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    INDV
    Earnings call· Dec 2025(Q4 FY25)

    Indivior Pharmaceuticals Q4 FY25 earnings call INDV

    Feb 26, 2026 Source

    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

    10
    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

    2
    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
    		————

    Operational metrics

    22
    Adjusted EBITDA
    $428Mup 20% YoY
    FY25

    Achieved with notable margin improvement.

    Adjusted EBITDA
    $142Mup 91% YoY
    Q4 FY25

    Record adjusted EBITDA for the quarter.

    Non-GAAP Operating Expenses
    $622Mdown 5% YoY
    FY25

    Driven by reductions in headcount and footprint consolidations, partially offset by increased selling and marketing investments.

    Non-GAAP Operating Expenses
    $164Mdown 8% YoY
    Q4 FY25

    Driven by reductions in headcount and footprint consolidations, partially offset by increased selling and marketing investments.

    Non-GAAP SG&A Expenses
    $545Mdown 1% YoY
    FY25

    Driven by reductions in headcount and footprint consolidations, partially offset by increased selling and marketing investments behind U.S. SUBLOCADE.

    Non-GAAP SG&A Expenses
    $148Mdown 2% YoY
    Q4 FY25

    Driven by reductions in headcount and footprint consolidations, partially offset by increased selling and marketing investments behind U.S. SUBLOCADE.

    Non-GAAP R&D Expenses
    $80Mdown 22% YoY
    FY25

    Driven by the reprioritization of pipeline activities and restructuring of R&D and medical affairs organizations.

    Non-GAAP R&D Expenses
    $17Mdown 36% YoY
    Q4 FY25

    Driven by the reprioritization of pipeline activities and restructuring of R&D and medical affairs organizations.

    Cash and Investments Balance
    $222M
    FY25

    Ended the year with this balance even after concluding the legacy DOJ matter.

    Legacy DOJ Obligation Payment
    $295M
    FY25

    Payment made to eliminate a significant future liability.

    Net Leverage
    below 1x
    FY25

    Ended the year with strong financial position.

    LAI Market Penetration
    9%
    Current

    Management believes long-acting injectables remain underutilized, with market research supporting potential penetration in the 20-30% range.

    LAI Category Growth
    approaching 18%YoY
    Q4 FY25

    Reflects strong category growth.

    Branded Online Search Volume
    increased 60%vs months prior to campaign launch
    Q4 FY25

    Following the launch of the Move Forward in Recovery DTC campaign.

    SUBLOCADE Website Find a Provider Tool Usage
    increased 70%YoY
    Q4 FY25

    Following the launch of the Move Forward in Recovery DTC campaign.

    New CRM Enrollments
    ~1,400 per monthvs ~60 per month prior to campaign
    Q4 FY25

    Reflecting meaningful intent-driven patient action following the DTC campaign.

    Simplification Action Charges
    $120M
    FY25

    Includes severance, write-offs for leases, inventory, equipment, intangibles, and other termination payments and consulting costs.

    Simplification Action Charges
    $55M
    Q4 FY25

    Includes severance, write-offs for leases, inventory, equipment, intangibles, and other termination payments and consulting costs.

    SUBLOCADE Gross to Net Benefit
    $19M
    Q4 FY25

    Due to an increase in trade inventory.

    SUBLOCADE Gross to Net Benefit
    $49M
    FY25

    Contributed to the increase in SUBLOCADE net revenue.

    SUBOXONE Film Gross to Net Benefit
    $23M
    Q4 FY25

    Contributed to SUBOXONE Film net revenue.

    SUBOXONE Film Gross to Net Benefit
    $55M
    FY25

    Contributed to SUBOXONE Film net revenue.

    Industry KPIs

    6
    MetricValueDetails
    Prescription volumemid-teens%
    EPS revenue guidance$1.125B-$1.195B (Total Net Revenue); $905M-$945M (SUBLOCADE Net Revenue)USD
    Pipeline clinical milestones2 Phase II trials
    Therapeutic drug market sharemid-70s%
    Geographic regional revenue growthrelatively flatN/A
    Business development capacity deal appetiteavailable capacityN/A

    Risks & headwinds

    4
    U.S. SUBOXONE Film pressureFY26

    Expected to contribute to modest total net revenue decline in 2026

    Lower net revenue from rest of the worldFY26

    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 PERSERISFY26

    Expected to contribute to modest total net revenue decline in 2026

    Gross-to-net dynamicsFY26

    Will serve as a headwind to SUBLOCADE business in 2026

    What to watch in Q1 FY26

    5

    Phase II Trial Top-Line Results

    Q2 2026
    CurrentDatabase lock by end of Q1 2026
    TargetTop-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.

    Q&A highlights

    5

    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 read6 chapters

    Detailed Narrative

    01

    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.

    02

    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.

    03

    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.

    04

    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.

    05

    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.

    06

    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.

    AI-generated summary of the company’s earnings call. Not investment advice.