INDIVIOR PLC
For the period ended Jun 30, 2025. Filed Jul 31, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Jul 31, 2025
INDV$36.28+2.6%Stored close · as of Nov 2, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-01.
0001625297-25-000030
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-07-31.
0001625297-25-000050
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 59 previous paragraphs and 64 current paragraphs.
33 unchanged; 19 reworded; 11 added; 7 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 6 previous and 6 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (11)
Current report
For a discussion of recent developments with respect to litigation and tax settlements, see Note 12. Commitments and Contingencies and Note 3. Income Tax, respectively.
Current report
In February 2025, the Company announced the appointment of Joe Ciaffoni as Chief Executive Officer, effective May 2025, and Mark Crossley stepped down as Chief Executive Officer. During the three months ended June 30, 2025, the Company continued to strengthen its executive team through the appointment of Patrick Barry, Chief Commercial Officer and Vanessa Procter, Executive Vice President of Corporate Affairs.
Current report
In July 2025, the Company completed cancellation of its London Stock Exchange listing and now trades exclusively on Nasdaq, which aligns to the Company's capital markets footprint and a stronger focus on SUBLOCADE growth in the U.S. Effective June 30, 2025, the Company became a member of the U.S. small-cap Russell 2000® Index and the broad-market Russell 3000® Index.
Current report
Total net revenue increased by $3 million, or 1%, and decreased by $15 million, or 3%, in the three and six months ended June 30, 2025, respectively, and U.S. net revenue increased by $1 million and decreased by $18 million, or 4%, in the three and six months ended June 30, 2025, respectively, as compared to the same periods in 2024.
Current report
U.S. net revenue. The U.S. is our largest market. Rebates, discounts and returns and other offsets to gross revenues are reflected in net revenue. U.S. net revenue from SUBLOCADE increased by $17 million, or 9%, and $13 million, or 4%, in the three and six months ended June 30, 2025, respectively, as compared to the same periods in 2024, reflecting volume increases and the benefit of changes in estimate related to rebate accruals. U.S. net revenue from other products declined $16 million and $31 million in the three and six months ended June 30, 2025, reflecting the impact of increased competitive activity resulting in lower pricing and market share in the U.S. for SUBOXONE Film and the decline in PERSERIS net revenue following the decision to discontinue commercial sales support in July 2024.
Current report
Cost of sales. Cost of sales decreased by $27 million, or 34%, and $21 million, or 18%, in the three and six months ended June 30, 2025, respectively, as compared to the same periods in 2024. The decrease primarily reflects costs incurred in the 2024 periods of $41 million related to the discontinuation of marketing and promotion of PERSERIS, partially offset by a SUBLOCADE inventory write-down of $10 million in the three months ended June 30, 2025, for finished goods expected to approach expiration prior to sale.
Current report
Selling, general and administrative expenses. Selling, general and administrative expenses increased by $6 million, or 4%, anddecreased by$5 million, or 2%, in the three and six months ended
Current report
In July 2025, legislation commonly referred to as the One Big Beautiful Bill Act was enacted, introducing amendments to U.S. tax laws with various effective dates from 2025 to 2027, primarily impacting companies domiciled in the U.S. The Company is evaluating the implications of these tax law changes and does not currently anticipate significant impacts.
Current report
Regulatory Uncertainties
Current report
The budget reconciliation legislation of 2025, One Big Beautiful Bill Act (the “OBBBA”), was signed into law in July 2025. The OBBBA contains a variety of provisions that could impact our business and results of operations, and States, Medicaid plans and providers may respond to policy and sector change by limiting patient eligibility and care delivery in ways that affect access to treatment for OUD, including:
Current report
innovative or higher cost treatments could be deprioritized or removed from states formularies, changes to Medicaid funding and eligibility rules, including more frequent redeterminations for beneficiaries receiving coverage through Medicaid, and a requirement for adults made eligible under the ACA to meet work or community engagement standards (from which persons with substance use disorder are exempt); changes to federal requirements regarding Medicaid state directed payments and provider taxes; and establishes a new rural health transformation program, among other provisions. Additional federal and state guidance is expected to be issued in order to implement these OBBBA provisions, most of which have effective dates in 2027 and 2028. Additionally, in June 2025, CMS finalized the Marketplace Integrity and Affordability Regulation which modifies the ACA exchange open enrollment periods and eligibility for premium tax credits among other requirements.
Removed paragraphs (7)
Previous report
SUBLOCADE Label Update
Previous report
On February 24, 2025, the FDA approved label changes for SUBLOCADE, including a rapid initiation protocol and alternative injection sites, marking a significant advancement in the treatment of moderate to severe opioid use disorder (OUD). Key SUBLOCADE label changes include:
Previous report
•Rapid initiation Protocol: Healthcare providers can now initiate treatment with SUBLOCADE after a single dose of transmucosal buprenorphine and a one-hour observation period to confirm tolerability. In addition, the second injection of SUBLOCADE may be administered as early as one week after the first injection.
Previous report
•Alternative Injection Sites: SUBLOCADE can now be administered subcutaneously in the abdomen, thigh, buttock, or back of the upper arm, offering patients and healthcare providers increased flexibility in treatment administration.
Previous report
Total net revenue decreased by $18 million, or 6%, to $266 million in the three months ended March 31, 2025 from $284 million in the prior year period and U.S. net revenue decreased by 8% to $222 million as compared to $241 million. The decrease was primarily driven by increased competitive activity resulting in lower pricing and market share in the U.S. for SUBOXONE Film, as well as the July 2024 discontinuation of marketing and promotion for PERSERIS.
Previous report
U.S. net revenue. Sales in the U.S. are the largest contributor to our net revenue. Sales rebates, discounts and returns and other offsets to gross revenues are reflected in net revenue. The decrease in U.S. net revenue was primarily driven by a decline in SUBOXONE Film revenue driven by intensified generic competition, which resulted in lower oral BMAT market share and lower pricing, which we expect to continue. Lower U.S. net revenue from SUBLOCADE, which decreased by $4 million, or 3%, from the three months ended March 31, 2024, reflected volume growth in the organized health system (OHS) channel that was more than offset by an expected volume decline from the justice system channel and unfavorable pricing and channel mix, which we expect to continue into the second half of 2025. In the three months ended March 31, 2025, total net revenue from PERSERIS declined to $4 million, reflecting the discontinuation of marketing and promotion of this product in the second half of 2024.
Previous report
Cost of sales. Cost of sales increased by $6 million, or 16%, to $44 million in the three months ended March 31, 2025 from $38 million in the three months ended March 31, 2024. The increase primarily reflects favorable manufacturing variances related to SUBLOCADE production that occurred in the first and second quarters of the prior year that did not recur in the current period.
Reworded paragraphs (19)
Previous wording
The following discussion of our financial condition and results of operations should be read in conjunction with the unaudited condensed consolidated financial statements included in Part I, Item 1 of this quarterly report on Form 10-Q and with our audited consolidated financial statements, including the accompanying notes, and Management's Discussion and Analysis of Financial Condition and Results of Operations, included in our Annual Report on Form 10-K for the year ended December 31, 2024. As discussed in Note 13. Revision of Previously Issued Financial Statements, the Company revised its previously issued financial statements to correct an accrual overstatement that did not have a material impact for any of the prior quarters or the annual periods in which they occurred. Amounts included in the discussion below for thethree months ended March 31, 2024 reflect the revisions.
Current wording
The following discussion of our financial condition and results of operations should be read in conjunction with the unaudited condensed consolidated financial statements included in Part I, Item 1 of this quarterly report on Form 10-Q and with our audited consolidated financial statements, including the accompanying notes, and Management's Discussion and Analysis of Financial Condition and Results of Operations, included in our Annual Report on Form 10-K for the year ended December 31, 2024. As discussed in Note 13. Revision of Previously Issued Financial Statements, the Company revised its previously issued financial statements to correct an accrual overstatement that did not have a material impact for any of the prior quarters or the annual periods in which they occurred. Amounts included in the discussion below for thethree and six months ended June 30, 2024 reflect the revisions.
Previous wording
For the periods presented, the Company operated as one business segment, which is predominantly the development, manufacture and sale of buprenorphine-based prescription drugs for the treatment of opioid dependence and related disorders, and nalmefene nasal spray for emergency opioid overdose reversal. Substantially all our net revenue was derived from sales of SUBLOCADE and other buprenorphine-based sublingual products (including SUBOXONE Film and SUBOXONE Tablet). SUBLOCADE accounted for 66% and 63% of our net revenue for the three months ended March 31, 2025, and 2024, respectively. Other buprenorphine-based sublingual products accounted for 32% and 33% of our net revenue for the three months ended March 31, 2025, and 2024, respectively. In the U.S., SUBOXONE Film had an oral buprenorphine medically assisted treatment (BMAT) average share of 14.8% and 17.5% in the three months ended March 31, 2025, and 2024, respectively, according to data from IQVIA.
Current wording
For the periods presented, the Company operated as one business segment, which is predominantly the development, manufacture and sale of buprenorphine-based prescription drugs for the treatment of opioid dependence and related disorders, and nalmefene nasal spray for emergency opioid overdose reversal. Substantially all our net revenue was derived from sales of SUBLOCADE and other buprenorphine-based sublingual products (including SUBOXONE Film, SUBOXONE Tablet and SUBUTEX Tablet). SUBLOCADE accounted for 69% and 68% of our net revenue for the three and six months ended June 30, 2025, respectively, and 64% and 64% for the three and six months ended June 30, 2024, respectively. Other buprenorphine-based sublingual products accounted for 27% and 29% of our net revenue for the three and six months ended June 30, 2025, respectively, and 31% and 32% for the three and six months ended June 30, 2024, respectively. In the U.S., SUBOXONE Film had an oral buprenorphine medically assisted treatment (BMAT) average share of 14.4% and 16.3% in the three months ended June 30, 2025 and 2024, respectively, according to data from IQVIA.
Previous wording
Net revenue for the three months ended March 31, 2025 and 2024 was driven by sales of SUBLOCADE and other buprenorphine-based sublingual products (including SUBOXONE Film and SUBOXONE Tablet).
Current wording
Net revenue for the three and six months ended June 30, 2025 and 2024 was driven by sales of SUBLOCADE and other buprenorphine-based sublingual products (including SUBOXONE Film and SUBOXONE Tablet).
Previous wording
Rest of the World net revenue. In the three months ended March 31, 2025, net revenue attributable to Rest of the World increased by 3% to $44 million as compared to $42 million in the three months ended March 31, 2024, as positive contributions from newer products (SUBLOCADE / SUBUTEX® Prolonged Release and SUBOXONE Film) were partially offset by ongoing generic erosion of the legacy tablet business. In the three months ended March 31, 2025 and 2024, SUBLOCADE / SUBUTEX Prolonged Release net revenue in Rest of World was $13 million and $12 million, respectively. We expect incremental growth from new products to continue to at least offset the decline in the legacy tablet business in 2025.
Current wording
Rest of the World net revenue. In the three and six months ended June 30, 2025, net revenue attributable to Rest of the World increased by $2 million, or 5%, and$3 million, or 4%, respectively, as compared to the same periods in 2024, reflecting positive contributions from newer products (SUBLOCADE / SUBUTEX® Prolonged Release and SUBOXONE Film) that were partially offset by ongoing generic erosion of the legacy tablet business. In the three and six months ended June 30, 2025, SUBLOCADE / SUBUTEX Prolonged Release net revenue in Rest of World was $14 million and $27 million, respectively, as compared to $13 million and$25 million for the same periods in 2024, respectively. We expect incremental growth from new products to continue to at least offset the decline in the legacy tablet business in 2025.
Previous wording
The following table provides a summary of activities with respect to accrued rebates and product returns and prompt pay discounts for the three months ended March 31, 2025:
Current wording
The following table provides a summary of activities with respect to accrued rebates and product returns and prompt pay discounts for the six months ended June 30, 2025:
Previous wording
Accrued rebates and product returns include chargebacks as these are paid by Indivior. Prompt pay discounts are recorded as offsets to accounts receivable as of March 31, 2025. Accrued rebates and product returns and prompt pay discounts increased to $678 million as of March 31, 2025 from $560 million as of December 31, 2024, primarily as a result of a delay in payment of government rebates due to late receipt of invoices. We expect rebate payments to increase in the second quarter.
Current wording
Accrued rebates and product returns include chargebacks as these are paid by Indivior. Prompt pay discounts are recorded as offsets to accounts receivable as of June 30, 2025. Accrued rebates and product returns and prompt pay discounts increased to $712 million as of June 30, 2025 from $592 million as of June 30, 2024, primarily as a result of the timing of payment of government rebates due to late receipt and processing of invoices. The processing time also favorably impacted our cash balance at June 30, 2025. We expect rebate payments to increase in the third quarter and the accrual balance to revert to levels more in line with those at the 2024 year-end.
Previous wording
Gross margin, which we define as gross profit divided by net revenue, was 83% in the three months ended March 31, 2025 as compared to 87% in the three months ended March 31, 2024. The decrease primarily reflects the favorable manufacturing variances related to the production of SUBLOCADE in the prior period that did not recur in the current period. We expect gross margin to continue in the low-to-mid 80 percent range for the remainder of 2025.
Current wording
Gross margin, which we define as gross profit divided by net revenue, was 83% and 83% in the three and six months ended June 30, 2025, respectively, as compared to 74% and 80% in the same periods in 2024, respectively. The increase primarily reflects costs of $41 million in the 2024 periods related to the discontinuation of marketing and promotion of PERSERIS. We expect gross margin to continue in the low-to-mid 80 percent range for the remainder of 2025.
Previous wording
Selling, general and administrative expenses. Selling, general and administrative expenses decreased by $11 million, or 8%, to $132 million in the three months ended March 31, 2025 from $143 million in the three months ended March 31, 2024. Lower expenses primarily reflect benefits from streamlining actions taken in 2024, including narrowing the Company's commercial focus on OUD treatments and discontinuing marketing and promotion of PERSERIS. General and administrative expenses for the three months ended March 31, 2025 also benefited from a one-time, low-to-mid single-digit change in estimate related to Indivior's share of the Branded Fee.
Current wording
June 30, 2025, respectively, as compared to the same periods in 2024. Higher expenses in the three months ended June 30, 2025 reflect a $14 million increase in marketing, primarily for U.S. SUBLOCADE, partly offset by lower general and administrative expenses driven by streamlining actions taken in 2024, including narrowing the Company's commercial focus on OUD treatments and discontinuing marketing and promotion of PERSERIS. For thesix months ended June 30, 2025, excluding the benefit of aone-time change in estimate related to Indivior's share of the Branded Fee, lower selling, general and administrative expenses benefited from the streamlining actions described above.
Previous wording
Research and development expenses. Research and development expenses decreased by $5 million, or 19%, to $22 million in the three months ended March 31, 2025 from $28 million in the three months ended March 31, 2024, primarily reflecting the Company's actions to refocus its development pipeline on the Phase 2 OUD assets (INDV-2000 and INDV-6001). We expect research and development expenses to continue to track below 2024 levels throughout 2025.
Current wording
Research and development expenses. Research and development expenses decreased by $5 million, or 20%, and $11 million, or 20%, in the three and six months ended June 30, 2025, respectively, as compared to the same periods in 2024, primarily reflecting the Company's actions to refocus its development pipeline on the Phase 2 OUD assets (INDV-2000 and INDV-6001). We expect research and development expenses to continue to track below 2024 levels throughout 2025.
Previous wording
Net interest expense. Net interest expense was $7 million in the three months ended March 31, 2025 as compared to net interest expense of $2 million in the three months ended March 31, 2024. The increase in net interest expense reflected the interest expense of the larger amount borrowed under the Company's new borrowing arrangement secured in late 2024 as well as a decrease in interest income on lower investment balances.
Current wording
Net interest expense. Net interest expense was $10 million and $17 million in the three and six months ended June 30, 2025, respectively, as compared to net interest expense of $3 million and $5 million in the three and six months ended June 30, 2024. Higher net interest expense in the 2025 periods includes $4 million related to an expected U.K. tax settlement and reflected interest expense on the larger amount borrowed under the Company's new borrowing arrangement secured in late 2024 as well as a decrease in interest income on lower investment balances.
Previous wording
Income tax expense. Income tax expense was $11 million in the three months ended March 31, 2025 as compared to $11 million in the three months ended March 31, 2024, resulting in an effective tax rate of 19% and 16%, respectively. Both periods benefited from U.K. innovation deductions and intragroup financing transactions; however, in the three months ended March 31, 2025 this benefit was partially offset by a U.K. global minimum top-up tax. In the three months ended March 31, 2024, the Company recognized a share-compensation excess tax benefit.
Current wording
Income tax expense (benefit). Income tax expense of $44 million and $56 million in the three and six months ended June 30, 2025, respectively, as compared to income tax benefit of $23 million and $12 million in the three and six months ended June 30, 2024, resulted in an effective tax rate of 71% and 46% in the three and six months ended June 30, 2025, respectively. Both periods benefited from intragroup financing transactions; however, in the three and six months ended June 30, 2025 this benefit was fully offset by a tax reserve for an HMRC settlement which became probable during the quarter and a U.K. global minimum top-up tax. The HMRC settlement relates to aspects of prior years' intercompany financing arrangements and is not expected to impact our future tax rates. In the three and six months ended June 30, 2024, the Company recognized a share-compensation excess tax benefit.
Previous wording
Many risks and uncertainties are discussed in the Risk Factors section in Item 1A of our Annual Report on Form 10-K filed March 3, 2025, as updated in Part II Item 2 of this report, which we incorporate by reference herein. In addition to that discussion, we note uncertainties regarding how recent tariff actions by the U.S. federal government may impact our revenues. Also, we note that approximately 85% of our revenues are derived from sales within in the U.S. and all of our key products, chiefly SUBLOCADE, OPVEE and SUBOXONE Film are manufactured primarily in the U.S. However, it remains unclear whether the tariffs will apply to raw materials and work in process which are part of our pharmaceutical manufacturing process, and whether tariffs apply to intellectual property owned by our U.K. subsidiary and licensed to other members of our group, including our U.S. subsidiary. Additionally, we do not know whether other countries will impose retaliatory tariffs that may impact the sale of our products and our margins outside of the United States.
Current wording
Many risks and uncertainties are discussed in the Risk Factors section in Item 1A of our Annual Report on Form 10-K filed March 3, 2025 and Quarterly Report on Form 10-Q filed May 1, 2025, which we incorporate by reference herein. In addition to that discussion, we note continuing uncertainty regarding U.S. federal government tariffs, and changes thereto, may impact our revenues. Also, we note that approximately 85% of our revenues are derived from sales within in the U.S. and all of our key products, chiefly SUBLOCADE, OPVEE and SUBOXONE Film are manufactured primarily in the U.S. However, it remains unclear whether the tariffs will apply to raw materials and work in process which are part of our pharmaceutical manufacturing process, and whether tariffs apply to intellectual property owned by our U.K. subsidiary and licensed to other members of our group, including our U.S. subsidiary. Additionally, we do not know whether other countries will impose retaliatory tariffs that may impact the sale of our products and our margins outside of the United States.
Previous wording
Net cash provided by operating activities was $75 million during the three months ended March 31, 2025, an increase of $112 million, compared to net cash used in operating activities of $37 million in the three months ended March 31, 2024. Net cash provided by operations in the three months ended March 31, 2025 benefited from the timing of receipt of approximately $100 million in government rebate invoices. Both periods reflected scheduled payment of litigation settlements. Refer to Item 1. Financial Statements—Note 7. Accrued Litigation Settlement Expenses for additional details.
Current wording
Net cash provided by operating activities was $233 million and $51 million during the six months ended June 30, 2025 and 2024, respectively, an increase of net cash provided of $182 million. Net cash provided by operating activities in the six months ended June 30, 2025 reflected higher cash generated from operations and benefited from timing of receipt and processing of approximately $120 million in government rebate invoices, most of which were paid in July 2025.
Previous wording
Net cash used in investing activities was $5 million in the three months ended March 31, 2025, a decrease of $30 million, compared to net cash provided by investing activities of $25 million in the three months ended March 31, 2024. The change reflects lower maturities of investments, partly offset by an increase in capital expenditures.
Current wording
Net cash used in investing activities was $22 million and net cash provided by investing activities was $26 million in the six months ended June 30, 2025 and 2024, respectively, a decrease of net cash provided of $49 million. The change reflects lower proceeds from maturities of investments, partly offset by an increase in capital expenditures.
Previous wording
We expect approximately $50 million to $70 million of capital expenditures in 2025, primarily to finalize the SUBLOCADE suite at the Raleigh Manufacturing Facility, after which time we expect capital expenditures to revert to levels more in line with Indivior’s history.
Current wording
We expect approximately $50 million to $70 million of capital expenditures for the full year 2025, primarily to finalize the SUBLOCADE suite at the Raleigh Manufacturing Facility, after which time we expect capital expenditures to revert to levels more in line with Indivior’s history.
Previous wording
The Company expects to continue investing in development stage assets from time to time, with no current commitments.
Current wording
The Company expects to continue evaluating investment opportunities in commercial and development stage assets, with no current commitments.
Previous wording
Net cash used in financing activities decreased by $39 million, from $56 million in the three months ended March 31, 2024 to $17 million in the three months ended March 31, 2025. Net cash used in financing activities in the current period primarily reflects lower cash outflows for shares repurchased and canceled and the settlement of tax on equity awards partially offset by higher scheduled amortization payments under the Company's new debt facility. In 2025, the annual scheduled amortization is 5% of the original gross loan balance.
Current wording
Net cash used in financing activities decreased by $70 million in the six months ended June 30, 2025. Net cash used in financing activities in the current period primarily reflects lower cash outflows for shares repurchased and canceled and the settlement of tax on equity awards, partially offset by higher scheduled amortization payments under the Company's new debt facility. In 2025, the annual scheduled amortization is 5% of the original gross loan balance.
Previous wording
Our current liabilities exceed our current assets by$122 million and total liabilities exceed our total assets by$285 million. The Company could sustain negative working capital because of the timing of rebate payments relative to the collection of accounts receivable.
Current wording
Our current liabilities exceed our current assets by$106 million and total liabilities exceed our total assets by$257 million. The Company sustains negative working capital because of the timing of rebate payments relative to the collection of accounts receivable.
Previous wording
INDV-2000 (Selective OREXIN-1 Receptor Antagonist): For the Phase 2 proof of concept study, the first subject first visit was achieved on June 10, 2024. The estimated last subject last visit is now expected in the first half of 2026 (previously late 2025). The delay is due to a lower than expected conversion rate from subject screening to study enrollment.
Current wording
INDV-2000 (Selective OREXIN-1 Receptor Antagonist): For the Phase 2 proof of concept study, the first subject first visit was achieved on June 10, 2024. The estimated last subject last visit is currently expected in late 2025.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Both periods reflected scheduled payment of litigation settlements. Refer to Item 1. Financial Statements—Note 7. Accrued Litigation Settlement Expenses for additional details.