and funding challenges in the justice system.
• Indivior PLC (NASDAQ:INDV) projects a decline in total net revenue and adjusted operating profit for 2025 compared to 2024.
• The company is not currently considering business development or a return of capital to shareholders, focusing instead on reinvesting in SUBLOCADE and completing clinical studies.

Q & A Highlights

Q: Can you discuss the impact of competition in the Criminal Justice System (CJS) and your market share expectations for new starts? A: Mark Crossley, CEO, explained that the pricing environment remains constructive, with PBMs focused on full access. Ryan Preblick, CFO, noted that the demand within facilities is strong, but budget constraints are the primary issue, not competition. Richard Simkin, CCO, added that they have about 71% of new starts, with the market stabilizing around a 65-35 share split favoring SUBLOCADE.

Q: How do you view the pricing and market dynamics for SUBOXONE Film, especially with potential new generic entrants? A: Mark Crossley, CEO, stated that they have factored in continued price erosion throughout the year, whether driven by current competitors or a potential fifth entrant. Ryan Preblick, CFO, added that they have adjusted pricing in Medicaid to maintain formulary access, anticipating a 55% decline in net revenue for 2025.

Q: What are your expectations for SUBLOCADE's growth in the Organized Health Systems (OHS) market, and how do label changes and marketing investments factor into this? A: Ryan Preblick, CFO, mentioned that they expect high single-digit to low double-digit growth in OHS, factoring in market dynamics and investments in HCP and patient awareness. Richard Simkin, CCO, highlighted the significant growth opportunity in category penetration and the potential impact of label changes and increased marketing efforts.

Q: Can you elaborate on the funding challenges in the CJS and potential solutions? A: Mark Crossley, CEO, explained that funding constraints are due to budget limitations, not competition. He mentioned that Medicaid 1,115 waivers and abatement funds could help alleviate these constraints, with operationalization expected to start in 2026.

Q: What is the outlook for OPVEE's profitability and R&D expenses? A: Ryan Preblick, CFO, stated that OPVEE costs are aligned with strategic programs and are expected to be accretive next year. R&D expenses are focused on phase 2 OUD assets and generating real-world evidence, reflecting a narrowed strategic focus.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.