• SUBLOCADE Year-over-Year Growth: Expected to show 17% growth at the midpoint for fiscal year 2024.

• SUBLOCADE Net Revenue Forecast: Revised guidance due to increased competition and market dynamics.

• SUBLOCADE Long-Term Potential: Greater than $1.5 billion peak net revenue potential.

• Market Share Stabilization: SUBLOCADE's share stabilizing over the past four months, maintaining leadership in the long-acting injectable category.

• SUBLOCADE Label Updates: Priority Review granted by FDA for updates including alternate injection sites and rapid induction capabilities.

• Justice Team Expansion: Approximately 120 new Justice entities added through the second quarter, with increased patient treatment.

• Warning! GuruFocus has detected 3 Warning Signs with INDV.

Release Date: October 10, 2024

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

Positive Points

• Indivior PLC (NASDAQ:INDV) continues to see strong interest and intention to treat with SUBLOCADE among criminal justice system (CJS) accounts, indicating long-term growth potential.

• The company expects solid year-over-year growth for SUBLOCADE in fiscal year 2024, with a projected 17% increase at the midpoint.

• SUBLOCADE's unique product profile, including rapid induction and alternate injection sites, is expected to maintain its leadership position in the long-acting injectable category.

• Indivior PLC (NASDAQ:INDV) has been granted Priority Review by the FDA for important label updates, which could enhance SUBLOCADE's patient experience and market appeal.

• The company is actively seeking efficiencies to fuel SUBLOCADE's growth and support margins, including increased investment in awareness and sales force expansion.

Negative Points

• Indivior PLC (NASDAQ:INDV) is facing increased competitive pressure, with competitors gaining initial adoption among SUBLOCADE prescribers faster than expected.

• The company is experiencing unpredictable volumes and modest pricing pressure in the criminal justice system channel due to funding variability.

• SUBLOCADE's net revenue forecasting accuracy is difficult in the near term due to increased competition and destocking impacts.

• Indivior PLC (NASDAQ:INDV) no longer expects to deliver a $1 billion annual net revenue run rate for SUBLOCADE by the end of 2025 due to slower growth expectations.

• The company has issued multiple profit warnings, raising concerns about the stability and predictability of its financial performance.

Q & A Highlights

Q: Given the recent profit warnings, what confidence can you provide that there won't be another one, and is the $1.5 billion peak revenue target for SUBLOCADE still achievable? A: Mark Crossley, CEO, explained that the recent market volatility was due to intensified competition, funding fluctuations, and stocking levels. The company has incorporated these learnings into their guidance, giving them confidence in their current projections. While they haven't specified timing for the $1.5 billion peak revenue, they remain confident in achieving it due to strong market data and physician feedback.