Sign in
IP

INDIVIOR PLC (INDV)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 net revenue was $266m, down 6% year over year but in line with planning assumptions; non-GAAP diluted EPS was $0.41 and GAAP diluted EPS was $0.38 .
  • Revenue and EPS were above consensus: revenue beat by ~$25.9m and non-GAAP EPS beat by ~$0.18; SUBLOCADE NR of $176m declined 2% YoY as justice system funding gaps and mix offset OHS volume strength .
  • FY 2025 guidance was maintained: total NR $955m–$1,025m; SUBLOCADE NR $725m–$765m; non-GAAP gross margin low-to-mid-80s; non-GAAP OpEx $610m–$625m; non-GAAP operating income $185m–$225m .
  • Near-term stock catalysts: H2 SUBLOCADE growth from increased marketing and FDA-approved label changes (rapid initiation and alternative injection sites), progress operationalizing justice system funding pathways (Medicaid 1115 waivers, grants/abatement) .

What Went Well and What Went Wrong

What Went Well

  • SUBLOCADE maintained leadership with stable new patient share around 72% and experienced dual-prescriber share ~65%; management expects H2 growth as label changes and marketing investments ramp .
  • Cost actions flowing through: non-GAAP SG&A down 8% YoY to $130m and R&D down 19% to $22m; tracking to deliver >$100m gross OpEx savings in FY 2025 .
  • Cash and investments rose to $400m (+$53m QoQ), driven by operating cash flow and working capital tailwinds from delayed government rebate invoices, despite $65m litigation payments .

Quote: “Overall results in the first quarter were in line with our expectations and consistent with our full year 2025 outlook... We expect SUBLOCADE net revenue performance to improve in the second half of the year from the commercial investments we’re making and from the important label updates.” — CEO Mark Crossley .

What Went Wrong

  • SUBLOCADE NR declined modestly YoY due to justice system funding gaps and unfavorable channel/pricing mix; U.S. SUBLOCADE NR was $163m (-3% YoY) and total SUBLOCADE NR $176m (-2% YoY) .
  • Gross margin fell to 83% (from 87% YoY) largely due to favorable manufacturing variances in Q1 2024 that did not repeat .
  • SUBOXONE Film faced intensified generic competition, pushing share down to 14.8% (vs 17.5% YoY) and requiring pricing actions to maintain formulary access; management still assumes further erosion through 2025 .

Financial Results

MetricQ3 2024Q4 2024Q1 2025
Net Revenue ($USD Millions)$307 $298 $266
Gross Margin (%)82% 83% 83%
Operating Income ($USD Millions, GAAP)——$66
EBITDA ($USD Millions)$96*$62*$73*
Diluted EPS (GAAP, $)——$0.38
Diluted EPS (non-GAAP, $)$0.54*$0.3189*$0.41

Values marked with * retrieved from S&P Global.

Estimate vs Actual (consensus):

MetricQ3 2024Q4 2024Q1 2025
Revenue Consensus Mean ($USD Millions)$302.8*$259.3*$240.1*
Revenue Actual ($USD Millions)$307 $298 $266
EPS Consensus Mean ($)$0.4067*$0.26*$0.2333*
EPS Actual (non-GAAP, $)$0.54*$0.3189*$0.41

Values marked with * retrieved from S&P Global.

Highlights:

  • Q1 2025: Revenue beat by ~$25.9m; EPS beat by ~$0.18. Q4 2024: Revenue beat by ~$38.7m; EPS beat by ~$0.059. Q3 2024: Revenue beat by ~$4.2m; EPS beat by ~$0.1333.*

Segment Breakdown (Q1 2025):

SegmentQ1 2025 ($USD Millions)
U.S. SUBLOCADE$163
U.S. Sublingual & Other$54
U.S. PERSERIS$4
Total U.S.$222
Rest of World$44
Total SUBLOCADE$176
Net Revenue$266

KPIs and Market Share:

KPIQ3 2024Q4 2024Q1 2025
U.S. patients on treatment (12M rolling)166,600 ~171,000 ~170,700
SUBLOCADE U.S. units dispensed158,500 —~151,900
New patient share (SUBLOCADE)~72% ~71% ~72%
Experienced dual-prescriber share (SUBLOCADE)mid-60s% ~65% ~65%
SUBOXONE Film U.S. share of oral BMAT—~15% 14.8%

Guidance Changes

MetricPeriodPrevious Guidance (Feb 20, 2025)Current Guidance (Apr 24, 2025)Change
Total Net RevenueFY 2025$955m–$1,025m $955m–$1,025m Maintained
SUBLOCADE NRFY 2025$725m–$765m $725m–$765m Maintained
OPVEE NRFY 2025$10m–$15m (incl. ~$8m BARDA) $10m–$15m Maintained
Non-GAAP Gross MarginFY 2025Low-to-mid 80s% Low-to-mid 80s% Maintained
Non-GAAP SG&AFY 2025($525m)–($535m) ($525m)–($535m) Maintained
Non-GAAP R&DFY 2025($85m)–($90m) ($85m)–($90m) Maintained
Non-GAAP OpEx (SG&A+R&D)FY 2025$610m–$625m $610m–$625m Maintained
Non-GAAP Operating IncomeFY 2025$185m–$225m $185m–$225m Maintained
SUBOXONE Film NRFY 2025~55% decline YoY Accelerated decline from intensified generics Maintained framing

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024)Previous Mentions (Q4 2024)Current Period (Q1 2025)Trend
Justice system funding constraints (CGS)Destocking and funding variability; loss of West Coast account CGS down ~30–35% expected in 2025; mostly funding-driven Funding gaps hit Q1; modest further impact in Q2; sequential CGS improvement expected H2 Deteriorated near-term; improving H2
Competitive landscape & shareNew patient share ~72%; cohorts mid-60s New patient share ~71%; share stabilizing ~65/35 New patient share ~72%; cohorts ~65%; market stabilizing Stabilizing
SUBLOCADE label changesPDUFA Feb 7; rapid induction, alt injection sites targeted Approval expected shortly; plan to invest behind awareness FDA approved Feb 24; rapid initiation and alternative sites in label Positive
Marketing investmentsBuilding HCP/patient awareness to expand LAI category ~$50m reinvested; returns expected to ramp Q3–Q4 Early digital indicators positive; revenue impact expected H2 Building
SUBOXONE Film pricing/competitionPrice decay post 4th generic; accrual benefits in Q3 Continued erosion; potential 5th generic; ~55% NR decline in 2025 Q1 pricing actions to maintain access; additional pressure expected Q2–Q4 Deteriorating
OPVEE adoption & evidence170+ experience programs; 32 states with standing orders Expect another BARDA order; real-world evidence focus Q1 immaterial; BARDA ~$8m expected; evidence generation continues Slow build
Alternate sites of care network~1,220 locations; DEA telehealth extension Strategy to accelerate ~1,500 sites; 8 partners; expanding Expanding
Tariffs/macroNot emphasizedTariffs monitored; manageable impact within gross margin guidance Same stance reiterated Stable

Management Commentary

  • “SUBLOCADE net revenue performance… was primarily impacted by near-term justice system funding challenges… We expect SUBLOCADE net revenue performance to improve in the second half of the year from the commercial investments we’re making and from the important label updates.” — CEO Mark Crossley .
  • “Non-GAAP SG&A expenses were $130 million… down 8%… reflecting our streamlining actions…; R&D expenses decreased 19%… refocus on Phase II OUD assets.” — CFO Ryan Preblick .
  • “Rapid initiation… and alternative injection sites… mark an advancement in the treatment of OUD.” — Indivior on SUBLOCADE label approval .
  • “Cash & investments of $400m… partially offset by $65m in legal settlement payments.” — Q1 cash position .

Q&A Highlights

  • Timing and drivers of SUBLOCADE return to growth: management expects sequential CGS improvement through the year and H2 growth as label changes and marketing impact OHS; new patient share stable ~72% .
  • CGS funding dynamics and pathways: three interventions—budget reallocation, abatement/grants, Medicaid 1115 waivers (19 states approved; operationalization expected from 2026), covering >60% of LAI volume in those states .
  • SUBOXONE Film pricing: Q1 price actions to maintain access; further generic-driven erosion anticipated Q2–Q4; potential 5th generic impact already contemplated .
  • Mix, pricing, and destocking: Q1 included mid-single-digit destocking reversing Q4 stocking; pricing largely “quiet” beyond mix effects (CGS) .
  • Alternate sites of care: ~1,500 sites across 8 partners; expanding network to reduce friction for prescribers and digital pathways .

Estimates Context

  • Q1 2025 vs consensus: revenue $266m vs $240.1m*, beat; non-GAAP EPS $0.41 vs $0.2333*, beat. Prior beats in Q4 2024 (revenue $298m vs $259.3m*; EPS $0.3189 vs $0.26*) and Q3 2024 (revenue $307m vs $302.8m*; EPS $0.54 vs $0.4067*). Only three estimates contributed each period, suggesting limited coverage and potentially higher estimate volatility.*
  • Implication: Given continued SUBOXONE Film erosion and CGS funding headwinds, Street may need to raise near-term SUBLOCADE H2 assumptions to reflect label and marketing impact, while keeping FY revenue mix and margin profile aligned with guidance .

Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • Q1 execution was on plan with a clear H2 growth setup for SUBLOCADE; watch for sequential improvement in CGS and conversion from marketing investments and label changes .
  • Revenue and EPS beat consensus despite margin headwinds; continued cost discipline supports non-GAAP operating profit trajectory within guidance .
  • SUBOXONE Film headwinds persist; management already baked further pricing pressure and potential fifth generic into guidance—focus shifts to SUBLOCADE and ROW new product growth .
  • Balance sheet remains solid ($400m cash/investments) with operating cash generation and working capital tailwinds; litigation obligations are manageable within current capital allocation priorities .
  • Strategic differentiation: FDA-approved rapid initiation and alternative injection sites plus expanding alternate sites-of-care network underpin SUBLOCADE adoption; cohort/new-start shares suggest stable leadership .
  • Near-term trading lens: Positive estimate revisions likely for H2 as SUBLOCADE growth materializes; monitor CGS funding signals (waiver operationalization, grants) and marketing KPIs translating to dispenses .
  • Medium-term thesis: Category expansion opportunity remains large (LAI penetration low vs physician view), with a two-player market stabilizing and SUBLOCADE positioned as efficacy-led leader; FY 2025 is a transition year before returning to growth trajectory .
Note: All non-GAAP guidance items exclude reconciliations per Item 10(e) exception; Street consensus values are from S&P Global.