Earnings call transcript: Indivior Q3 2025 beats expectations, stock surges

Indivior PLC reported its third-quarter 2025 earnings, surpassing analyst expectations with an earnings per share (EPS) of $0.72 against the forecasted $0.39, marking an 84.62% surprise. Revenue also exceeded predictions, reaching $314 million compared to the expected $257.66 million, a 21.87% surprise. In response, Indivior’s stock surged 21.83% in pre-market trading, reaching $30.75.

Key Takeaways

• Indivior’s EPS and revenue significantly beat market expectations.
• The company raised its full-year 2025 revenue and EBITDA guidance.
• Indivior’s stock saw a substantial pre-market increase following the earnings report.
• SUBLOCADE continues to drive growth with a 15% year-over-year revenue increase.
• Operational restructuring led to a 32% reduction in headcount.

Company Performance

Indivior demonstrated strong performance in Q3 2025, with total net revenue rising by 2% year-over-year. The company’s flagship product, SUBLOCADE, saw a 15% increase in net revenue, contributing significantly to overall growth. Indivior maintains a dominant position in the long-acting injectable (LAI) market for opioid use disorder treatments, holding approximately 75% of the market share.

Financial Highlights

• Revenue: $314 million, up 2% year-over-year.
• Earnings per share: $0.72, significantly beating the forecast of $0.39.
• Adjusted EBITDA: $120 million, a 14% increase year-over-year.

Earnings vs. Forecast

Indivior’s Q3 2025 results exceeded expectations, with an EPS of $0.72 compared to the forecasted $0.39, representing an 84.62% surprise. Revenue also surpassed estimates, achieving $314 million against a forecast of $257.66 million, a 21.87% surprise. This performance marks a notable improvement compared to previous quarters, where earnings surprises were less pronounced.

Market Reaction

Following the earnings release, Indivior’s stock price jumped 21.83% in pre-market trading, reaching $30.75. This significant movement reflects investor optimism driven by the company’s robust financial performance and revised guidance. The stock’s current price is well above its 52-week high of $25.49, indicating strong market confidence.

Outlook & Guidance

Indivior raised its full-year 2025 total net revenue guidance to between $1.18 billion and $1.22 billion and adjusted EBITDA guidance to $400 million to $420 million. The company plans to enter "Phase Two: Accelerate" in 2026, aiming for at least $150 million in annual operating expense savings and capping the 2026 operating budget at $450 million.

Executive Commentary

"We are encouraged by our strong financial performance and improved commercial execution in the U.S.," stated Joseph Ciaffoni, CEO. Patrick Barry, CCO, highlighted the importance of the commercial channel, noting, "The commercial channel is growing and certainly Medicaid is going to be the predominant channel for us."

Risks and Challenges

• Market Penetration: The LAI market currently has an 8% penetration rate, with potential for growth but also competition.
• Operational Restructuring: While cost-saving measures are in place, the reduction in headcount could impact operations.
• Dependence on SUBLOCADE: Heavy reliance on a single product could pose risks if demand fluctuates.

Q&A

During the earnings call, analysts focused on the company’s commercial patient channel improvements and investment strategies for SUBLOCADE growth. Executives emphasized their commitment to maintaining R&D capabilities and planning for future phases of growth.

Indivior’s performance in Q3 2025 highlights its strong market position and strategic initiatives, contributing to a positive outlook among investors.

Full transcript - Indivior PLC (INDV) Q3 2025:

Sharon, Conference Call Operator: Good day and thank you for standing by. Welcome to the Indivior plc Q3 results 2025 webcast and conference call. At this time, all participants are in a listen-only mode. After the speaker’s presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one and one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one and one again. Please be advised that today’s conference is being recorded. I would now like to hand the conference over to your host for today, Jason Thompson. Please go ahead.

Jason Thompson, Investor Relations, Indivior: Thanks Sharon and welcome to Indivior’s third quarter 2025 earnings conference call. I’m joined today by Joseph Ciaffoni, Chief Executive Officer, Patrick Barry, Chief Commercial Officer, and Ryan Preblick, Chief Financial Officer. We are also joined by Christian Heidbreder, our Chief Scientific Officer, who is also available for questions. Before we begin, I need to remind everyone on today’s call that we may make forward-looking statements that are subject to risks and uncertainties and that actual results may differ materially. We list the factors that may cause our results to be materially different on slide two of this presentation. We also may refer to non-GAAP measures, the reconciliations for which may also be found in the appendix to this presentation that is now posted on our website at indivior.com. I’ll now turn the call over to Joseph Ciaffoni, our CEO.

Joseph Ciaffoni, Chief Executive Officer, Indivior: Thanks, Jason. Good morning and thank you for joining our third quarter results call. I’ll start with a brief overview of our performance in the quarter and detail the progress we are making against the Indivior Action Agenda. Pat will then discuss SUBLOCADE’s performance and the progress we are making to improve SUBLOCADE commercial execution, and Ryan will discuss our third quarter financial performance and our raised full-year 2025 guidance. We will then open the call for questions. We are encouraged by our strong financial performance and improved commercial execution in the U.S. We are making steady progress versus our priorities in Phase One Generate Momentum of the Indivior Action Agenda. We have taken several actions to simplify the organization and position Indivior for success moving forward. In the third quarter, we delivered strong 15% year-over-year growth in SUBLOCADE and benefited from continued price stability in SUBOXONE Film.

In the U.S., total net revenue grew 2% year-over-year and adjusted EBITDA was up 14%. The momentum we have generated year to date is enabling us to raise our 2025 financial guidance. We now expect total net revenue in 2025 to be up versus 2024, driven by SUBLOCADE growth of 10% at the midpoint and assumed SUBOXONE Film price stability for the remainder of the year. Adjusted EBITDA is now expected to grow 15% versus 2024 at the midpoint. I want to thank the Indivior team for their performance in the quarter and for their commitment to making a positive difference in the lives of people living with opioid use disorder in the communities that we serve.

For the rest of the year, we are focused on completing Phase One Generate Momentum of the Indivior Action Agenda, and we will be ready to enter Phase Two Accelerate on January 1, 2026. The Indivior Action Agenda is a three-phased multi-year operational roadmap intended to maximize the potential of our business and make a positive difference in the lives of people living with opioid use disorder while creating value for our shareholders. We are making steady progress in Phase One "Generate Momentum" versus our key priorities that include growing SUBLOCADE in the U.S. the remainder of the year by improving commercial execution, taking actions to simplify the organization, eliminating all nonessential activities, establishing our go forward operating model, and determining the actions and investments necessary to accelerate long-acting injectable penetration in the U.S. BMAC category and to accelerate SUBLOCADE net revenue growth in 2026 and beyond.

For our top priority, growing SUBLOCADE in the U.S., improved commercial execution was the primary driver of solid dispense unit growth. Patrick Barry will discuss our commercial progress in more detail. We also took several actions to simplify the organization, improve commercial productivity for SUBLOCADE, and strengthen our financial positions. These actions are expected to result in an annual reduction of operating expenses of at least $150 million as compared to 2025. Our 2026 operating budget will not exceed $450 million. To focus and simplify the organization in Phase One "Generate Momentum," we have completed the London Stock Exchange cancellation with Indivior now trading exclusively on the NASDAQ. We consolidated our operating footprint. We restructured our R&D and medical affairs organizations while preserving key capabilities. We announced our intention to pursue a change in domicile from the UK to the U.S.

We discontinued the sales and marketing efforts in support of OPVEE. We will continue to distribute product upon request and meet all required contractual and regulatory obligations, and we are optimizing our rest of world business to focus on Australia, Canada, France, and Germany, which generates 77% of forecasted rest of world net revenue and 94% of forecasted adjusted EBITDA while further reducing organizational complexity. With these actions, we have established our go forward operating model that we anticipate will generate immediate accretion to the bottom line and improve cash generation as we enter Phase Two "Accelerate" of the Indivior Action Agenda on January 1, 2026. We plan to provide full-year 2026 financial guidance in early January. Also, as part of Phase One, we are determining actions and investments necessary to accelerate SUBLOCADE growth in the U.S. Included in this is our new direct-to-consumer campaign, which launched on October 1.

In Phase Two Accelerate, we will be focused on accelerating U.S. SUBLOCADE growth throughout the year, and we expect to immediately accelerate profitability and cash generation at a faster rate in 2026. I am encouraged by the steady progress that we are making in Phase One Generate Momentum of the Indivior Action Agenda. I am confident that we will finish 2025 with momentum, and we are well positioned to enter Phase Two Accelerate on January 1, 2026. I will now turn the call over.

Patrick Barry, Chief Commercial Officer, Indivior: To Patrick, thank you Joe.

We are encouraged by our strong U.S. SUBLOCADE performance this quarter, which was driven by improved commercial execution. Our commercial team is dedicated to helping people living with OUD and have a strong belief in SUBLOCADE as the number one prescribed long-acting injectable in the category. To strengthen commercial execution, we have been sharpening the field force’s message delivery with higher utilization of SUBLOCADE’s core promotional materials on every call to improve overall intent to prescribe. We also are continuing to focus on improving field force call productivity to enable better reach and frequency on treatment providers. Building on our position as the clear number one LAI, we are reinforcing SUBLOCADE’s treatment benefits with prescribers, including broadening HCP awareness of SUBLOCADE’s label updates. These label updates include alternate injection sites and rapid patient induction, along with the ability to receive a second injection of SUBLOCADE at day eight.

SUBLOCADE’s rapid induction is a unique offering in the LAI category, and this clinical option for patients can help maximize the time at effective blood plasma concentration levels by accelerating the second 300 milligram dose. This option is strongly resonating with treatment providers. This improved commercial execution led to strong SUBLOCADE net revenue growth in the third quarter. Unit dispense growth was solid at 8% versus prior year and 3% versus the second quarter. Total category share of LAIs and new patient share in the U.S. for SUBLOCADE remain relatively stable at approximately 75%. We also saw 11% year-over-year growth in the number of active SUBLOCADE prescribers and 11% growth in those prescribing for five or more patients. The number of SUBLOCADE patients over the trailing 12 months also grew 5% year-over-year. These results are important early indicators of our commercial execution.

Ryan Preblick, Chief Financial Officer, Indivior: For the rest of the year, we.

Patrick Barry, Chief Commercial Officer, Indivior: Remain focused on executing Phase One of the Indivior Action Agenda for SUBLOCADE. This includes continuous improvement in commercial execution to generate prescribing momentum for the benefit of patients and identifying investments to accelerate LAI penetration in the U.S. to deliver sustained SUBLOCADE net revenue growth in 2026 and beyond. As part of the investments we are making to accelerate the growth of SUBLOCADE, we rolled out a brand new direct-to-consumer campaign. On October 1st, we launched our new campaign Move Forward in Recovery, which is designed to emotionally and authentically connect with patients and drive awareness of SUBLOCADE as a treatment option for patients struggling with moderate to severe opioid addiction.

Grounded in patient insights and shaped by research and lived experiences from patients and caregivers, its objective is to connect with patients by celebrating the everyday moments of recovery progress through emotionally rich visuals and a deeply personal narrative. It highlights the potential for growth, transformation, and the motivation to move forward for oneself, family, and community. Importantly, the campaign addresses the stigma surrounding opioid use disorder by portraying the humanity and dignity of people in recovery, shifting the narrative toward hope and possibility. This campaign is being deployed with sustained investment levels through an omnichannel approach, including national television, digital and social media, and in-office and point-of-care materials, along with a newly designed patient website. We’re pleased to have our new campaign in the marketplace that is raising awareness and educating patients on the hope and possibility of recovery.

While I’m pleased with our progress, we have several opportunities to drive further growth in U.S. SUBLOCADE. I’m confident that we will finish 2025 with momentum and accelerate U.S. SUBLOCADE growth in 2026 and beyond. I will now turn the call over to Ryan.

Ryan Preblick, Chief Financial Officer, Indivior: Thanks Pat. First I’ll discuss our third quarter financial performance, then our raised 2025 financial guidance and close on the financial impacts of our recent actions to simplify the organization. We are encouraged by our financial performance this quarter, which includes strong U.S. SUBLOCADE net revenue growth, stable SUBOXONE Film pricing, and year over year adjusted EBITDA growth. We have taken meaningful steps to strengthen the business and are on track to achieve our financial commitments and complete Phase One of the Indivior Action Agenda, Generate Momentum. Looking at the third quarter results in more detail, starting with the top line, total net revenue of $314 million increased 2% versus the prior year as SUBLOCADE net revenue more than offset expected pricing pressure on SUBOXONE Film and the continued wind down of PERSERIS. Total SUBLOCADE net revenue of $219 million increased 15% versus Q3 2023.

Dispense volume growth year over year was solid at 8%. On a sequential basis, total SUBLOCADE net revenue increased 5%, reflecting a 3% increase in dispense volume versus Q2. Q3 SUBLOCADE net revenue included a gross to net benefit of $10 million as well as a stocking benefit of $4 million. Turning to SUBOXONE Film net revenue in Q3, we benefited from continued price stability in the U.S. Q3 net revenue included a gross to net benefit of $13 million. Total non-GAAP operating expenses were $145 million in the third quarter, down 3% versus the same quarter last year. Non-GAAP SG&A was unchanged versus the year ago quarter. Non-GAAP R&D expenses decreased 11% due to the reprioritization of pipeline activities and to benefits from the restructuring of the R&D and medical affairs organizations.

Adjusted EBITDA was $120 million in the third quarter, up 14% versus the same quarter last year, driven by higher net revenue and lower operating expenses. Touching on the balance sheet, we ended the third quarter with gross cash and investments of $473 million, up from $347 million at year end. The increase in cash year to date was driven by approximately $200 million of cash flow from operations. Based on our solid performance year to date, we are raising our 2025 financial guidance. Our total net revenue guidance range is increasing to $1.18 billion to $1.22 billion. This raised guidance reflects better than expected year to date performance of SUBLOCADE and stability in U.S. SUBOXONE Film pricing. We now expect total net revenue in 2025 to be up versus 2024 at the midpoint.

For SUBLOCADE, we are raising our full-year 2025 net revenue guidance to the range of $825 million to $845 million. This represents year-over-year growth of 10% at the midpoint. We continue to see improving fundamentals for SUBLOCADE and expect to see growth on a demand basis for the remainder of this year. We are maintaining our gross margin guidance in the low to mid-80% range and expect to come in at the high end of our non-GAAP operating expense guidance of $585 million to $600 million, while our total non-GAAP operating expense guidance range is unchanged. We now expect SG&A between $510 million to $520 million, reflecting increased investment behind SUBLOCADE, and expect R&D between $75 million to $80 million, reflecting the restructuring of our R&D and medical affairs organizations.

We are raising our full-year 2025 adjusted EBITDA guidance to $400 million to $420 million, which is an increase of 15% versus 2024 at the midpoint. Turning to our actions to simplify the organization as part of Phase One of the Indivior Action Agenda, we made several strategic decisions that position us to realize at least $150 million in annual operating expense savings off the top end of our 2025 non-GAAP operating expense guidance range starting in 2026. These actions reduce operational complexity, increase our focus on growing SUBLOCADE in the U.S., and strengthen our financial position. All the actions taken as part of Phase One of the Indivior Action Agenda have resulted in non-GAAP charges of $65 million to date. These charges include severance costs, real estate consolidations, write-offs for inventory, equipment, and intangibles, as well as other termination payments and consulting costs.

The related cash impact is expected to be $40 million and will largely be paid out in the third and fourth quarters of this year. We are on track to deliver Phase One, Generate Momentum, and achieve our revised 2025 financial guidance. We are in a strong financial position as we enter Phase Two of the Indivior Action Agenda, Accelerate, beginning in 2026, during which we expect to drop significant dollars to the bottom line and accelerate cash flow generation. We plan to announce our 2026 financial guidance in early January. I’ll turn the call back over to Joe for concluding remarks.

Joseph Ciaffoni, Chief Executive Officer, Indivior: Thanks, Ryan. In conclusion, we have made significant progress on Phase One of the Indivior Action Agenda Generate Momentum. We delivered strong U.S. SUBLOCADE performance in the quarter, we improved our commercial execution, and we took several actions to simplify our organization. With our go-forward operating model in place, we are well positioned to finish 2025 with momentum and begin Phase Two of the Indivior Action Agenda Accelerate on January 1, 2026. On a final note, given the optimization of our rest of world business, I would like to take a moment to recognize and thank our colleagues outside the U.S. who are potentially impacted by this decision and who have worked so hard to ensure patients have access to our medicines. Your contributions to our mission of making a positive difference in the lives of people living with opioid use disorder are important and greatly appreciated.

We will now open the call for questions. Operator, thank you.

Sharon, Conference Call Operator: To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. We will now go to your first question. Your first question today comes from the line of Dennis Ding from Jefferies. Please go ahead.

Hi, good morning. Thanks for taking our question and congrats on the quarter. I have two for you guys. Number one, the new $150 million OpEx cuts for 2026. Can you please break down where this is coming from? How much of this was from the recent restructuring plans from your 8-K a few months ago, which I believe was all U.S. personnel? How much of the OUS optimization is factored into this $150 million number? Number two, when I look at SG&A as a percentage of revenue, it’s around $515 million this year or 43% of revenue. When I look at industry peers, it’s around 25%. To get to the peer average, that implies at least a $215 million cut in SG&A alone. Can you comment philosophically?

Where do you eventually see yourself relative to peers on SG&A spending and if your goal is to get to the peer average or perhaps even better than peers?

Joseph Ciaffoni, Chief Executive Officer, Indivior: Thank you, Dennis. Thanks for the questions and for the congratulations. I’m going to have Ryan answer the first question, and then I’ll take your second question.

Ryan Preblick, Chief Financial Officer, Indivior: Good morning. Thanks for the question. Before I get to the $150 million, I just want to make it clear that the first priority we had was to make sure we put the right resourcing and investments behind generating momentum behind SUBLOCADE. We went through the exercise of taking a look at the cost structure and the complexity in the business. What you saw was the net result here of $150 million. You can break it down into four categories. The largest category, almost half, is tied to labor. We reduced our headcount by over 32%. The second component was the reduction of all the non-essential spend through the categories and the functions of the business. There was the discontinuation of the sales and marketing of OPVEE, and also the final decision to optimize the rest of the world.

Joseph Ciaffoni, Chief Executive Officer, Indivior: Dennis, with regards to your second question, we did not approach Phase One of the Action Agenda, Generate Momentum, from a perspective of targets. What we were focused on is doing what is in the best interest of Indivior and creating value for our shareholders. We believe that starts with maximizing the SUBLOCADE opportunity in the U.S., and then what we did from there is we removed what we believe are all non-essential costs from the organization. My commitment as we go forward is we will continue to ensure that we are only investing in activities that are essential to us maximizing SUBLOCADE in the U.S. and also maximizing the opportunity for our portfolio in Canada and Australia. It is really not about targets, it is about what is right and in the best interest of Indivior and the value we can create for our shareholders.

Patrick Barry, Chief Commercial Officer, Indivior: Perfect.

Thank you so much.

Jason Thompson, Investor Relations, Indivior: Thank you.

Sharon, Conference Call Operator: Thank you. Your next question comes from the line of David Anselam from Piper Sandler. Please go ahead. Hi, good morning, this is Alex on for David. Thank you for taking our question. First one for me is you’ve talked about gaining traction in commercial patients who as we know are more profitable. Can you speak about that opportunity and also how you are balancing that with the core Medicaid population that comprises the majority of the business currently? Second question is can you help us contextualize R&D spend going forward given all the organizational changes?

Thank you.

Sure.

Joseph Ciaffoni, Chief Executive Officer, Indivior: Thanks for the questions. I’ll have Patrick take the first one and Ryan can take the second.

Patrick Barry, Chief Commercial Officer, Indivior: Yeah, no, I appreciate the question on the commercial channel and to your point, we want all channels to grow. We want Medicaid and commercial to grow. We’re certainly taking on the big effort of driving commercial volume. It starts with improved commercial execution around messaging and making sure that our customers understand the broad coverage that we have and the fact that those commercial patients in most cases, 95% of the time, will have a zero out of pocket. It continues with the important work of our working with our specialty pharmacy channel to make that as an efficient channel as Medicaid. We’re starting that work and we do anticipate that while that will take some time, we will see impact as we get into 2026. The fact is that the commercial channel is growing and certainly Medicaid is going to be the predominant channel for us.

We think commercial is a strong opportunity for us as well.

Ryan Preblick, Chief Financial Officer, Indivior: Ryan, yes. On the R&D spend, what you’re seeing there is the consolidation and streamlining of the R&D and the medical team, cost consolidations and the complexity there. As it stands right now, we are focused on the Phase Two assets and progressing them through 2025 and looking forward to the readouts in 2026. To be very clear, if they are ready to proceed into Phase Three, we do have the capabilities to make that happen.

Sharon, Conference Call Operator: Thank you. Your next question comes from the line of Chase Knickerbocker from Craig Hallum. Please go ahead.

Good morning. Thanks for taking the questions and congrats on a great quarter here. Maybe just first on SUBLOCADE guidance implies a very strong Q4. Can you just speak to if we’re starting to see a meaningful increase in willingness to prescribe from those label updates? Anything there and then just second on that on the LAI market generally, I mean clearly back to substantial growth. Do you think we’re now clearly kind of seeing the benefits of two voices out there driving market growth or just give us an update on your thoughts on the market there. As it’s apparent it’s very, very, very strong in the third quarter.

Patrick Barry, Chief Commercial Officer, Indivior: Yes.

Joseph Ciaffoni, Chief Executive Officer, Indivior: Chase, thanks for the questions. With regards to SUBLOCADE, what I believe we’re seeing is the cumulative effect of improved commercial execution right now. As we’re getting better, we’re doing better. We’re also seeing the impact of the label changes as awareness rises, playing through in the marketplace along with significant investments we’ve made in commercial throughout the year. As it pertains to LAI penetration, what I would emphasize there is we believe and have learned we’re the player that has the expertise and the resources to make the investment to create the awareness and drive the education around the category. That’s exactly what it is that we’re committed to do.

I want to be clear, as we transition to 2026 with our broad direct-to-consumer campaign, we are going to be investing beyond what it is that our models suggest that we should because we are committed to maximizing the potential of SUBLOCADE in the U.S.

Just with the.

Strength that we’re seeing, I mean, I know it’s probably too early of a question, but you know, certainly it seems like we should be thinking about SUBLOCADE next year as maintaining kind of double digit year over year growth as your guidance even implies for 2025 now. Just any thoughts you’d be willing to share there, Joe? Then just second on capital allocation, EBITDA guide was impressive. Can you just speak to how you’re thinking about capital allocation now that your balance sheet is going to be strengthening meaningfully?

Yeah. With regards to SUBLOCADE in 2026, we’ll hold on commenting on that until we give our financial guidance for 2026 in January. What I would say is we are encouraged that all the indicators in support of SUBLOCADE are pointing in the right direction. As it pertains to capital allocation, we’re going to ask people to be patient. We want the opportunity to finish Phase One of the Indivior Action Agenda along with our internal planning process to ensure we have a clear line of sight to the top line and the cash that we will be generating. Obviously, we’ll have a lot of optionality as we go forward. Thanks, Jeff.

Thank you.

Sharon, Conference Call Operator: Thank you. Your next question comes from the line of Christian Heidbreder from Stifel. Please go ahead.

Hi, good morning guys. Thanks for taking the questions first. One maybe on some more around the sort of drivers here potentially on SUBLOCADE as it relates to some topics maybe we haven’t touched a bit on for a while, particularly things like whether there’s any benefit you’re seeing on average duration of use for patients, but then also the ultimate conversion of prescription into an actual dispensed prescription. Anything to add there initially on that in terms of other drivers that could drive some growth?

Joseph Ciaffoni, Chief Executive Officer, Indivior: Christian, thanks for the question. I’m going to ask Pat to take that one.

Patrick Barry, Chief Commercial Officer, Indivior: Yeah, no, on dispensed growth we’re seeing really positive indicators. We saw 8% dispensed growth year over year and a sequential growth that was solid off of a strong quarter. We’re also pleased by the fact that some of the drivers behind that is we’re increasing our prescriber base as well as increasing those from that are committed to writing five plus, which is a good indicator of solid prescribing and adoption. Those are the indicators that we’re really, really focused on. We do believe that enhanced label is a differentiator in the marketplace because we’re the only long acting injectable monthly that has that rapid induction, and that’s resonating very well with customers.

Sorry, anything on the average duration that patients are on SUBLOCADE? Yeah.

Joseph Ciaffoni, Chief Executive Officer, Indivior: Christian, with regards to that, it comes through the work we’ll be doing through our specialty distribution in terms of conversion of patients to starts and how long they continue on treatment. That’s a work stream we kicked off, we’re digging deeply into, and we’ll comment more on that in 2026. We expect those efforts to start to have impact in 2026, and that’s one of the areas which we believe will help accelerate SUBLOCADE dispensed unit growth as we move forward.

Thanks. My second will be around clarification on the OpEx guide for 2026 in terms of the savings, certainly. Does that imply that effectively rest of world is streamlined as it will be by January 1, 2026? Just to clarify on the R&D part, does the guidance assume that those Phase Two assets progress into Phase Three, for example, with the cost of that, or is that something that may subsequently need an update?

I’ll ask Ryan to take the first question. I’ll take the second.

Ryan Preblick, Chief Financial Officer, Indivior: Yeah. Regarding the budget for next year, what we said is we will not spend more than $450 million. That includes everything. That includes our go forward model in the U.S. and in the rest of the world business.

Joseph Ciaffoni, Chief Executive Officer, Indivior: Okay. From an R&D perspective, with the changes that we’ve made, we’ve preserved the capability, if we’re fortunate enough to have programs to advance when the data reads out, to be able to do so. That would not result in an additional increase to OpEx in 2026.

Thank you. Very clear. Thanks, guys.

Sharon, Conference Call Operator: Thank you. Your next question comes from the line of Brandon Foulkes from HC Wainwright. Please go ahead.

Patrick Barry, Chief Commercial Officer, Indivior: Hi, thanks. Take my questions and congratulations on a very good quarter. Maybe just following on from an earlier question. As we look ahead to 2026 and the potential to move into Phase Three, what do you need to see from the SUBLOCADE business to move into that phase? Are you expecting the enhanced commercial focus to be running at full speed at that stage? Alternatively, how do you see the long term path to peak sales and SUBLOCADE or peak penetration in the LAI market? Along those lines, thinking again of Phase Three, what are you thinking about in terms of that breakout phase? In terms of assets you’d go after, are these adjacencies that may not distract from the SUBLOCADE efforts? Just any color on that would be helpful.

Yeah.

Joseph Ciaffoni, Chief Executive Officer, Indivior: Brandon, thank you for the congratulations and certainly appreciate the questions. First off, I want to emphasize we are head down in Phase One, Generate Momentum, and looking to finish off the year and be positioned to start Phase Two, Accelerate, on January 1st. The second thing I want to emphasize, we’ve been clear. We have to earn our way to Phase Three, and that starts with internally the confidence that we have the capabilities to take on more, and then of course externally that we have the credibility to do so. We’re not focused on Phase Three at this point; we’re focused around executing what we’re setting out to do.

I think to your question directly, when we transition to Phase Two, the answer will be, one, the assessment of the internal capabilities, which will be aligned to the results that we’re delivering relative to the guidance that we’re giving. From what we would be looking at, what I would be comfortable saying now, if we earn our way to it, will be commercial stage assets that have the potential to enhance our growth profile and to diversify our revenue. I’ll let Pat comment on long-acting injectable penetration and what it is that we’re doing to drive that.

Patrick Barry, Chief Commercial Officer, Indivior: Yeah, thanks Joe. Right now we are the market leader and we more than stabilized share at 75%, but the fact is that the overall LAI category still sits at 8%, and so our focus is going to be on continuing to improve our commercial execution. As we get better, the business will get better. We do believe that our effectiveness will drive LAI category, and we also are placing a big bet on direct-to-consumer as the category leader. We want to drive education of those OUD patients and drive traffic into our treaters’ offices, and we’re investing in that way, in a sustained way to do just that. Certainly not going to call a peak penetration rate, but I might direct you to other analogs, whether it be the HIV market or the schizophrenia market, where LAIs have achieved 20% to 25% peak penetration.

We’re a long way off from that, but that’s what’s encouraging for us. When we get better, we have a big opportunity to capitalize on.

Joseph Ciaffoni, Chief Executive Officer, Indivior: Brandon, one other thing I would add, we’ve also had Vanessa Proctor join our organization, and we believe that it’s important that the work that we do in advocating for these patients, inclusive of public policy, will be key in ensuring access and ultimately increasing long acting injectable penetration. That, along with the consumer, are really where we’re going to put our efforts to drive LAI penetration.

Sharon, Conference Call Operator: Great.

Patrick Barry, Chief Commercial Officer, Indivior: If I may follow up, and I think this may be for Ryan, it’s a bit of minutiae, but just cash flow from operations in the quarter, the one-time, is there just sort of the spend on the cost reduction and the Medicaid rebate that you called out in Q2? Anything else? Maybe just any color on cash conversion in 2026, and also, that $450 million OpEx spend, is that a cash basis or an adjusted accounting figure, which may include some non-cash figures? Sorry about the minutiae, but just want to get this right, and that’s all for me.

Ryan Preblick, Chief Financial Officer, Indivior: Thank you, Ryan.

Patrick Barry, Chief Commercial Officer, Indivior: Yes.

Ryan Preblick, Chief Financial Officer, Indivior: Starting with the 2025 cash, the $200 million is primarily driven by the underlying business. The strong demand that got us up then generate $200 million, but that was offset, as you can imagine, by some CapEx and some debt payments. That’s the walk in regards to 2025. In regards to 2026, that $450 million is our adjusted operating expense budget in terms of expense that will hit our P&L for next year.

Patrick Barry, Chief Commercial Officer, Indivior: Great, thank you very much.

Joseph Ciaffoni, Chief Executive Officer, Indivior: Thanks Brandon.

Sharon, Conference Call Operator: Thank you. Your next question comes from the line of Thibault Boutherin from Morgan Stanley. Please go ahead.

Thank you. Just maybe a quick question on SUBLOCADE in the quarter, and I apologize if it’s been touched on and I missed it, but if you could give more details on the gross to net in the quarter for SUBLOCADE. Given the guidance for the year, I assume there is no risk of reversal, but could that be a sort of bigger base when you think about growth for next year? The second question just on SUBOXONE Film, I know it’s not the focus, but just if you could touch a bit on your visibility now that we’ve seen pricing being a bit stable for more time. The erosion seems to be stable as well. That’s how you think about it in your building block when thinking about the outlook for the organization going forward.

Thank you.

Joseph Ciaffoni, Chief Executive Officer, Indivior: Thank you for the questions.

Thibaut.

I’ll take SUBOXONE and then hand the SUBLOCADE gross to net question off to Ryan. What I’ll comment on SUBOXONE is limited to 2025, which is we are at a point in the year where in our raised guidance we are not assuming any additional price erosion. That’s different than what we’ve previously said. We’re assuming price stability. We’ve also seen a relatively slow decline from a share perspective. In terms of 2026, I’m going to hold until we have a full picture of the evolution of the payer landscape and those dynamics. That certainly from a revenue perspective will be incorporated into the guidance that we give in 2026. Then Ryan on SUBLOCADE.

Ryan Preblick, Chief Financial Officer, Indivior: Yeah, so in regards to the Q3 net revenue, to give you a little color, we booked the $219 million, which was up 15% versus last year, driven primarily by the dispense. Within that number, you saw the result of our normal quarterly balance sheet review of our accruals. There was a gross and net release of $10 million in there. There was also some stocking in terms of shipment phasing. That’s the $4 million, so a total of $14 million of benefit in the quarter.

Thank you.

Jason Thompson, Investor Relations, Indivior: Thank you.

Sharon, Conference Call Operator: Thank you. I will now hand the call back to Joe for closing remarks.

Joseph Ciaffoni, Chief Executive Officer, Indivior: Thank you, operator. Thank you to everyone for joining the call today. We look forward to updating you on our progress as we execute the Indivior Action Agenda. Have a great day.

Sharon, Conference Call Operator: Thank you. This concludes today’s conference call. Thank you for participating. You may now disconnect.

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