Indivior Pharmaceuticals, Inc. Q3 FY2024 earnings call

• Results: Third quarter showed solid double-digit YOY growth, in line with preannounced expectations. Adjusted operating profit was $97 million, up 62%, and cash position at end of third quarter was $344 million.
• SUBLOCADE: U.S. patients and treatment grew 37% YOY to 166,600; active dispensing HCPs increased to over 7,700; justice system accounts reached over 800; alternate injection sites ~1,220, injections +60% QoQ. Label updates for SUBLOCADE submitted to FDA with Priority Review, PDUFA Feb 7, 2025.
• Pipeline: AELIS Phase 2b study failed, INDV-1000 discontinued; narrowed pipeline to OUD with INDV-6001 and INDV-2000; INDV-6001 initiated multiple dose PK study, INDV-2000 Phase 2 proof-of-concept study ongoing.
• Cost reductions: Focus on G&A and R&D reprioritization; aim to reduce total operating expense $10M-$20M in 2025 vs 2024 midpoint.
• Litigation: Preliminary $40M settlement for legacy antitrust cases, with material terms to be negotiated.

Total third quarter net revenue was $307 million, up 13% year-over-year. SUBLOCADE third quarter net revenue was $191 million, a 14% increase, contributing 62.2% to total net revenue. Ex U.S. sales of SUBLOCADE grew 30% year-over-year to $13 million. OPVEE net revenue for the quarter was $15 million from two BARDA orders. SUBOXONE film had net revenue with a benefit from trade spend catch-up due to normalized claims data after a cyberattack.

• Revised total net revenue guidance: $1.125 billion to $1.165 billion, midpoint 5% YOY growth.
• SUBLOCADE guidance: $725 million to $745 million, 17% YOY growth at midpoint, impacted by competition, CGS funding, and destocking.
• OPVEE guidance: ~$15 million net revenue for year, based on BARDA orders.
• SG&A expense guidance: $555 million to $560 million; R&D guidance: $115 million to $120 million; adjusted operating income expected $260 million to $280 million.

• Competition: Impacting SUBLOCADE growth, including competitor product adoption and CGS funding fluctuations.
• Pipeline: AELIS Phase 2b study failing and INDV-1000 discontinued pose risks.
• Litigation: Uncertainties remain despite preliminary settlements for legacy antitrust cases.

Q: First on the competitive landscape. Can you just talk about how you're thinking about your share of new starts longer term, and what you think ultimately the market will shake out as you think you'll be getting half of new starts? Is it something higher? Is it something lower?

A: Thanks, David. I think when we think about the competitive landscape, the early data certainly is encouraging. When you look at new patient share continuing to be above 70%, you look at the cohorts from the early adopters stabilizing out in the mid-60% range. And we see that as incredibly indicative, of the very unique profile that SUBLOCADE offers in this space...

Q: Assuming kind of approval in Q1 Mark, for your label updates for SUBLOCADE. Can you help us with kind of the strategy to drive awareness, within your commercial organization with clinicians on these changes?

A: I think these are important updates, and we think are important moving forward. As we think about our incremental investments. Obviously, some of those are on HCP and patient awareness of not only SUBLOCADE, but of the new developments with regards to its label and the improvements in the patient and doctor experience...

Q: First on the Q4 visibility over SUBLOCADE, and the kind of implicit range that your $725 million to $745 million guidance gives. I mean how can that '25 possibly be viable given the sort of stable patient trends, and as you just said, the sort of stable pricing?

A: Yes. When we look at SUBLOCADE, and we look at the trends going into 2025, and we look at the top end of guidance to the bottom end of guidance. What we taken into account Paul, is continuation of the accelerated adoption of the competitor product, as we go through this transition period. The continuation of CGS kind of in year funding fluctuations, and then the continued destocking through Q4, is what we've built into that forecast...