Executive Summary

Q3 2025 delivered a clean beat and guidance raise: revenue $314m (+2% YoY; +4% QoQ) and non-GAAP diluted EPS $0.72, both ahead of S&P Global consensus; management lifted FY25 revenue to $1.18–$1.22B and adjusted EBITDA to $400–$420m . Revenue consensus for Q3 was ~$261.9m* and EPS consensus ~$0.412*, implying meaningful beats.
SUBLOCADE strength drove the print: $219m (+15% YoY; +5% QoQ), with U.S. net revenue $203m (+14% YoY), aided by 8% YoY/3% QoQ dispense growth, DTC launch, and label updates that enable rapid initiation and earlier second injection .
Non-GAAP gross margin of 84% expanded YoY, but GAAP gross margin fell to 73% on restructuring/portfolio actions (notably $30m OPVEE sales/marketing discontinuation flowed through COGS) as simplification progresses toward ≥$150m 2026 opex savings and a U.S. redomicile .
Stock catalysts: sustained SUBLOCADE outperformance (volume, GTN), FY25 raise with potential 2026 opex ceiling ≤$450m and intensified U.S. DTC, plus U.S. redomicile/ROW optimization that may unlock indexation and simplify governance .

What Went Well and What Went Wrong

What Went Well
- SUBLOCADE delivered: $219m (+15% YoY; +5% QoQ), with U.S. $203m (+14% YoY), driven by dispense growth and gross-to-net tailwinds; management cited improved field execution and label updates (rapid induction; earlier second injection) .
- FY25 guidance raised across top line and profit: revenue to $1.18–$1.22B; SUBLOCADE to $825–$845m; adjusted EBITDA to $400–$420m; non-GAAP R&D lowered to $75–$80m .
- Operating model simplification on track: discontinued OPVEE sales/marketing support, ROW optimization (exit several markets), U.S. domicile pursuit, and ≥$150m opex savings expected in 2026 .
What Went Wrong
- GAAP gross margin compression to 73% (vs. 79% LY) driven by portfolio/transition costs (incl. $30m OPVEE discontinuation costs in COGS) despite non-GAAP GM of 84% .
- GAAP SG&A rose to $155m (from $142m) on corporate transition costs; non-GAAP SG&A flat at $127m, indicating investment needs to sustain SUBLOCADE momentum while simplification savings ramp .
- SUBOXONE Film remains a secular headwind (generic erosion), though pricing was stable in Q3; ROW legacy SUBUTEX tablets continue to erode, offsetting newer product growth .

Financial Results

Headline results vs estimates (S&P Global) – Q1–Q3 2025

Metric	Q1 2025	Q2 2025	Q3 2025
Revenue (Actual, $m)	$266	$302	$314
Revenue Consensus Mean ($m)*	$240.1*	$241.7*	$261.9*
Beat/(Miss) ($m)	+$25.9	+$60.3	+$52.1
Non-GAAP Diluted EPS (Actual)	$0.41	$0.51	$0.72
EPS Consensus Mean*	$0.233*	$0.250*	$0.412*
Beat/(Miss)	+$0.177	+$0.260	+$0.308

Values retrieved from S&P Global.*

Quarterly P&L snapshot and margins

Metric	Q3 2024	Q1 2025	Q2 2025	Q3 2025
Revenue ($m)	$307	$266	$302	$314
GAAP Diluted EPS	$0.16	$0.38	$0.14	$0.33
Non-GAAP Diluted EPS	$0.49	$0.41	$0.51	$0.72
GAAP Gross Margin	79%	83%	83%	73%
Non-GAAP Gross Margin	82%	—	84%	84%
Adjusted EBITDA ($m)	$105	$78	$88	$120

Segment/product revenue detail ($m)

Metric	Q3 2024	Q2 2025	Q3 2025
SUBLOCADE (Total)	$191	$209	$219
U.S. SUBLOCADE	$177	$195	$203
U.S. Sublingual & other	$61	$52	$51
U.S. OPVEE	$15	—	$8
U.S. PERSERIS	$8	$8	$6
Total U.S.	$261	$256	$267
Rest of World	$46	$46	$47
Total Revenue	$307	$302	$314

KPIs (SUBLOCADE franchise execution)

KPI	Q3 2024	Q2 2025	Q3 2025
Dispenses (000s)	158.5	165.7	171.5
QoQ / YoY Growth	—	+9% QoQ	+3% QoQ / +8% YoY
TTM Patients	166,628	—	174,674 (+5% YoY)
Prescriber Base	7,687	—	8,568 (+11% YoY)
HCPs with 5+ patients	3,047	—	3,375 (+11% YoY)

Notes on non-GAAP adjustments: Q3 non-GAAP GM of 84% adds back $33m in COGS (incl. $30m related to OPVEE discontinuation) and other transition items; non-GAAP SG&A backs out $29m (incl. $22m corporate transition) and R&D backs out $13m of severance/impairment .

Guidance Changes

Metric	Period	Previous (7/31/25)	Current (10/30/25)	Change
Total Net Revenue	FY 2025	$1,030–$1,080m	$1,180–$1,220m	Raised
SUBLOCADE Net Revenue	FY 2025	$765–$785m	$825–$845m	Raised
Non-GAAP Gross Margin	FY 2025	Low–mid 80%	Low–mid 80%	Maintained
Non-GAAP Operating Expenses	FY 2025	$585–$600m	$585–$600m	Maintained
Non-GAAP SG&A	FY 2025	$500–$510m	$510–$520m	Slightly higher (SUBLOCADE investment)
Non-GAAP R&D	FY 2025	$85–$90m	$75–$80m	Lowered
Adjusted EBITDA	FY 2025	$275–$300m	$400–$420m	Raised
2026 Opex Framework	FY 2026	—	≤$450m total opex (≥$150m savings)	New clarity

Earnings Call Themes & Trends

Topic	Q-2 (Q1 2025)	Q-1 (Q2 2025)	Current (Q3 2025)	Trend
SUBLOCADE commercial execution	Justice channel funding headwinds; OHS growth; guidance unchanged	Dispense +9% QoQ; U.S. SUBLOCADE $195m; GTN/stocking benefits; marketing stepped up	Dispense +3% QoQ/+8% YoY; label update traction; DTC launched Oct 1; U.S. $203m	Improving momentum
Pricing/mix – SUBOXONE Film	Competitive pressure; share 14.8%	U.S. price stability in 1H25	Assuming price stability through FY25	Stabilizing near-term
Cost actions/simplification	>$100m gross opex savings in FY25 targeted	Action Agenda launched; LSE delisting; index inclusions	Discontinued OPVEE sales/marketing; ROW optimization; ≥$150m 2026 savings; U.S. redomicile	Accelerating
Non-GAAP profile	Non-GAAP SG&A down; EPS $0.41	Non-GAAP GM 84%; Adj. EBITDA $88m	Non-GAAP GM 84%; Adj. EBITDA $120m	Expanding leverage
R&D focus	INDV-2000/6001; INDV-2000 P2 readout pushed to H1’26	R&D $21m; focused pipeline	Non-GAAP R&D down to $20m; P2 programs continue	Leaner, focused
Regulatory/label	SUBLOCADE label update (rapid initiation; earlier 2nd dose; new sites)	—	Continued physician education; JAMA Open rapid induction evidence	Supportive
Capital markets/corporate	—	Russell indexation; LSE delist	U.S. redomicile plan and timeline	U.S.-centric

Management Commentary

CEO: “Commercial execution drove strong SUBLOCADE performance… expected to generate at least $150 million in annual operating expense savings beginning in 2026… expect to deliver immediate accretion to the bottom line and improved cash generation beginning in January 2026.” .
CFO: “Q3 SUBLOCADE net revenue included a gross-to-net benefit of $10 million as well as a stocking benefit of $4 million… We are raising our 2025 financial guidance… adjusted EBITDA to $400–$420 million.” .
CCO: “SUBLOCADE’s rapid induction is a unique offering… unit dispense growth was solid at 8% versus prior year and 3% versus the second quarter… prescriber base +11% YoY; HCPs with 5+ patients +11% YoY.” .
On cost program: “We reduced headcount by over 32%… discontinuation of OPVEE sales/marketing, optimization of ROW… largest savings tied to labor.” .

Q&A Highlights

OpEx program breakdown: ~half of ≥$150m 2026 savings from labor (headcount down >32%); remainder from non-essential spend, OPVEE exit, and ROW optimization .
Channel strategy: pushing commercial-payer growth while maintaining Medicaid leadership; 95% of commercial patients have $0 OOP; improving specialty pharmacy yield; visible impact into 2026 .
R&D cadence: streamlined org; phase 2 programs continue; company retains ability to move to phase 3 without lifting 2026 opex above ≤$450m .
Gross-to-net and shipment phasing: Q3 included ~$10m GTN release and ~$4m stocking benefit within SUBLOCADE .
SUBOXONE outlook: FY25 assumes price stability; 2026 view deferred pending payer landscape update .
Capital allocation: management prioritizes completing Phase I and clarity on 2026 cash before detailing capital deployment .

Estimates Context

Q3 2025 results materially exceeded S&P Global consensus: revenue $314m vs ~$261.9m* and non-GAAP EPS $0.72 vs ~$0.412*; Q2 and Q1 also topped revenue and EPS consensus by wide margins, reflecting accelerating execution and mix benefits.*
Street models likely need to adjust FY25/26 for: raised FY25 revenue/EBITDA, higher SUBLOCADE run-rate and DTC leverage, non-GAAP GM durability, and a structurally lower 2026 opex base (≤$450m) supporting operating leverage .