Indivior Reports Third Quarter 2025 Financial Results and Raises Full-Year 2025 Financial Guidance

• Q3'25 Total Net Revenue of $314m, up 2% YOY; Q3'25 SUBLOCADE® Net Revenue of $219m, up 15% YOY
• Announces the Optimization of Rest of World (ROW) Business
• Discontinued the Sales and Marketing Support of OPVEE®
• Expect Annual Operating Expense Savings of at Least $150m in 2026
• On Track to Enter Phase II of the Indivior Action Agenda — Accelerate — January 1, 2026
• Conference Call Scheduled for Today at 8:00 A.M. Eastern

RICHMOND, Va., Oct. 30, 2025 /PRNewswire/ -- Indivior PLC (NASDAQ:INDV) today reported its financial results for the third quarter ended September 30, 2025, and provided a business update.

"In the third quarter, we executed on Phase I of the Indivior Action Agenda, Generate Momentum, by growing SUBLOCADE® and simplifying the business," said Joe Ciaffoni, Chief Executive Officer. "Commercial execution drove strong SUBLOCADE performance in the quarter, and we established our go-forward operating model that is expected to generate at least $150 million in annual operating expense savings beginning in 2026. We are on track to move into Phase II of the Indivior Action Agenda, Accelerate, and expect to deliver immediate accretion to the bottom line and improved cash generation beginning in January 2026."

"Strong SUBLOCADE net revenue growth and SUBOXONE® Film price stability in the U.S. led us to raise our 2025 financial guidance," said Ryan Preblick, Chief Financial Officer. "We now expect year-over-year total net revenue growth in 2025, with adjusted EBITDA expected to increase 15% year-over-year at the mid-point of our guidance ranges. The actions Indivior has taken to simplify the organization, including reducing headcount, consolidating our footprint, discontinuing commercial support of OPVEE®, optimizing the ROW business and plans to redomicile in the U.S., are expected to generate immediate accretion to adjusted EBITDA in 2026."

Business Highlights:

• Grew total SUBLOCADE Q3'25 net revenue to $219m, up 15% year-over-year and 5% versus Q2'25. Q3'25 U.S. SUBLOCADE net revenue increased 14% to $203m versus Q3'24 and 4% versus Q2'25. Growth was primarily driven by increased volume and gross-to-net benefits.
• Launched national direct-to-consumer (DTC) campaign, "Move Forward in Recovery," a new patient activation initiative anchored by a television advertisement designed to support Indivior's top priority: SUBLOCADE growth in the U.S.
• Simplified the organization as part of Phase I of the Indivior Action Agenda — Generate Momentum:
  • Initiated the optimization of the ROW business with plans to exit several non-U.S. markets, including the U.K., Ireland, Sweden, Israel, Finland and Italy. The Company will continue to own and operate its Fine Chemicals Plant in Hull, U.K. and will also continue to sell product and maintain operations in Canada, Australia and France, and sell product in Germany. These countries collectively represent 77% of forecasted ROW net revenue and 94% of forecasted ROW adjusted EBITDA.
  • Discontinued the sales and marketing support of OPVEE. Indivior will continue to distribute product upon request and meet all required contractual and regulatory obligations.
  • Restructured the R&D and Medical Affairs organizations, including the announced closure of three related locations.
  • Announced the intention to change the Company's domicile from the U.K. to the U.S. and the establishment of a new U.S. parent company, Indivior Pharmaceuticals, Inc., once the redomicile is complete.
• Expanded U.S. indexation with inclusion in the MSCI U.S. Indices (including the U.S. Small Cap Index) and the S&P Total Market Index.
• Published results from a clinical trial in JAMA Network Open that found rapid SUBLOCADE induction had higher treatment retention rates compared to standard induction, particularly among fentanyl-positive participants.

Raising 2025 Financial Guidance:

• Guidance assumes no material change in exchange rates for key currencies compared with 2024 average rates, notably USD/GBP and USD/EUR.

*See reconciliation of non-GAAP measures beginning on page 8.

Financial Results for Third Quarter Ended September 30, 2025:

• Total net revenue in Q3 increased 2% to $314m (Q3'24: $307m) at actual exchange rates (2% increase at constant exchange rates). Total SUBLOCADE Q3 net revenue was $219m, up 15% year-over-year and 5% versus Q2'25.
• U.S. net revenue in Q3 of $267m increased 2% versus Q3'24. U.S. SUBLOCADE net revenue increased 14% to $203m versus Q3'24. The increase in U.S. net revenue was primarily driven by 8% volume growth in U.S. SUBLOCADE, which more than offset the decline in SUBOXONE Film due to generic competition, the decrease in OPVEE volumes, and the discontinuation of marketing and promotion for PERSERIS in July 2024.
• ROW net revenue in Q3 increased 2% at actual exchange rates to $47m (no change at constant exchange rates). Growth in SUBLOCADE / SUBUTEX® Prolonged Release and SUBOXONE Film was partially offset by ongoing generic erosion of the legacy SUBUTEX (buprenorphine) tablet business. ROW Q3 SUBLOCADE net revenue was $16m at actual exchange rates, an increase of 21% versus Q3'24.
• Gross margin in Q3 was 73% (Q3'24: 79%). Non-GAAP gross margin in Q3 was 84% (non-GAAP Q3'24: 82%).
• SG&A expense in Q3 was $155m (Q3'24: $142m). Non-GAAP SG&A expense in Q3 of $127m was unchanged (non-GAAP Q3'24: $127m).
• R&D expense in Q3 was $33m (Q3'24: $22m). Non-GAAP R&D expense in Q3 decreased 11% to $20m (Q3'24: $22m), reflecting the refocusing of the pipeline on existing Phase 2 OUD assets (INDV-2000 and INDV-6001).
• Net income in Q3 was $42m and diluted EPS was $0.33 (Q3'24 net income $22m; diluted loss per share: $0.16). Non-GAAP net income in Q3 was $93m and non-GAAP diluted EPS was $0.72 (Q3'24 non-GAAP net income: $65m; non-GAAP diluted EPS $0.49). The increase in non-GAAP diluted EPS was primarily driven by the increase in non-GAAP net income and the reduction in shares outstanding.
• Adjusted EBITDA in Q3 increased 14% to $120m ($105m Q3'24). The increase primarily reflects increased operating leverage driven by the year-over-year increase in net revenue over a lower operating expense base.
• Cash and investments totaled $473m at the end of Q3'25, an increase of $125m compared to $347m at the end of 2024.

Conference Call and Webcast Details:

A live conference call and webcast presentation will be held on October 30, 2025, at 8:00 A.M. EDT (13:00 GMT). The details to access the conference call and webcast are below. Materials will be available on the Company's website prior to the event at www.indivior.com. 

The webcast link is: https://edge.media-server.com/mmc/p/gtkfqvez

Participants may access the presentation telephonically by registering with the following link (please cut and paste into your browser): https://register-conf.media-server.com/register/BI470cbb79a42846d5b6b180de536bbf66

(Registrants will have an option to be called back directly immediately prior to the call or be provided a call-in # with a unique pin code following their registration)

About Indivior

Indivior Pharmaceuticals works to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a human crisis to a recognized and treated chronic disease. Building on its portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior. 

Non-GAAP Financial Measures:

This announcement includes financial measures that are not defined by US GAAP, such as non-GAAP gross margin, non-GAAP selling, general and administrative expenses, non-GAAP research and development expenses, adjusted EBITDA, non-GAAP net income, and non-GAAP diluted earnings per share. These non-GAAP financial measures are not a substitute for, or superior to, results presented in accordance with US GAAP. Non-GAAP results as presented by the Company are not necessarily comparable to similarly titled measures used by other companies. As a result, these performance measures should not be considered in isolation from, or as a substitute analysis for, the Company's results as reported in accordance with US GAAP. Management performs a quantitative and qualitative assessment to determine if an item should be considered for adjustment.

Non-GAAP financial measures adjust for non-recurring items and other items representing significant expenses or income that we believe do not reflect the Company's ongoing operations or the adjustment of which may help with the comparison to prior periods. Non-recurring items and other adjustments are excluded from non-GAAP financial measures consistent with the internal reporting provided to management and the Directors. Examples of such items could include share-based compensation expense, income or restructuring and related expenses from the reconfiguration of the Company's activities and/or capital structure, impairment of current and non-current assets, gains and losses from the sale of intangible assets, certain costs arising as a result of significant and non-recurring regulatory and litigation matters, and certain tax related matters. Beginning with our Q2 2025 financial release, adjusted EBITDA replaced non-GAAP operating income as a non-GAAP measure. The Company believes adjusted EBITDA may be useful to investors to understand the Company's performance. In addition, the Company uses "Adjusted EBITDA" in its annual incentive plan in which all executive officers participate. Share-based compensation has been excluded from non-GAAP selling, general and administrative expenses, non-GAAP net income, non-GAAP diluted earnings per share and adjusted EBITDA for the current period and prior period comparatives presented.

We have not provided the forward-looking U.S. GAAP equivalents for certain forward-looking non-U.S. GAAP metrics as a result of the uncertainty and potential variability of reconciling items. Accordingly, the Company has relied upon the exception in item 10(e)(1)(i)(B) of Regulation S-K to exclude such reconciliations, as the reconciliations of these non-U.S. GAAP guidance metrics to their corresponding U.S. GAAP equivalents are not available without unreasonable effort.

Columns and rows within financial tables may not foot due to rounding. Percentages and per share data have been calculated using actual, non-rounded figures.

Important Cautionary Note Regarding Forward-Looking Statements:

This announcement contains certain statements that are forward-looking statements. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements include, among other things, express and implied statements regarding: our financial guidance including with respect to net revenue, SUBLOCADE net revenue; SUBOXONE Film net revenue, non-GAAP gross margin, non-GAAP SG&A, non-GAAP R&D expense, and Adjusted EBITDA; expected annual operation expense savings; our plan to optimize our ROW business; our plan to change our domicile to the U.S.; and other statements containing the words "believe," "anticipate," "plan," "expect," "intend," "estimate," "forecast," "strategy," "target," "guidance," "outlook," "potential," "project," "priority," "may," "will," "should," "would," "could," "can," the negatives thereof, and variations thereon and similar expressions. By their nature, forward-looking statements involve risks and uncertainties as they relate to events or circumstances that may or may not occur in the future.

Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and only express management's beliefs regarding future results or events which, by their nature, are inherently uncertain and outside of management's control or predict. Actual results may differ materially from those expressed or implied in these forward-looking statements due to a number of factors, including: lower than expected future sales of our products; greater than expected impacts from competition; unanticipated costs including the effects of potential tariffs and potential retaliatory tariffs; whether we are able to identify efficiencies and fund additional investments that we expect to generate increased revenues, and the timing of such actions;  failure to obtain necessary court and shareholder approval to change our domicile. For additional information about some of the risks and important factors that could affect our future results and financial condition, see "Important Cautionary Note Regarding Forward-looking Statements" and "Risk Factors" in Indivior's Annual Report on Form 10-K filed March 3, 2025, our Forms 10-Q filed May 1, 2025 and July 31, 2025, and our other filings with the U.S. Securities and Exchange Commission.

We have based the forward-looking statements in this report on our current expectations and beliefs concerning future events. Forward-looking statements contained in this report speak only as of the day they are made and, except as required by law, we undertake no obligation to update or revise any forward-looking statement, whether due to new information, or to reflect events or developments that occur after the date the statement was made.

 

 

 

 

We define non-GAAP gross margin % as non-GAAP gross profit divided by net revenue.

 

 

The 2025 YTD effective tax rate was 32% (2024 YTD: 21%). On a non-GAAP basis, the 2025 YTD effective tax rate was 18% (2024 YTD: 23%). We define Non-GAAP effective tax rate as Non-GAAP tax expense divided by Non-GAAP income before taxation.

 

Indivior PLC

(Amounts in millions, except per share data and percentages)

(Unaudited)

Non-GAAP diluted earnings/(loss) per share

Management believes that non-GAAP diluted earnings/(loss) per share, adjusted for the impact of non-recurring items and other adjustments after the appropriate tax amount, may provide meaningful information on underlying trends to shareholders in respect of earnings per ordinary share. Weighted average shares used in computing non-GAAP diluted earnings per share are included in the table above. A reconciliation of GAAP net income to non-GAAP net income is included above.

Adjusted EBITDA

Adjusted EBITDA is a non-GAAP financial measure that represents GAAP net income or loss adjusted to exclude interest expense, interest income, income tax expense or benefit, depreciation and amortization, as well as share-based compensation and other adjustments reflecting changes in our business that do not represent ongoing operations. Adjusted EBITDA, as used by us, may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies.

 

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