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INDIVIOR PLC (INDV)·Q2 2025 Earnings Summary

Executive Summary

  • Indivior delivered a clean top-line/EPS beat and raised FY25 guidance. Q2 revenue was $302m and non-GAAP diluted EPS $0.51, well ahead of S&P Global consensus of $241.7m and $0.25; Adjusted EBITDA was $88m, with beats driven by SUBLOCADE volume, stable U.S. Film pricing, and favorable gross-to-net/stocking dynamics . Estimates marked with * are from S&P Global.
  • Guidance raised on both revenue and profit: FY25 net revenue to $1.03–$1.08B (from $955m–$1.025B) and Adjusted EBITDA to $275–$300m (from $220–$260m), citing stronger 1H performance and U.S. Film price stability; SUBLOCADE outlook lifted to $765–$785m .
  • SUBLOCADE momentum: Q2 global SUBLOCADE revenue $209m (+9% YoY; +19% QoQ), U.S. $195m (+9% YoY; +20% QoQ); mix benefited from dispense growth and ~5% stocking and ~5% gross-to-net tailwinds; dollarized demand basis would have been $194m .
  • Strategic setup improved: LSE delisting completed (now Nasdaq-only), inclusion in Russell 2000/3000, and “Action Agenda” to simplify org/cut non-essential spend while funding U.S. SUBLOCADE growth, positioning for faster bottom-line accretion in 2026 .

What Went Well and What Went Wrong

  • What Went Well

    • SUBLOCADE execution: $209m Q2 revenue (+9% YoY; +19% QoQ), U.S. $195m (+9% YoY; +20% QoQ); fundamentals included stable ~75% LAI share in the U.S. and prescriber depth/TTM patients growing (active prescribers +14% YoY; 5+ prescribers +9%; TTM patients +7%) .
    • Margin quality and cash: Q2 GAAP gross margin 83% (non-GAAP 84%); cash and investments $538m, up $191m YTD, aided by ~$120m Medicaid rebate timing (expected to reverse in Q3) .
    • Guidance raise and clearer FY framework: FY25 revenue/EBITDA midpoints lifted by $65m/$48m with unchanged non-GAAP GM%/OpEx ranges, underscoring confidence in 2H demand and Film pricing stability .
    • Management quote: “SUBLOCADE net revenue and pricing stability in SUBOXONE Film in the U.S. drove solid results... leading us to raise our 2025 financial guidance.” — CEO Joe Ciaffoni .
  • What Went Wrong

    • Adjusted EBITDA down modestly YoY: Q2 Adj. EBITDA $88m vs $93m LY on higher U.S. SUBLOCADE marketing; non-GAAP SG&A up 21% YoY to $80m (marketing investments) .
    • U.S. Film remains a headwind medium term: Q2 benefited from price stability and slightly higher share, but management still embeds 2H pricing pressure in guidance given generic dynamics .
    • CJ System channel rebased lower: Funding gaps/choices at certain accounts pushed LAIs out of near-term budgets; mgmt sees stabilization and growth on a demand basis in 2H but CJ headwinds linger into 2025 before improving in 2026 .

Financial Results

Headline results vs prior periods and vs estimates

MetricQ2 2024Q1 2025Q2 2025 ActualQ2 2025 Consensus*
Revenue ($m)$299 $266 $302 $241.7*
Diluted EPS (GAAP)$(0.72) $0.38 $0.14
Diluted EPS (Non-GAAP)$0.48 $0.41 $0.51 $0.25*
Gross Margin (GAAP)74% 83% 83%
Gross Margin (Non-GAAP)84% 84%
Adjusted EBITDA ($m)$93 $78 $88
  • Beat/miss highlights: Revenue $302m vs $241.7m* (beat); Non-GAAP EPS $0.51 vs $0.25* (beat). Adjusted EBITDA $88m, down YoY on higher U.S. SUBLOCADE marketing .
  • Note: EBITDA estimates may not be strictly comparable to company “Adjusted EBITDA.”

Segment revenue

Segment ($m)Q2 2024Q1 2025Q2 2025
U.S. SUBLOCADE$179 $163 $195
U.S. Sublingual & other$63 $54 $52
PERSERIS$8 $4 $1
Total U.S.$255 $222 $256
Rest of World$44 $44 $46
Total Net Revenue$299 $266 $302
Total SUBLOCADE (Global)$192 $176 $209

KPIs

KPIQ2 2025
SUBLOCADE dispenses growth+6% YoY; +9% QoQ
U.S. SUBLOCADE market share~75% stable H1 2025
Active SUBLOCADE prescribers+14% YoY
HCPs with 5+ SUBLOCADE patients+9% YoY
TTM SUBLOCADE patients+7% YoY
Cash & investments$538m (incl. ~$120m Medicaid timing benefit)

Drivers and quality of earnings

  • SUBLOCADE growth was primarily volume-led; sequential uplift also reflected ~5% stocking and ~5% gross-to-net favorability; dollarized demand basis revenue would have been $194m .
  • U.S. Film outperformed expectations on price stability and slightly higher share; management still models 2H pricing pressure .
  • GAAP tax expense included HMRC settlement effects; non-GAAP tax expense was $16m (YTD non-GAAP ETR 18%) .

Guidance Changes

MetricPeriodPrevious Guidance (4/24)Current Guidance (7/31)Change
Total Net RevenueFY 2025$955m – $1,025m $1,030m – $1,080m Raised
SUBLOCADE Net RevenueFY 2025$725m – $765m $765m – $785m Raised
OPVEE Net RevenueFY 2025$10m – $15m $10m – $15m Maintained
Non-GAAP Gross MarginFY 2025Low–mid 80% Low–mid 80% Maintained
Non-GAAP SG&AFY 2025$500m – $510m (reconciled) $500m – $510m Maintained
Non-GAAP R&DFY 2025$85m – $90m $85m – $90m Maintained
Adjusted EBITDAFY 2025$220m – $260m $275m – $300m Raised

Context: CFO said midpoints increased by ~$65m (revenue) and ~$48m (Adjusted EBITDA) from original guidance .

Earnings Call Themes & Trends

TopicQ4 2024 (Q-2)Q1 2025 (Q-1)Q2 2025 (Current)Trend
U.S. SUBLOCADE executionReiterated >$1.5B peak ambition; CJ headwinds; OHS growth; competitor share stabilizing around 35% Label changes approved 2/24 (rapid initiation, sites); OHS growth offset CJ funding gaps; marketing ramp planned Action Agenda Phase I to “Generate Momentum”; prescriber base/depth rising; ~75% total share stable Improving execution, set to accelerate in 2026
CJ System (CJS) dynamicsFunding-driven volatility, expected down in 2025, renewed growth in 2026 Funding gaps persisted; rebase near-term Stability returning; focus remains; growth on demand basis assumed 2H Rebased; gradual improvement expected
SUBOXONE Film pricingGeneric pricing pressure accelerated late 2024 Guidance embeds 55% FY25 decline; potential 5th generic Q2 price stability; 2H pressure still modeled Stabilized in Q2; cautious 2H
R&D executionOUD focus; Phase II programs funded INDV-6001 LPLV Q4’25; INDV-2000 LPLV H1’26 Both studies tracking to LP/LV late 2025 (6001) and end-2026 (2000) On track; narrowed scope
Organizational simplificationCost actions >$100m; refocus on OUD SG&A down non-GAAP; further streamlining Action Agenda: simplify org, Nasdaq-only listing, Russell inclusion Simplification accelerating
Regulatory/legal/taxLegacy matters reduced; CIA obligations on track HMRC settlement impacted tax; forward cautionary notes Legal/tax noise contained

Management Commentary

  • CEO: “We are focused on… growing U.S. SUBLOCADE net revenue and simplifying the organization to generate operational momentum… committed to achieving our financial guidance for the year” .
  • CEO on 2026: “Accelerate U.S. SUBLOCADE growth and immediately accelerate profitability and cash flow generation… immediate accretion to the bottom line… in 2026” .
  • CCO: “Record second quarter net revenue performance for SUBLOCADE was driven by year-over-year dispense growth of 6%… and 9% versus the first quarter… market share remained stable at approximately 75%” .
  • CFO: “Total SUBLOCADE net revenue increased 19% [QoQ], reflecting a 9% increase in dispense volume as well as stocking and favorable gross to net dynamics of 5% each… dollarized demand basis… $194m” .
  • CFO: “We are raising our adjusted EBITDA guidance to $275m–$300m… and total net revenue to $1,030m–$1,080m” .

Q&A Highlights

  • Commercial vs Medicaid mix: INDV aims to lift commercial contribution (currently ~25% of SUBLOCADE volume despite ~60% commercial covered lives) without deprioritizing Medicaid; focus on field messaging, coverage education, and specialty pharmacy yield .
  • CJS funding: Headwinds were budget-driven (not access/competition); stability seen after Q1 formulary changes, with growth expected as funding mechanisms (e.g., 1115 waivers) operationalize .
  • SUBOXONE Film pricing: No additional July price erosion observed; guidance remains conservative (if pressure does not materialize, upside) .
  • Stocking/gross-to-net: Q2 SUBLOCADE benefitted from ~5% stocking and ~5% GTN; minimal net stocking expected for balance of year .
  • Cost structure: Management evaluating significant reductions in non-essential spend, with intent to have “everything or near everything implemented” for full-year 2026 benefit .

Estimates Context

  • Revenue: $302m vs $241.7m* consensus (beat).
  • Non-GAAP Diluted EPS: $0.51 vs $0.25* consensus (beat).
  • Adjusted EBITDA: $88m; consensus EBITDA metric not strictly comparable to company Adjusted EBITDA.
    Values marked with * retrieved from S&P Global.
Metric (Q2 2025)ActualConsensus*Surprise
Revenue ($m)$302 $241.7*+$60.3m
Primary EPS (Non-GAAP) ($)$0.51 $0.25*+$0.26

Forward context: Management raised FY25 guidance midpoints for revenue/Adjusted EBITDA by $65m/$48m, citing stronger 1H performance and U.S. Film price stabilization .

Key Takeaways for Investors

  • Strong print with clean beats and guidance raised: Revenue and non-GAAP EPS beat materially; FY25 revenue and Adjusted EBITDA lifted, de-risking 2H expectations and supporting near-term positive sentiment .
  • SUBLOCADE fundamentals intact and improving: Volume-led growth, stable ~75% U.S. share, rising prescriber depth—management is reallocating spend to sustain momentum; sequential uplift contained stocking/GTN that should normalize .
  • Transition actions should accelerate bottom-line in 2026: Cost simplification under “Action Agenda” targeted to deliver immediate accretion as initiatives complete; watch for 3Q update on cost targets .
  • Film pricing risk managed but not eliminated: Q2 stability helped, but 2H still modeled cautiously; upside if competitive pricing pressure remains muted .
  • CJS headwinds rebased; 2026 recovery likely: Funding gaps—not competition—drove declines; potential structural supports (e.g., 1115 waivers) could enable re-acceleration over the medium term .
  • Capital markets footprint aligns with U.S. focus: LSE delisting and Russell 2000/3000 inclusion broaden U.S. investor access; supports potential index-driven flows .
  • Trading lens: Near term, raised guidance and SUBLOCADE momentum are likely stock-positive catalysts; medium term, cost actions and 2026 operating leverage are pivotal to multiple expansion .

Appendix: Additional context and materials

  • Other relevant press releases in the quarter included LSE delisting (Nasdaq-only) and Russell index inclusion, and RWE demonstrating lower ED utilization with extended-release buprenorphine, supporting payer/policy discussions .

S&P Global disclaimer: Consensus/estimate values marked with * are retrieved from S&P Global.