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    INDV
    Earnings call· Mar 2026(Q1 FY26)

    Indivior Pharmaceuticals Q1 FY26 earnings call INDV

    Apr 30, 2026 Source

    Executive summary

    Indivior Pharmaceuticals Q1 FY26 — Strong SUBLOCADE Growth Drives Raised Full-Year Guidance

    Indivior Pharmaceuticals delivered a strong first quarter, driven by robust U.S. SUBLOCADE performance and improved commercial execution, leading to a significant raise in its 2026 financial guidance. The company also strategically managed its debt and returned capital to shareholders through share repurchases. While two pipeline assets were discontinued internally, the focus remains on accelerating SUBLOCADE growth and pursuing commercial-stage business development opportunities to diversify its portfolio.

    Highlights

    5

    • Total net revenue grew 19% year-over-year to $317 million.

    • Total SUBLOCADE net revenue increased 32% year-over-year to $232 million, driven by 20% dispense unit growth.

    • Adjusted EBITDA surged 112% year-over-year to $164 million, with margin improving by 23 percentage points.

    • Successfully issued $500 million convertible notes to repay debt, reducing interest rates from 9.5% to 0.625%.

    • Repurchased $125 million of shares at an average price of $31.45, with $275 million remaining on the program.

    Concerns

    3

    • INDV-6001 will not proceed to Phase III development due to manufacturing scalability and limited differentiation challenges.

    • INDV-2000 failed to meet its primary endpoint in Phase II, leading to internal discontinuation for OUD and pursuit of external business development.

    • Gross-to-net adjustments are expected to serve as a headwind for the balance of 2026.

    Guidance & targets

    10
    CategoryTargetConfidence
    Total Net Revenue
    $1.215 billion to $1.285 billion
    high materiality
    High
    SUBLOCADE Net Revenue
    $950 million to $990 million
    high materiality
    High
    Adjusted EBITDA
    $620 million to $660 million
    high materiality
    High
    Adjusted EBITDA Margin
    51%
    high materiality
    High
    Operating Expenses
    $430 million to $450 million
    medium materiality
    High
    SUBLOCADE Dispense Unit Growth
    mid-teens
    high materiality
    High
    Share Repurchase Program Remaining Authorization
    $275 million
    medium materiality
    High
    Forward Leverage
    0.8x
    medium materiality
    High
    Cash Flow from Operations
    approximately $340 million
    medium materiality
    High
    Indivior Action Agenda Phase III Entry
    on track
    high materiality
    High

    Segment performance

    3
    SegmentRevenueYoYQoQMargin
    Total Company
    Total net revenue increased 19% versus the prior year period, driven by strong SUBLOCADE net revenue growth in the U.S.
    		$317 million19%——
    SUBLOCADE (Total)
    Total SUBLOCADE net revenue increased 32% versus the prior year period.
    		$232 million32%——
    SUBLOCADE (U.S.)
    U.S. SUBLOCADE net revenue increased 33% versus the prior year, driven by dispense unit volume growth and favorable price/mix. Achieved record new patient starts and continued growth in prescribers.
    Dispense unit volume growth: 20% YoYNew patient starts: 31,800 (29% YoY increase)Total active prescribers: 19% YoY growthHCPs treating 5+ patients: 20% YoY growthAccelerated second dose adoption (new patients): 9%Accelerated second dose adoption (active HCPs): 23%Category share of LAIs: 76% (stable)300mg dose utilization: 63% of overall SUBLOCADE utilization
    		$218 million33%——

    Operational metrics

    24
    Adjusted EBITDA
    $164 million112% year-over-year increase
    Q1 FY26

    Record adjusted EBITDA generated.

    Adjusted EBITDA Margin Improvement
    23 percentage pointsyear-over-year
    Q1 FY26

    Margin improvement driven by strong performance and operating model leverage.

    SUBLOCADE Dispense Unit Growth
    20%year-over-year
    Q1 FY26

    Acceleration driven by improved commercial execution and new consumer campaign.

    SUBLOCADE New Patient Starts
    31,80029% year-over-year increase
    Q1 FY26

    Record new patient starts achieved in the quarter.

    Total U.S. SUBLOCADE Patients Treated
    191,600
    LTM Q1 FY26

    Total patients treated over the last 12 months.

    SUBLOCADE Active Prescribers Growth
    19%year-over-year
    Q1 FY26

    Record number of active SUBLOCADE prescribers.

    HCPs Treating 5+ SUBLOCADE Patients Growth
    20%year-over-year
    Q1 FY26

    Growth in healthcare professionals treating 5 or more patients.

    Accelerated Second Dose Adoption (New Patients)
    9%
    Q1 FY26

    Percentage of new patients receiving the accelerated second dose.

    Accelerated Second Dose Adoption (Active HCPs)
    23%
    Q1 FY26

    Percentage of active HCPs prescribing a second dose in line with the expanded label.

    New CRM Enrollments (DTC Campaign)
    >1,200
    monthly (Q1 FY26)

    Patient engagement remained elevated through the 'Move Forward in Recovery' DTC campaign.

    Total Engaged Consumers (DTC Campaign)
    >8,300
    since launch

    Total consumers engaged since the launch of the 'Move Forward in Recovery' campaign.

    SUBLOCADE Treatment Provider Tool Searches
    >30,000
    Q1 FY26

    Number of people who searched for a SUBLOCADE provider on the website.

    Gross-to-Net Benefit (Prior Year Release)
    $14 million
    Q1 FY26

    Benefit from a prior year release as accruals were trued up.

    Non-GAAP Operating Expenses
    $116 million21% decrease
    Q1 FY26

    Decrease primarily driven by headcount reductions, R&D/medical affairs restructuring, and footprint consolidations.

    Gross Cash and Investments
    $201 million
    Q1 FY26 end

    Cash and investments balance at the end of the quarter.

    Share Repurchase Amount Executed
    $125 million
    Q1 FY26

    Capital returned to shareholders through opportunistic share repurchases.

    Shares Repurchased
    4 million
    Q1 FY26

    Number of shares repurchased in the quarter.

    Average Share Repurchase Price
    $31.45
    Q1 FY26

    Average price paid for shares repurchased.

    Debt Repayment (Previous Term Loan)
    $333 million
    Q1 FY26

    Most of the proceeds from convertible notes offering used to repay remaining balance.

    Interest Rate Reduction
    from 9.5% to 0.625%
    Q1 FY26

    Significant reduction in interest rate following convertible notes offering.

    SUBLOCADE 300mg Dose Utilization
    63%
    Q1 FY26

    The 300mg dose continues to grow as a percentage of overall SUBLOCADE utilization.

    LAI Category Growth
    approaching 23%
    Q1 FY26

    Overall growth in the long-acting injectable category, fueled by DTC efforts.

    Oral Buprenorphine Market Growth
    grew significantlyrelative to the rate it had consistently been growing
    Q1 FY26

    Positive for long-term LAI utilization as oral buprenorphine is the start point for LAI patients.

    Prior Share Repurchases (Past 5 Years)
    $525 million
    past 5 years

    Total amount of shares bought back over the past five years.

    Industry KPIs

    5
    MetricValueDetails
    Prescription volume31,800new patient starts
    EPS revenue guidanceTotal net revenue in the range of $1.215 billion to $1.285 billion, Adjusted EBITDA for 2026 to be in the range of $620 million to $660 millionUSD
    Therapeutic drug market share76%%
    Price volume mix decomposition20% dispense unit volume growth and favorable price/mix
    Business development capacity deal appetiteup to 3x leverage

    Deals & partnerships

    1
    Alar PharmaceuticalsAmendment to license agreement for INDV-6001

    Alar Pharmaceuticals will regain development rights to INDV-6001 and commercialization rights outside of the U.S. Indivior will maintain commercial rights in the U.S.

    Risks & headwinds

    3
    INDV-6001 Development Discontinuation

    Not advancing to Phase III

    Mitigation: Alar Pharmaceuticals regains development rights; Indivior retains U.S. commercial rights if Alar succeeds.

    INDV-2000 Phase II Failure

    Did not meet primary endpoint in Phase II trial for OUD

    Mitigation: Not progressing internally for OUD; pursuing external business development opportunities for the asset, focusing on the 200mg dose and broader polysubstance use signals.

    Gross-to-Net Adjustmentsbalance of 2026

    Expected to serve as a headwind

    Mitigation: Company will continue to provide updates each quarter; Q1 saw a $14 million benefit from prior year release.

    What to watch in Q2 FY26

    5

    SUBLOCADE Dispense Unit Growth

    next quarter
    Current20% (Q1 FY26)
    TargetMid-teens (full-year 2026)

    Why it matters

    Key driver of SUBLOCADE revenue and overall company growth, indicating continued commercial execution success.

    Looking forward, we believe continuous improvement in commercial execution and our commitment to significant and sustained investment in our new direct-to-consumer campaign will accelerate U.S. SUBLOCADE dispense unit growth to the mid-teens in 2026, up from 7% in 2025.

    Q&A highlights

    5

    Can you elaborate on gross margin trends, your M&A strategy regarding therapeutic areas and asset criteria, and how accelerated second dosing for SUBLOCADE impacts patient persistence?

    Gross margins are expected to be in the mid-80s for the year, with Q1 benefiting from prior year releases and manufacturing variances. M&A focus is on commercial-stage assets with >$200M peak sales potential, differentiated, and durable growth, while being therapeutically agnostic (excluding oncology). Accelerated second dosing helps achieve early peak plasma levels, which can improve patient stabilization and potentially persistence, especially with synthetic opioids.

    “We're looking for assets that have greater than $200 million peak sales potential. We think that's relevant relative to the size of our revenue base as we seek to enhance and diversify our growth profile.”

    asked by David Amsellem, Piper Sandler · answered by Ryan Preblick

    2 min read5 chapters

    Detailed Narrative

    01

    SUBLOCADE Performance and Commercial Execution

    SUBLOCADE demonstrated strong growth in Q1 FY26, with net revenue up 32% year-over-year to $232 million and dispense units growing 20%. This acceleration was attributed to improved commercial execution, including enhanced service agreements with key specialty pharmacies, and the successful "Move Forward in Recovery" consumer campaign. These efforts drove record new patient starts of approximately 31,800, a 29% increase year-over-year, and maintained SUBLOCADE's 76% share of the LAI category in the U.S.

    02

    Pipeline Restructuring and Strategic Focus

    Indivior decided not to advance INDV-6001 into Phase III development due to manufacturing scalability and limited differentiation concerns, amending its license agreement with Alar Pharmaceuticals to retain U.S. commercial rights. The INDV-2000 program also failed to meet its primary endpoint in a Phase II trial for opioid use disorder, leading to its internal discontinuation for this indication, though external business development opportunities are being explored. These decisions reflect a strategic portfolio review to focus resources on high-potential assets.

    03

    Financial Strength and Capital Deployment

    The company reported a 112% year-over-year increase in adjusted EBITDA to $164 million, with margin improvement of 23 percentage points. This strong financial performance enabled a debt refinancing through a $500 million senior convertible notes offering, which reduced interest rates from 9.5% to 0.625%. Indivior also returned $125 million to shareholders via share repurchases at an average price of $31.45 and plans to opportunistically utilize the remaining $275 million authorization.

    04

    Raised Full-Year Guidance

    Based on the strong Q1 results and positive trends, Indivior raised its full-year 2026 financial guidance. Total net revenue is now expected to be between $1.215 billion and $1.285 billion, with SUBLOCADE net revenue projected at $950 million to $990 million. Adjusted EBITDA guidance was increased to $620 million to $660 million, representing a 51% margin, reflecting a 50% year-over-year increase at the midpoint.

    05

    Business Development Strategy

    As the company progresses towards Phase III of its Indivior Action Agenda, it is actively evaluating commercial-stage business development opportunities. The focus is on acquiring assets with greater than $200 million peak sales potential, strong differentiation, and durable growth profiles. The company expressed comfort with taking leverage up to 3x for such strategic acquisitions, emphasizing a focus on enhancing and diversifying its growth profile rather than solely pipeline assets.

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