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

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 :

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 2025

reflecting pricing stabilization across the

U.S. generic buprenorphine / naloxone

sublingual film market participants

Moderate NR decline in FY 2025 reflecting

category 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

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

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 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.

Indivior PLC

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

(Unaudited)

Condensed consolidated statements of operations

Three Months Ended

September 30,

Nine Months Ended

September 30,

2025

2024

2025

2024

Net revenue

$ 314

$ 307

$ 881

$ 889

Cost of sales

179

183

Gross profit

230

241

702

707

Selling, general and administrative

155

142

445

437

Research and development

Acquired in-process research and development

—

Litigation settlement

—

196

Other operating (income) expense, net

(1)

Operating income (loss)

181

(8)

Interest (income) 1

(6)

(5)

(16)

(18)

Interest expense 1

Income (loss) before income taxes

158

(18)

Income tax expense (benefit) 1

(5)

(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

—

Accounts receivable, net of allowances of $2 (2025) and $3 (2024)

259

254

Inventories

155

167

Prepaid expenses

Current tax receivable

Other current assets

Total current assets

922

827

Long-term investments

Property, plant and equipment, net

124

100

Operating lease right of use assets, net

Goodwill and other intangible assets, net

Deferred tax assets

285

277

Other non-current assets

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

Current portion of long-term debt

Operating lease liabilities, current

Income taxes payable

Other current liabilities

—

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

Other non-current liabilities

Total liabilities

1,623

1,652

Shareholders' deficit

Common stock, par value $0.50 per share

Issued shares: 125 (2025) and 125 (2024)

Additional paid-in capital

109

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

Amortization of right-of-use assets

Share-based compensation expense

Impairment of tangible and intangible assets

Unrealized loss on equity investments

Deferred income taxes

(8)

(30)

Acquired in-process research and development

—

Impact from foreign exchange movements

(2)

Other adjustments, net

—

Change in operating assets and liabilities

Net cash provided by operating activities

194

Cash flows from investing activities:

Purchases of property and equipment

(42)

(13)

Purchases of in-process research and development and intangible assets

(1)

Purchases of investments in debt securities

(14)

Sales and maturities of debt securities

Net cash (used in) provided by investing activities

(42)

Cash flows from financing activities:

Proceeds from the issuance of common stock

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)

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 Ended

September 30,

Nine Months Ended

September 30,

2025

2024

2025

2024

US:

SUBLOCADE*

$ 203

$ 177

$ 561

$ 524

Sublingual & other

157

188

OPVEE 1

PERSERIS 2

Total U.S.

267

261

745

757

Rest of World

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

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 Ended

September 30,

Nine Months Ended

September 30,

2025

2024

2025

2024

GAAP gross profit

$ 230

$ 241

$ 702

$ 707

Adjustments within cost of sales

Manufacturing transition

—

Discontinuation of OPVEE sales and marketing

—

Discontinuation of PERSERIS marketing and promotion

—

Adjustments in cost of sales

Non-GAAP Gross Profit

$ 263

$ 251

$ 736

$ 749

Columns may not foot due to rounding.

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

Indivior PLC

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

(Unaudited)

Three Months Ended

September 30,

Nine Months Ended

September 30,

2025

2024

2025

2024

GAAP selling, general and administrative expenses

$ 155

$ 142

$ 445

$ 437

Adjustments within SG&A

Share-based compensation

Corporate initiative transition 1

—

Discontinuation of PERSERIS marketing and promotion

—

Acquisition-related costs 2

—

U.S. listing costs

—

Less: Adjustments in selling, general and administrative expenses

Non-GAAP selling, general and administrative expenses

$ 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 Ended

September 30,

Nine Months Ended

September 30,

2025

2024

2025

2024

GAAP research and development expenses

$ 33

$ 22

$ 76

Adjustments within R&D

Corporate initiative transition 1

—

Less: Adjustments in research and development expenses

—

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 Ended

September 30,

Nine Months Ended

September 30,

2025

2024

2025

2024

GAAP tax expense (benefit)

$ (5)

$ 8

$ 50

$ (4)

Tax on non-GAAP adjustments

(19)

(20)

(26)

(66)

Tax settlement 1

(1)

—

Other tax non-GAAP adjustments

(4)

(2)

Less: Adjustments in tax expenses

(24)

(22)

(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 financing

arrangements. The settlement is not expected to impact our future tax rates.

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)

Three Months Ended

September 30,

Nine Months Ended

September 30,

2025

2024

2025

2024

GAAP net income (loss)

$ 42

$ 22

$ 108

$ (14)

Adjustments in cost of sales

Adjustments in selling, general and administrative expenses

Adjustments in research and development expenses

—

Litigation settlement expenses

—

196

Adjustments in net other operating income

—

Adjustments in interest expense 1

—

Adjustments in tax expenses

(24)

(22)

(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.

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.

Three Months Ended

September 30,

Nine Months Ended

September 30,

2025

2024

2025

2024

Net income (loss)

$ 42

$ 22

$ 108

$ (14)

Interest (income)

(6)

(5)

(16)

(18)

Interest expense

Income tax expense (benefit)

(5)

(4)

Depreciation and amortization

Share-based compensation expense

Corporate initiative transition

—

Manufacturing transition

—

Discontinuation of OPVEE sales and marketing

—

Discontinuation of PERSERIS marketing and promotion

—

Acquisition-related costs

—

U.S. listing costs

—

Legal costs/provision

—

196

Impairment of equity investment

—

Adjusted EBITDA

$ 120

$ 105

$ 286

$ 284

Columns may not foot due to rounding.

SOURCE Indivior PLC