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Indivior (INDV) Q4 FY25 earnings call: guidance and Q&A

Earnings call· Dec 2025 (Q4 FY25)· Health Care· Feb 26, 2026

Source: earnings call transcript

Executive summary

Indivior Q4 FY25 — SUBLOCADE Momentum and Strong 2026 Outlook

Indivior completed Phase I of its Action Agenda, generating momentum for SUBLOCADE and strengthening its financial profile. The company is now executing Phase II, "Accelerate," focusing on mid-teens SUBLOCADE dispense unit growth and significant adjusted EBITDA and cash flow expansion in 2026. Management also outlined a disciplined capital deployment strategy, including a new share repurchase program and criteria for future business development.

Highlights

5

  • SUBLOCADE net revenue reached a record $856 million in FY25, a 13% increase year-over-year.

  • Adjusted EBITDA grew 20% year-over-year to $428 million in FY25, with 500 bps margin improvement.

  • New patient starts for SUBLOCADE were up 25% year-over-year in Q4 FY25, with weekly new patient starts achieving all-time highs on three occasions.

  • The company authorized a new $400 million share repurchase program, reflecting confidence in its financial profile.

  • 2026 guidance projects 30% adjusted EBITDA growth and 13 percentage points of margin expansion to 48%.

Concerns

2

  • Total net revenue for 2026 is expected to modestly decline at the midpoint versus 2025, mainly due to anticipated U.S. SUBOXONE Film pressure, lower net revenue from the rest of the world, and continued runoff of PERSERIS.

  • Gross-to-net benefits, which served as a tailwind in 2025 (totaling $49 million for SUBLOCADE and $55 million for SUBOXONE Film), are expected to become a headwind for SUBLOCADE in 2026.

Guidance & targets

CategoryTargetConfidence
Total Net Revenue
$1.125 billion to $1.195 billion
high materiality
High
Total SUBLOCADE Net Revenue
$905 million to $945 million
high materiality
High
U.S. SUBLOCADE Dispense Unit Growth
mid-teens
high materiality
High
Non-GAAP Operating Expenses
$430 million to $450 million
medium materiality
High
Adjusted EBITDA
$535 million to $575 million
high materiality
High
Adjusted EBITDA Margin
48%
high materiality
High
Cash Flow from Operations
over $300 million
high materiality
High
Share Repurchase Program
up to $400 million
high materiality
High
Business Development Criteria
Commercial stage assets with peak sales potential >$200M, long runway (mid-to-end 2030s minimum), differentiated profile, outside OUD/SUD
medium materiality
High
SUBLOCADE Ex-U.S. Revenue
relatively flat
low materiality
Medium

Segment performance

SegmentRevenueYoYQoQMargin
SUBLOCADE
Achieved record net revenue in 2025. Strong dispense unit growth and new patient starts in Q4 2025. Market share stabilizing in the mid-70s for LAIs and new patients. Efforts focused on improving commercial execution and patient activation.
Dispense volume growth FY25: 7%Dispense volume growth Q4 FY25: 12%Dispense volume growth QoQ Q4 FY25: 6%New patient starts Q4 FY25: up 25% YoYTotal active prescribers Q4 FY25: grew 14% YoYPrescribers treating 5+ patients Q4 FY25: grew 14% YoYAccelerated second dose utilization: ~7% of new patientsHCPs prescribing accelerated second dose: 17%Commercial dispense yield productivity target: ~80%
$856M (FY25), $252M (Q4 FY25)13% (FY25), 30% (Q4 FY25)——
SUBOXONE Film
Benefited from continued generic price stability in the U.S. in FY25. Expected to face pressure in 2026.
Gross to net benefit Q4 FY25: $23MGross to net benefit FY25: $55M
————

Risks & headwinds

U.S. SUBOXONE Film pressure FY26

Expected to contribute to modest total net revenue decline in 2026

Lower net revenue from rest of the world FY26

Expected to contribute to modest total net revenue decline in 2026

Mitigation:Due to optimization conducted last year, with growth in Australia/Canada offset by Nordics volume loss.

Continued runoff of PERSERIS FY26

Expected to contribute to modest total net revenue decline in 2026

Gross-to-net dynamics FY26

Will serve as a headwind to SUBLOCADE business in 2026

What to watch in Q1 FY26

Phase II Trial Top-Line Results

Q2 2026
Current Database lock by end of Q1 2026
Target Top-line results available

Why it matters

These results will inform potential advancement of pipeline assets to late-stage clinical development.

This will be followed by a database lock by the end of the first quarter this year with the final tables, figures and listings available in the second quarter of this year for preparation of top line results on both assets.

Find out whether INDV delivers this. Inve re-checks your case every morning.

Q&A highlights

What is the peak penetration potential for LAI buprenorphine, how should investors think about SUBLOCADE's market share, and what are the therapeutic areas and criteria for future business development?

Management believes LAI penetration can reach 20-30% from the current 9%, citing analogs like schizophrenia. SUBLOCADE's market share is stabilizing in the mid-70s, with a focus on new patient share. For business development, the company seeks commercial-stage, differentiated assets outside OUD/SUD with peak sales potential over $200 million and a long runway into the mid-to-end 2030s.

“So we're looking at commercial stage only. We're looking for assets that have peak sales potential of greater than $200 million. It's important to us that the products have a long runway. One of the strengths of the Indivior story is we have a great growth driver with a durable runway in SUBLOCADE. So we want to acquire assets that have runway that goes towards the mid- to end of 2030 at a minimum. And then, of course, we want differentiated assets.”

asked by David Amsellem from Piper Sandler · answered by Joseph Ciaffoni

2 min read 6 chapters

Detailed narrative

Indivior Action Agenda Progress

The company successfully completed Phase I, "Generate Momentum," of its Indivior Action Agenda in 2025, achieving financial commitments and establishing a go-forward operating model. Key achievements included record SUBLOCADE net revenue, 20% adjusted EBITDA growth, and the elimination of a significant legacy DOJ liability. This foundation positions the company for Phase II, "Accelerate," in 2026, targeting accelerated SUBLOCADE growth and enhanced profitability.

SUBLOCADE Commercial Execution

Improved commercial execution initiatives led to strong SUBLOCADE performance in Q4 FY25, with dispense unit growth of 12% year-over-year and new patient starts up 25% year-over-year. The company exited 2025 with a record number of active prescribers, and market share for SUBLOCADE in the LAI category stabilized in the mid-70s. Efforts are focused on field force messaging, commercial channel productivity, patient activation, and policy engagement.

Direct-to-Consumer Campaign Impact

The "Move Forward in Recovery" DTC campaign, launched in October 2025, is showing encouraging early indicators of success. Prompted awareness among patients increased, branded online search volume rose 60% in Q4, and usage of the "find a provider" tool on the SUBLOCADE website increased by 70%. New CRM enrollments significantly jumped from approximately 60 to 1,400 per month, indicating strong patient engagement and intent.

Capital Deployment Strategy

Indivior outlined a three-pronged capital deployment strategy for its strong cash flow: managing debt, opportunistically deploying a newly authorized $400 million share repurchase program, and evaluating business development opportunities. The company seeks commercial-stage assets with peak sales potential over $200 million, a long runway into the mid-to-end 2030s, and differentiated profiles, specifically outside of OUD/SUD.

LAI Market Penetration

Despite SUBLOCADE's leadership, long-acting injectables remain underutilized, with current penetration at approximately 9%. Management believes there is significant opportunity for growth, citing market research supporting potential LAI penetration in the 20-30% range, similar to categories like schizophrenia. The company is committed to educating consumers and advancing policies to expand access and utilization.

Pipeline Development & R&D

The company completed two Phase II trials by the end of Q4 FY25, with database lock expected by the end of Q1 2026 and top-line results in Q2 2026. For INDV-6001, the decision to advance to Phase III will also consider manufacturing feasibility, payer-validated differentiation research, and the impact on trial design, indicating a strategic and market-focused approach to pipeline progression.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.