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

Key Takeaway: Indivior PLC reported its financial results for Q3 2025, highlighting significant growth in SUBLOCADE revenue and an increase in full-year financial guidance. The company is transitioning to Phase II of its Action Agenda, which aims to enhance profitability and cash generation. CEO Joe Ciaffoni emphasized the successful execution of their business strategy, which includes operational simplifications.
Price reaction · baseline $25.24 (2025-10-29 close) · hit pre-market · 1 other INDV headline(s) in the window, move may be shared
day 0 close
+15.4%
day 1
+16.4%
day 3 · peak
+26.8%

Market Sentiment Analysis

POSITIVE FACTORS

  • Strong growth in SUBLOCADE net revenue.
  • Raised full-year 2025 financial guidance.
  • Expected annual operating expense savings of $150 million from 2026.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+35%
120-day peak, hindsight
Typical move
5.4%
average across 2 past catalysts
Lead asset
RBP-6000
Phase 3 · Opioid Use Disorder

Full Press Release Details

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:

Raising 2025 Financial Guidance:

*See reconciliation of non-GAAP measures beginning on page8.

Financial Results for Third Quarter Ended September 30, 2025:

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 atwww.indivior.com.
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 IndiviorIndivior 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. Visitwww.indivior.comto learn more. Connect with Indivior on LinkedIn by visitingwww.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.
Prior FY 2025 Guidance (7/31/25) Revised FY 2025 Guidance
Net Revenue (NR) $1,030 million to $1,080 million $1,180 million to $1,220 million
SUBLOCADE NR $765 million to $785 million $825 million to $845 million
SUBOXONE Film NR More moderated NR decline in FY 2025reflecting pricing stabilization across theU.S. generic buprenorphine / naloxonesublingual film market participants Moderate NR decline in FY 2025 reflectingcategory price stabilization
Non-GAAP Gross Margin* Low to mid-80s % range No change
Non-GAAP SG&A* $500 million to $510 million $510 million to $520 million
Non-GAAP R&D* $85 million to $90 million $75 million to $80 million
Adjusted EBITDA* $275 million to $300 million $400 million to $420 million
Indivior PLC(Amounts in millions, except per share data and percentages)(Unaudited)
Condensed consolidated statements of operations
Three Months EndedSeptember 30, Nine Months EndedSeptember 30,
2025 2024 2025 2024
Net revenue $                314 $                 307 $                881 $                 889
Cost of sales 83 66 179 183
Gross profit 230 241 702 707
Selling, general and administrative 155 142 445 437
Research and development 33 22 76 76
Acquired in-process research and development 1 1
Litigation settlement 36 1 196
Other operating (income) expense, net (1) 4 (1) 4
Operating income (loss) 43 35 181 (8)
Interest (income)1 (6) (5) (16) (18)
Interest expense1 12 11 39 28
Income (loss) before income taxes 37 30 158 (18)
Income tax expense (benefit)1 (5) 8 50 (4)
Net income (loss) $                  42 $                   22 $                108 $                (14)
1Sign convention has been revised for all periods presented
Earnings (loss) per share
Basic $0.34 $0.16 $0.87 $(0.11)
Diluted $0.33 $0.16 $0.85 $(0.11)
Columns may not foot due to rounding. Per share data has been calculated using actual, non-rounded figures.
Indivior PLC(Amounts in millions, except per share data and percentages)(Unaudited)
Condensed consolidated balance sheets
September 30,2025 December 31,2024
Assets
Current assets
Cash and cash equivalents $                        445 $                        319
Short-term investments 1
Accounts receivable, net of allowances of $2 (2025) and $3 (2024) 259 254
Inventories 155 167
Prepaid expenses 30 31
Current tax receivable 13 33
Other current assets 19 21
Total current assets 922 827
Long-term investments 28 27
Property, plant and equipment, net 124 100
Operating lease right of use assets, net 30 39
Goodwill and other intangible assets, net 2 6
Deferred tax assets 285 277
Other non-current assets 27 39
Total assets $                    1,416 $                    1,316
Liabilities and shareholders' deficit
Current liabilities
Accrued rebates and product returns $                        613 $                        562
Accounts payable and accrued expenses 215 216
Accrued litigation settlement expenses, current 106 99
Current portion of long-term debt 18 18
Operating lease liabilities, current 10 10
Income taxes payable 4 7
Other current liabilities 11
Total current liabilities 965 924
Long-term debt, less current portion 304 315
Accrued litigation settlement expenses, non-current 300 365
Operating lease liabilities, non-current 24 32
Other non-current liabilities 30 18
Total liabilities 1,623 1,652
Shareholders' deficit
Common stock, par value $0.50 per shareIssued shares: 125 (2025) and 125 (2024) 62 62
Additional paid-in capital 109 90
Share repurchase commitment (10)
Accumulated other comprehensive loss (32) (36)
Accumulated deficit (346) (443)
Total shareholders' deficit (207) (337)
Total liabilities and shareholders' deficit $                    1,416 $                    1,316
Columns may not foot due to rounding.
Indivior PLC(Amounts in millions, except per share data and percentages)(Unaudited)
Condensed consolidated statements of cash flows
Nine Months Ended September 30,
2025 2024
Cash flows from operating activities:
Net income (loss) $                    108 $                     (14)
Adjustments to reconcile net income (loss) to net cash from operating activities:
Depreciation and amortization 8 11
Amortization of right-of-use assets 7 8
Share-based compensation expense 21 18
Impairment of tangible and intangible assets 16 8
Unrealized loss on equity investments 1 7
Deferred income taxes (8) (30)
Acquired in-process research and development 1
Impact from foreign exchange movements (2) 3
Other adjustments, net 2
Change in operating assets and liabilities 42 41
Net cash provided by operating activities 194 53
Cash flows from investing activities:
Purchases of property and equipment (42) (13)
Purchases of in-process research and development and intangible assets (1) (1)
Purchases of investments in debt securities (14) (14)
Sales and maturities of debt securities 14 88
Net cash (used in) provided by investing activities (42) 61
Cash flows from financing activities:
Proceeds from the issuance of common stock 2 3
Cash paid for repurchases of common stock (11) (123)
Repayments of debt (12) (2)
Settlement of tax on equity awards (3) (20)
Net cash used in financing activities (25) (142)
Net increase (decrease) in cash and cash equivalents 128 (28)
Exchange differences (1) (1)
Cash and cash equivalents at beginning of period 319 316
Cash and cash equivalents at end of period $                    445 $                    288
Columns may not foot due to rounding.
Indivior PLC(Amounts in millions, except per share data and percentages)(Unaudited)
Selected revenue and expense information
Three Months EndedSeptember 30, Nine Months EndedSeptember 30,
2025 2024 2025 2024
US:
SUBLOCADE* $               203 $               177 $                561 $                524
Sublingual & other 51 61 157 188
OPVEE1 8 15 8 15
PERSERIS2 6 8 19 31
Total U.S. 267 261 745 757
Rest of World 47 46 137 132
Net revenue $               314 $               307 $                881 $                889
*Total SUBLOCADE net revenue $               219 $               191 $                604 $                562
Selling, general and administrative expenses:
Selling and marketing $                 62 $                 55 $                209 $                188
General and administrative 94 87 236 250
Total selling, general and administrative expenses $               155 $               142 $                445 $                437
Columns may not foot due to rounding.
1Discontinued sales and marketing support for OPVEE® during Q3 2025.
2Marketing and promotion activities for PERSERIS were discontinued in July 2024.
Reconciliation of GAAP to non-GAAP financial information
Three Months EndedSeptember 30, Nine Months EndedSeptember 30,
2025 2024 2025 2024
GAAP gross profit $                230 $                241 $                702 $                707
Adjustments within cost of sales
Manufacturing transition 2 4
Discontinuation of OPVEE sales and marketing 30 30
Discontinuation of PERSERIS marketing and promotion 10 42
Adjustments in cost of sales 33 10 34 42
Non-GAAP Gross Profit $                263 $                251 $                736 $                749
Columns may not foot due to rounding.
Indivior PLC(Amounts in millions, except per share data and percentages)(Unaudited)
Three Months EndedSeptember 30, Nine Months EndedSeptember 30,
2025 2024 2025 2024
GAAP selling, general and administrative expenses $                155 $                142 $                445 $                437
Adjustments within SG&A
Share-based compensation 6 6 21 18
Corporate initiative transition1 22 28
Discontinuation of PERSERIS marketing and promotion 9 12
Acquisition-related costs2 4
U.S. listing costs 4
Less: Adjustments in selling, general and administrative expenses 29 15 48 38
Non-GAAP selling, general and administrative expenses $                127 $                127 $                397 $                400
Columns may not foot due to rounding.
1Includes legal and consulting costs and expenses related to severance.
2Non-recurring costs related to the acquisition and integration of the aseptic manufacturing site acquired in November 2023.
Three Months EndedSeptember 30, Nine Months EndedSeptember 30,
2025 2024 2025 2024
GAAP research and development expenses $                  33 $                  22 $                  76 $                  76
Adjustments within R&D
Corporate initiative transition1 13 13
Less: Adjustments in research and development expenses 13 13
Non-GAAP research and development expenses $                  20 $                  22 $                  63 $                  76
Columns may not foot due to rounding.
1Includes expenses related to severance and impairment related to planned facility closures.
Three Months EndedSeptember 30, Nine Months EndedSeptember 30,
2025 2024 2025 2024
GAAP tax expense (benefit) $                 (5) $                    8 $                  50 $                 (4)
Tax on non-GAAP adjustments (19) (20) (26) (66)
Tax settlement1 (1) 32
Other tax non-GAAP adjustments (4) (2) (2) 3
Less: Adjustments in tax expenses (24) (22) 5 (63)
Non-GAAP tax expense $                  19 $                  31 $                  46 $                  60
Columns may not foot due to rounding.
1Reflects an HMRC settlement which became probable during the second quarter, relating to aspects of prior years' intercompany financingarrangements. The settlement is not expected to impact our future tax rates.
Indivior PLC(Amounts in millions, except per share data and percentages)(Unaudited)
Three Months EndedSeptember 30, Nine Months EndedSeptember 30,
2025 2024 2025 2024
GAAP net income (loss) $                  42 $                  22 $                108 $               (14)
Adjustments in cost of sales 33 10 34 42
Adjustments in selling, general and administrative expenses 29 15 48 38
Adjustments in research and development expenses 13 13
Litigation settlement expenses 36 1 196
Adjustments in net other operating income 5 5
Adjustments in interest expense1 4
Adjustments in tax expenses (24) (22) 5 (63)
Non-GAAP net income $                  93 $                  65 $                213 $                203
Non-GAAP diluted earnings per share $              0.72 $               0.49 $              1.68 $               1.50
Shares used in computing diluted non-GAAP earnings per share 129 133 127 135
Columns may not foot due to rounding.
1Reflects interest related to an HMRC settlement which became probable during the second quarter.
Three Months EndedSeptember 30, Nine Months EndedSeptember 30,
2025 2024 2025 2024
Net income (loss) $                  42 $                  22 $                108 $                (14)
Interest (income) (6) (5) (16) (18)
Interest expense 12 11 39 28
Income tax expense (benefit) (5) 8 50 (4)
Depreciation and amortization 2 4 8 11
Share-based compensation expense 6 6 21 18
Corporate initiative transition 35 41
Manufacturing transition 2 4
Discontinuation of OPVEE sales and marketing 30 30
Discontinuation of PERSERIS marketing and promotion 19 54
Acquisition-related costs 4
U.S. listing costs 4
Legal costs/provision 36 1 196
Impairment of equity investment 5 5
Adjusted EBITDA $                120 $                105 $                286 $                284
Columns may not foot due to rounding.

Frequently Asked Questions

What were Indivior's Q3 2025 financial results?

Indivior reported strong growth in SUBLOCADE revenue and raised its 2025 financial guidance.

What is the Indivior Action Agenda?

The Indivior Action Agenda is a strategic plan aimed at enhancing business performance and profitability.

When will Indivior's conference call take place?

The conference call is scheduled for October 30, 2025, at 8:00 A.M. EDT.

What savings does Indivior expect from its new operating model?

Indivior expects to generate at least $150 million in annual operating expense savings starting in 2026.

Last updated: Oct 30, 2025