Q4 2025 Indivior PLC Earnings Call

February 26, 2026

Jason Thompson: Good day. Thank you for standing by. Welcome to Indivior Pharmaceuticals Inc.'s Q4 and full year 2025 Results Conference Call and Webcast. 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, please press star one one on your telephone. You will hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please note that today's conference is being recorded. I would now like to hand the conference over to Jason Thompson, your host for today's call. Please go ahead.

Speaker #1: At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. To ask a question during the session, please press star 11 on your telephone.

Speaker #1: You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please note that today's conference is being recorded.

Speaker #1: I would now like to end the conference over to Jason Thompson, your host, for today's call. Please go ahead.

Jason Thompson: Thank you, good morning, everyone. I am joined today by Joe Ciaffoni, Chief Executive Officer, Patrick Barry, Chief Commercial Officer, and Ryan Preblick, Chief Financial Officer. We're also joined by Christian Heidbreder, our Chief Scientific Officer. Before we begin, I need to remind everyone that on today's call, 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 here 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 Joe Ciaffoni, our CEO.

Speaker #2: Thank you and good morning, everyone. I am joined today by Joseph Ciaffoni, Chief Executive Officer; Pat Barry, Chief Commercial Officer; and Ryan Preblick, Chief Financial Officer.

Speaker #2: We're also joined by Christian Heidbreder, our Chief Scientific Officer. Before we begin, I need to remind everyone that on today's call, we may make forward-looking statements that are subject to risks and uncertainties, and that actual results may differ materially.

Speaker #2: We list the factors that may cause our results to be materially different here on slide 2 of this presentation. We also may refer to non-GAAP measures that reconciliations for which may also be found in the appendix to this presentation that is now posted on our website at INDIVIOR.com.

Speaker #2: I'll now turn the call over to Joseph Ciaffoni, our CEO.

Speaker #3: Thanks, Jason. And good morning, and thank you for joining us on today's call to review our fourth quarter and full year 2025 results. I will begin with an overview of our business performance in 2025 and summarize our progress against the INDIVIOR Action Agenda.

Joe Ciaffoni: Thanks, Jason. Good morning and thank you for joining us on today's call to review our Q4 and full year 2025 results. I will begin with an overview of our business performance in 2025 and summarize our progress against the Indivior Action Agenda. Pat will provide a commercial update and discuss our priorities for SUBLOCADE. Finally, Ryan will review our financial performance, 2026 guidance, and detail our capital deployment strategy. 2025 was a transition year for the company. Last July, we rolled out the Indivior Action Agenda to maximize the potential of our business, make a positive difference in the lives of people living with opioid use disorder, and to create value for our shareholders. We've made significant progress, including successfully completing Phase I, Generate Momentum, and delivering against our financial commitments for 2025.

Speaker #3: Pat will then provide a commercial update and discuss our priorities for Sublicate. Finally, Ryan will review our financial performance 2026 guidance and then detail our capital deployment strategy.

Speaker #3: 2025 was a transition year for the company. Last July, we rolled out the INDIVIOR Action Agenda to maximize the potential of our business, make a positive difference in the lives of people living with opioid use disorder, and to create value for our shareholders.

Speaker #3: We've made significant progress, including successfully completing Phase 1, Generate Momentum, and delivering against our financial commitments for 2025. Specifically, we improved our commercial execution and generated momentum for SUBLOCADE.

Joe Ciaffoni: Specifically, we improved our commercial execution and generated momentum for SUBLOCADE, delivering re-record net revenue in 2025 of $856 million, a 13% increase versus 2024, and total net revenue of $1.24 billion, representing a 4% increase compared to the prior year. We took several actions to simplify our organization and establish Indivior's go-forward operating model. Operating expenses will not exceed $450 million in 2026. We grew adjusted EBITDA 20% year-over-year to $428 million in 2025, along with notable margin improvement. We launched a new direct-to-consumer campaign, Move Forward in Recovery, on 1 October 2025, to drive awareness of SUBLOCADE among people living with opioid use disorder.

Speaker #3: Delivering record net revenue in 2025 of $856 million, a 13% increase versus 2024, and total net revenue of $1.24 billion, representing a 4% increase compared to the prior year.

Speaker #3: We took several actions to simplify our organization and establish INDIVIOR's go-forward operating model. Operating expenses will not exceed $450 million in 2026. We grew adjusted EBITDA 20% year over year to $428 million in 2025, along with notable margin improvement.

Speaker #3: We launched a new direct-to-consumer campaign, Move Forward and Recovery, on October 1, 2025, to drive awareness of Sublicate among people living with opioid use disorder.

Speaker #3: Although early, we are encouraged by the engagement we are seeing and all key leading indicators are trending ahead of expectations. Finally, we strengthened our financial profile, including paying the outstanding $295 million obligation related to the legacy DOJ matter, thereby eliminating a significant future liability for our company.

Joe Ciaffoni: Although early, we are encouraged by the engagement we are seeing, and all key leading indicators are trending ahead of expectations. Finally, we strengthened our financial profile, including paying the outstanding $295 million obligation related to the legacy DOJ matter, thereby eliminating a significant future liability for our company. I want to thank the Indivior team for their contributions to our progress against the Indivior Action Agenda and their unwavering dedication to people living with opioid use disorder in the communities we serve. Our strong financial performance and the momentum we generated in 2025 position us to Accelerate in 2026. Our confidence in the business is reinforced by our new $400 million share repurchase program, authorized by our board that we announced this morning.

Speaker #3: I want to thank the Indivior team for their contributions to our progress against the Indivior Action Agenda and their unwavering dedication to people living with opioid use disorder in the communities we serve.

Speaker #3: Our strong financial performance and the momentum we generated in 2025 position us to accelerate in 2026. Our confidence in the business is reinforced by our new $400 million share repurchase program authorized by our board that we announced this morning.

Speaker #3: With Phase 1 of the INDIVIOR Action Agenda completed and our go-forward operating model firmly established, we are now executing on Phase 2 of the INDIVIOR Action Agenda accelerate.

Joe Ciaffoni: With Phase I of the Indivior Action Agenda completed and our go-forward operating model firmly established, we are now executing on Phase II of the Indivior Action Agenda, Accelerate. During this phase, we expect to accelerate SUBLOCADE dispense unit growth and net revenue throughout 2026 and immediately grow adjusted EBITDA and cash flow at a faster rate. SUBLOCADE is the first and number one prescribed long-acting injectable for the treatment of moderate to severe opioid use disorder. It is the only monthly long-acting injectable with an indication for rapid initiation and has been prescribed to over 475,000 people. We believe that SUBLOCADE is a durable growth driver with 12 Orange Book-listed patents that range from 2031 to 2038. We are committed to investing at sustained levels to maximize the potential of SUBLOCADE and grow the long-acting injectable market.

Speaker #3: During this phase, we expect to accelerate Sublicate dispense unit growth and net revenue throughout 2026 and immediately grow adjusted EBITDA and cash flow at a faster rate.

Speaker #3: Sublicate is the first and number one prescribed long-acting injectable for the treatment of moderate to severe opioid use disorder. It is the only monthly long-acting injectable with an indication for rapid initiation and has been prescribed to over 475,000 people.

Speaker #3: We believe that Sublicate is a durable growth driver with 12 orange book-listed patents that range from 2031 to 2038. We are committed to investing at sustained levels to maximize the potential of Sublicate, and grow the long-acting injectable market.

Speaker #3: Although we are making progress, we believe long-acting injectables remain underutilized. We expect our laser focus on improving commercial execution, our sustained investments in patient education and activation, and efforts to advance state and federal policies that support greater treatment access will drive the acceleration of Sublicate.

Joe Ciaffoni: Although we are making progress, we believe long-acting injectables remain underutilized. We expect our laser focus on improving commercial execution, our sustained investments in patient education and activation, and efforts to advance state and federal policies that support greater treatment access will drive the acceleration of SUBLOCADE. I am encouraged by the trends we are seeing across all key metrics thus far in Q1. In 2026, we expect to deliver SUBLOCADE dispense unit growth in the mid-teens, an acceleration compared to the 7% dispense unit growth we achieved in 2025. This will result in SUBLOCADE net revenue growth of 8% at the midpoint of our guidance range. The leverage generated by our go-forward operating model will immediately accelerate adjusted EBITDA and cash flow at a faster rate.

Speaker #3: I am encouraged by the trends we are seeing across all key metrics thus far in the first quarter. In 2026, we expect to deliver SUBLOCADE dispense unit growth in the mid-teens and acceleration compared to the 7% dispense unit growth we achieved in 2025.

Speaker #3: This will result in Sublicate net revenue growth of 8% at the midpoint of our guidance range. The leverage generated by our go-forward operating model will immediately accelerate adjusted EBITDA and cash flow at a faster rate.

Speaker #3: We expect to generate 30% adjusted EBITDA growth in 2026, representing a 13 percentage point improvement in our adjusted EBITDA margin compared to 2025, and we expect to generate approximately $300 million in cash flow from operations.

Joe Ciaffoni: We expect to generate 30% adjusted EBITDA growth in 2026, representing a 13 percentage point improvement in our adjusted EBITDA margin compared to 2025, and we expect to generate approximately $300 million in cash flow from operations. Our increased cash flow and strong financial position will enable us to strategically deploy capital to create value for our shareholders. Our capital deployment priorities are threefold: manage our debt, opportunistically deploy our newly authorized $400 million share repurchase program, and evaluate potential business development opportunities to acquire the next commercial stage growth drivers as we earn our way to phase III of the Indivior Action Agenda, Breakout. We are encouraged by, but not satisfied with, the progress we made in 2025.

Speaker #3: Our increased cash flow and strong financial position will enable us to strategically deploy capital to create value for our shareholders. Our capital deployment priorities are threefold.

Speaker #3: Manage our debt, opportunistically deploy our newly authorized $400 million share repurchase program, and evaluate potential business development opportunities to acquire the next commercial-stage growth drivers as we earn our way to Phase 3 of the INDIVIOR Action Agenda breakout.

Speaker #3: We are encouraged by, but not satisfied with, the progress we made in 2025. The actions we took and the foundation we established strongly position us to achieve our financial and operational objectives in Phase 2 accelerate in 2026.

Joe Ciaffoni: The actions we took and the foundation we established strongly position us to achieve our financial and operational objectives in Phase II, Accelerate, in 2026. I'll now turn the call over to Pat.

Speaker #3: I'll now turn the call over to Pat.

Speaker #2: Thanks, Joe. And good morning, everyone. As part of Phase 1 of the INDIVIOR Action Agenda, Generate Momentum, we have been focused on improving commercial execution for Sublicate.

Patrick Barry: Thanks, Joe, and good morning, everyone. As part of Phase I of the Indivior Action Agenda, Generate Momentum, we have been focused on improving commercial execution for SUBLOCADE. Our commercial team is dedicated to helping people living with OUD, and they have a strong belief in SUBLOCADE as the first and number one prescribed long-acting injectable in the category. We have made progress on our commercial execution initiatives, which are reflected in our Q4 and full year results. In the Q4, we delivered strong dispense unit growth of 12% versus the prior year and 6% versus the Q3. New patient starts in the Q4 were up 25% year-over-year, and over the course of the last 10 weeks of the year, weekly new patient starts achieved all-time highs on three separate occasions.

Speaker #2: Our commercial team is dedicated to helping people living with OUD, and they have a strong belief in Sublicate as the first and number one prescribed long-acting injectable in the category.

Speaker #2: We have made progress on our commercial execution initiatives, which are reflected in our fourth-quarter and full-year results. In the fourth quarter, we delivered strong dispense unit growth of 12% versus the prior year, and 6% versus the third quarter.

Speaker #2: New patient starts in the fourth quarter were up 25% year over year, and over the course of the last 10 weeks of the year, weekly new patient starts achieved all-time highs on three separate occasions.

Speaker #2: Total category share of LAIs and new patient share in the US for Sublocade continues to stabilize in the mid-70s. We exited 2025 with a record number of active Sublocade prescribers, including those treating five or more patients.

Patrick Barry: Total category share of LAIs and new patient share in the US for SUBLOCADE continued to stabilize in the mid-70s. We exited 2025 with a record number of active SUBLOCADE prescribers, including those treating 5 or more patients. In Q4, both total active SUBLOCADE prescribers and prescribers treating 5 or more patients grew 14% year-over-year and approximately 6% sequentially. We believe this progress represents a combination of the fundamental strengths of SUBLOCADE, along with our improving commercial execution. We are encouraged by the momentum we generated exiting 2025, and are well positioned to Accelerate in 2026. We remain focused on continuous improvement in commercial execution to accelerate SUBLOCADE prescribing volume for the benefit of people living with OUD.

Speaker #2: In the fourth quarter, both total active Sublicate prescribers and prescribers treating five or more patients grew 14% year over year and approximately 6% sequentially.

Speaker #2: We believe this progress represents a combination of the fundamental strengths of Sublicate, along with our improving commercial execution. We are encouraged by the momentum we generated exiting 2025 and are well positioned to accelerate in 2026.

Speaker #2: We remain focused on continuous improvement in commercial execution to accelerate Sublicate prescribing volume for the benefit of people living with OUD. Our efforts are centered on driving excellence and field force messaging, improving commercial channel productivity, growing patient activation and new starts, and unlocking treatment access through proactive engagement with policy leaders.

Patrick Barry: Our efforts are centered on driving excellence and field force messaging, improving commercial channel productivity, growing patient activation and new starts, and unlocking treatment access through proactive engagement with policy leaders. We have seen improvements across each of these areas. Our field force messaging acumen that is focused on SUBLOCADE's differentiated label, is driving growth in the number of physicians utilizing the accelerated second dose. Approximately 7% of new patients received the accelerated second dose, and 17% of active HCPs prescribed a second dose in line with the expanded SUBLOCADE label. On commercial dispense yield productivity, we remain in the early stages of improving yields towards our non-commercial channel average of approximately 80%. We are seeing steady progress with our targeted commercial specialty pharmacies and expect steady yield improvement as we move through 2026.

Speaker #2: We have seen improvements across each of these areas. Our field force messaging acumen that is focused on Sublicate's differentiated label is driving growth in the number of physicians utilizing the accelerated second dose.

Speaker #2: Approximately 7% of new patients receive the accelerated second dose, and 17% of active HCPs prescribe a second dose in line with the expanded Sublicate label.

Speaker #2: On commercial dispense yield productivity, we remain in the early stages of improving yields towards our non-commercial channel average of approximately 80%. We are seeing steady progress with our targeted commercial specialty pharmacies and expect steady yield improvement as we move through 2026.

Speaker #2: In addition to these commercial improvement initiatives, we are investing to expand patient awareness and engagement. Last October, we launched our direct-to-consumer campaign, Move Forward and Recovery, which is designed to emotionally and authentically connect with people living with OUD and drive awareness of Sublicate as a treatment option for those struggling with moderate to severe opioid addiction.

Patrick Barry: In addition to these commercial improvement initiatives, we are investing to expand patient awareness and engagement. Last October, we launched our direct-to-consumer campaign, Move Forward in Recovery, which is designed to emotionally and authentically connect with people living with OUD and drive awareness of SUBLOCADE as a treatment option for those struggling with moderate to severe opioid addiction. Recall, this campaign has an omni-channel approach, including national television, digital and social media, and in-office point-of-care materials, along with a newly designed SUBLOCADE patient website. We are seeing early indicators of success following the launch of the campaign. For example, prompted awareness among patients has increased versus the Q1 of 2025.

Speaker #2: Recall this campaign has an omnichannel approach including national television, digital, and social media and in-office point-of-care materials, along with a newly designed Sublicate patient website.

Speaker #2: We are seeing early indicators of success following the launch of the campaign. For example, prompted awareness among patients has increased versus the first quarter of 2025.

Speaker #2: Branded online search volume increased 60% in the fourth quarter compared to the months immediately prior to the launch of the campaign, driving high-quality engagement on the Sublicate website including a 70% increase in usage of the Find a Sublicate treatment provider tool.

Patrick Barry: Branded online search volume increased 60% in Q4 compared to the months immediately prior to the launch of the campaign, driving high quality engagement on the SUBLOCADE website, including a 70% increase in usage of the Find a SUBLOCADE Treatment Provider tool. We also saw an average of around 1,400 new CRM enrollments per month in Q4, versus around 60 per month immediately prior to the new campaign, reflecting meaningful and tenure-driven patient action. We are also actively pursuing opportunities to expand patient access through our proactive public policy initiatives. For example, in several states, long-acting injectables are only available under a medical benefit. This creates logistical complexity, upfront costs, and administrative burden for providers. Expanding coverage under a pharmacy benefit would reduce these barriers, lower financial risk, and improve provider adoption.

Speaker #2: We also saw an average of around 1,400 new CRM enrollments per month in the fourth quarter, versus around 60 per month immediately prior to the new campaign, reflecting meaningful and tent-driven patient action.

Speaker #2: We are also actively pursuing opportunities to expand patient access through our proactive public policy initiatives. For example, in several states, long-acting injectables are only available under a medical benefit.

Speaker #2: This creates logistical complexity, upfront cost, and administrative burden for providers. Expanding coverage under a pharmacy benefit would reduce these barriers, lower financial risk, and improve provider adoption.

Patrick Barry: In parallel, we are engaging on bundled payment structures to help ensure that long-acting injectables are appropriately recognized, whether through potential carve-outs or a more accurate reflection in overall payment levels. This would strengthen the financial viability of treating people with OUD. Taken together, our improving commercial execution, patient activation efforts, and policy initiatives are laying the foundation for SUBLOCADE acceleration and give us confidence in our ability to deliver mid-teen dispense unit growth in 2026. I will now turn the call over to Ryan.

Speaker #2: In parallel, we are engaging on bundle payment structures to help ensure that long-acting injectables are appropriately recognized whether through potential carve-outs or a more accurate reflection in overall payment levels.

Speaker #2: This would strengthen the financial viability of treating people with OUD. Taken together, our improving commercial execution, patient activation efforts, and policy initiatives are laying the foundation for Sublicate acceleration and give us confidence in our ability to deliver mid-teens dispense unit growth in 2026.

Speaker #2: I will now turn the call over to Ryan.

Speaker #3: Thanks, Pat. And good morning. First, I'll highlight our fourth-quarter and full-year financial performance, followed by a review of our 2026 guidance, and close on our capital deployment strategy.

Ryan Preblick: Thanks, Pat. Good morning. First, I'll highlight our Q4 and full year financial performance, followed by a review of our 2026 guidance, and close on our capital deployment strategy. We delivered on our financial commitments in 2025. We grew total SUBLOCADE net revenue by 13% and adjusted EBITDA by 20% year-over-year, and we simplified the organization while strengthening our financial profile. We are well positioned to execute on phase II of the Indivior Action Agenda, Accelerate. Looking at our results in more detail, starting with the top line. Total net revenue of $358 million for Q4 and approximately $1.24 billion for the full year, increased 20% and 4% respectively, versus the prior year periods. The increase for both periods was driven by strong SUBLOCADE net revenue growth.

Speaker #3: We delivered on our financial commitment in 2025. We grew total Sublicate net revenue by 13% and adjusted EBITDA by 20% year over year. And we simplified the organization while strengthening our financial profile.

Speaker #3: We are well positioned to execute on phase two of the INDIVIOR action agenda accelerate. Looking at our results in more detail, starting with the top line, total net revenue of $358 million for the fourth quarter and approximately $1.24 billion for the full year increased 20% and 4%, respectively.

Speaker #3: Versus the prior year periods. The increase for both periods was driven by strong Sublicate net revenue growth. Total Sublicate net revenue of $252 million for the quarter and $856 million for the year increased 30% and 13%, respectively, versus the prior year periods.

Ryan Preblick: Total SUBLOCADE net revenue of $252 million for the quarter and $856 million for the year, increased 30% and 13%, respectively, versus the prior year periods. For Q4, SUBLOCADE dispense volume grew 12% year-over-year and 6% versus the prior quarter. For the full year, SUBLOCADE dispense volume grew 7%. Gross and net benefits also contributed to the increase in SUBLOCADE net revenue for both periods. Q4 included a gross and net benefit of approximately $19 million and $10 million due to an increase in trade inventory of approximately 2 days. The full year included a gross and net benefit of approximately $49 million. Turning to SUBOXONE Film net revenue, in Q4 and full year, we benefited from continued generic price stability in the US.

Speaker #3: For the fourth quarter, Sublicate dispense volume grew 12% year over year and 6% versus the prior quarter. For the full year, Sublicate dispense volume grew 7%.

Speaker #3: Gross-to-net benefits also contributed to the increase in Sublicate net revenue for both periods. The fourth quarter included a gross-to-net benefit of approximately $19 million, and $10 million due to an increase in trade inventory of approximately two days.

Speaker #3: The full year included a gross-to-net benefit of approximately $49 million. Turning to Suboxone film net revenue, in the fourth quarter and full year, we benefited from continued generic price stability in the US.

Speaker #3: Fourth quarter Suboxone film net revenue included a gross-to-net benefit of $23 million, and the full year included a gross-to-net benefit of $55 million. Total non-GAAP operating expenses were $164 million for the fourth quarter and $622 million for the full year, down 8% and 5%, respectively.

Ryan Preblick: Q4 SUBOXONE Film net revenue included a gross and net benefit of GBP 23 million, and the full year included a gross and net benefit of GBP 55 million. Total non-GAAP operating expenses were GBP 164 million for Q4 and GBP 622 million for the full year, down 8% and 5%, respectively, versus the same year-ago periods. Non-GAAP SG&A expenses were GBP 148 million for Q4, and GBP 545 million for the full year, down 2% and 1%, respectively, versus the prior year periods. The decreases in both periods were driven by reductions in headcount and footprint consolidations across the organization, partially offset by an increased selling and marketing investments behind US SUBLOCADE.

Speaker #3: Versus the same year-ago periods. Non-GAAP SG&A expenses were $148 million for the fourth quarter and $545 million for the full year, down 2% and 1%, respectively, versus the prior year periods.

Speaker #3: The decreases in both periods were driven by reductions in headcount and footprint consolidations across the organization, partially offset by increased selling and marketing investments behind US Sublocade.

Ryan Preblick: Non-GAAP R&D expenses were GBP 17 million for Q4 and GBP 80 million for the full year, down 36% and 22% year-over-year, respectively. The decreases in both periods were driven by the reprioritization of pipeline activities and the restructuring of the R&D and medical affairs organizations. Charges related to the simplification actions we took as part of Phase I of the Indivior Action Agenda were GBP 55 million in Q4 and GBP 120 million in 2025. These charges include severance costs, write-offs for leases, inventory, equipment, and intangibles, as well as other termination payments and consulting costs. The related cash costs were approximately GBP 28 million in 2025. Looking at the bottom line, we generated record adjusted EBITDA for Q4 and full year.

Speaker #3: Non-GAAP R&D expenses were $17 million for the fourth quarter and $80 million for the full year. Down 36% and 22% year over year, respectively.

Speaker #3: The decreases in both periods were driven by the reprioritization of pipeline activities and the restructuring of the R&D and medical affairs organizations. Charges related to the simplification actions we took, as part of phase one of the INDIVIOR action agenda, were $55 million in the fourth quarter and $120 million in 2025.

Speaker #3: These charges include severance costs, write-offs for leases, inventory, equipment, and intangibles, as well as other termination payments and consulting costs. The related cash costs were approximately $28 million in 2025.

Speaker #3: Looking at the bottom line, we generated record-adjusted EBITDA for the fourth quarter and full year. Adjusted EBITDA for the fourth quarter increased 91% year over year to $142 million.

Ryan Preblick: Adjusted EBITDA for Q4 increased 91% year-over-year to GBP 142 million. For the full year, Adjusted EBITDA grew 20% to GBP 428 million, with margin improvement of 500 basis points. We are reaffirming our 2026 financial guidance, which reflects the go-forward operating model we established by completing Phase I of the Indivior Action Agenda. We expect total net revenue in the range of GBP 1.125 billion to 1.195 billion. The modest decline in net revenue at the midpoint versus 2025 is mainly due to the expected US SUBOXONE Film pressure, lower net revenue from the rest of the world due to the optimization we conducted last year, and the continued runoff of PERSERIS.

Speaker #3: For the full year, adjusted EBITDA grew 20% to $428 million, with margin improvement of 500 basis points. We are reaffirming our 2026 financial guidance, which reflects the go-forward operating model we established by completing phase one of the INDIVIOR action agenda.

Speaker #3: We expect total net revenue in the range of $1.125 billion to $1.195 billion. The modest decline in net revenue at the midpoint versus 2025 is mainly due to the expected US Suboxone film pressure, lower net revenue from the rest of the world due to the optimization we conducted last year, and the continued runoff of PCERUS.

Speaker #3: We expect total Sublicate net revenue in the range of $905 to $945 million, representing growth of 8% at the midpoint versus 2025. We expect to accelerate US Sublicate dispense unit growth to the mid-teens in 2026, from from 7% in 2025.

Ryan Preblick: We expect total SUBLOCADE net revenue in the range of GBP 905 to 945 million, representing growth of 8% at the midpoint versus 2025. We expect to accelerate US SUBLOCADE dispensed unit growth to the mid-teens in 2026 from 7% in 2025. By leveraging our new operating model that we've established as part of phase one of the Indivior Action Agenda, Generate Momentum, we expect non-GAAP operating expenses in the range of GBP 430 to 450 million. We expect adjusted EBITDA in the range of GBP 535 to 575 million, which at the midpoint, is an increase of 30% versus 2025 and would represent 13 percentage points of margin expansion to 48%.

Speaker #3: By leveraging our new operating model that we've established as part of phase one of the INDIVIOR action agenda generate momentum, expenses in the range of $430 to $450 million.

Speaker #3: We expect adjusted EBITDA in the range of $535 to $575 million, which at the midpoint is an increase of 30% versus 2025, and would represent 13 percentage points of margin expansion to 48%.

Speaker #3: With the successful completion of phase one of the INDIVIOR Action Agenda, Generate Momentum, we have strengthened our financial profile and will continue to improve upon this foundation as we execute on phase two, Accelerate.

Ryan Preblick: With the successful completion of phase one of the Indivior Action Agenda, Generate Momentum, we have strengthened our financial profile and will continue to improve upon this foundation as we execute on phase two, Accelerate. We ended the year with gross cash and investments of GBP 222 million, even after concluding the legacy DOJ matter by paying the outstanding obligation of GBP 295 million. Excluding the impacts from settlement and restructuring payments, underlying cash flow from operations was over GBP 200 million in 2025. We ended the year with net leverage below 1 time. In 2026, we expect to generate over GBP 300 million in cash flow from operations, enabling us to strategically deploy capital to create long-term value for our shareholders.

Speaker #3: We ended the year with gross cash and investments of $222 million even after concluding the legacy DOJ matter by paying the outstanding obligation of $295 million.

Speaker #3: Excluding the impacts from settlement and restructuring payments, underlying cash flow from operations was over $200 million in 2025. We ended the year with net leverage below one time.

Speaker #3: In 2026, we expect to generate over $300 million in cash flow from operations, enabling us to strategically deploy capital to create long-term value for our shareholders.

Speaker #3: Our capital deployment priorities include managing our debt, returning value to shareholders through opportunistic share repurchases, and evaluating business development opportunities as we earn our way to phase three of the INDIVIOR Action Agenda breakout.

Ryan Preblick: Our capital deployment priorities include managing our debt, returning value to shareholders through opportunistic share repurchases, and evaluating business development opportunities as we earn our way to Phase III of the Indivior Action Agenda, Breakout. Today, we announced that our board authorized a new share repurchase program of up to GBP 400 million, with a term up to 18 months. We plan to utilize this program opportunistically to return value to our shareholders. As we earn our way to Phase III, Breakout, we will evaluate business development opportunities specifically focused on commercial stage assets that have the potential to enhance and diversify our growth profile. Our financial strength provides us with capital deployment optionality. We are committed to taking a disciplined approach. I'll now turn the call back over to Joe for concluding remarks.

Speaker #3: Today, we announce that our board authorized a new share repurchase program of up to $400 million, with a term of up to 18 months. We plan to utilize this program opportunistically to return value to our shareholders.

Speaker #3: And as we earn our way to phase three breakout, we will evaluate business development opportunities, specifically focused on commercial stage assets that have the potential to enhance and diversify our growth profile.

Speaker #3: Our financial strength provides us with capital deployment optionality. We are committed to taking a disciplined approach. I'll now turn the call back over to Joe for concluding remarks.

Speaker #2: Thanks, Ryan. 2025 was a year of significant progress against the INDIVIOR action agenda. We sharpened our focus on our highest growth opportunity: US Sublicate.

Joe Ciaffoni: Thanks, Ryan. 2025 was a year of significant progress against the Indivior Action Agenda. We sharpened our focus on our highest growth opportunity, US SUBLOCADE, established our go-forward operating model, and strengthened our financial profile. We are now executing Phase II of the Indivior Action Agenda, Accelerate, in which we expect to accelerate SUBLOCADE throughout 2026 and immediately accelerate adjusted EBITDA and cash flow at a faster rate. With the establishment of our capital deployment strategy, we are focused on creating long-term value for our shareholders as we work towards becoming a leading, diversified specialty pharmaceutical company, committed to making a positive difference in the lives of people through the commercialization of differentiated medicines. We will now open the call for questions. Operator?

Speaker #2: Established our go-forward operating model, and strengthened our financial profile. We are now executing phase two of the INDIVIOR action agenda accelerate in which we expect to accelerate Sublicate throughout 2026 and immediately accelerate adjusted EBITDA and cash flow at a faster rate.

Speaker #2: With the establishment of our capital deployment strategy, we are focused on creating long-term value for our shareholders as we work towards becoming a leading, diversified specialty pharmaceutical company committed to making a positive difference in the lives of people through the commercialization of differentiated medicines.

Speaker #2: We will now open the call for questions. Operator?

Speaker #3: Thank you. As a reminder, to ask a question, please press *11 on your telephone and wait for your name to be announced. To withdraw your question, please press *11 again.

Ryan Preblick: Thank you. As a reminder to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Once again, please press star one one and wait for your name to be announced. To withdraw your question, please press star one one again. We are now going to proceed with our first question.

Speaker #3: Once again, please press star 11 and wait for your name to be announced. To withdraw your question, please press star 11 again. We are now going to proceed with our first question.

Operator: The questions come from the line of David Amsellem from Piper Sandler. Please ask your question.

Speaker #3: And the questions come from the line of David Amselem from Piper Sandler. Please ask your question.

Operator: The questions come from the line of David Amsellem from Piper Sandler. Please ask your question.

David Amsellem: Hey, thanks. Just a couple here. Joe, I wanted to get your thoughts, just taking a step back, on where you think penetration of LAI buprenorphine modalities ultimately could go to, or what you think would be a reasonable way to think about peak penetration of the category in the OUD space. Secondly, how should we think about share versus your competitor? Obviously, the goal is growing volumes here, and that's been the focus. There's a lot of, I think, investor focus on your share, even though the pie, so to speak, continues to grow. I'm wondering if you can give us some thoughts on share. That would be helpful. Lastly, you mentioned capital deployment in your prepared remarks.

Speaker #4: Hey, thanks. So just a couple here. Joe, I wanted to get your thoughts just taking a step back on where you think penetration of LAI, buprenorphine, modalities ultimately could go to, or what you think would be a reasonable way to think about peak penetration of the category in the OUD space.

Speaker #4: And then secondly, how should we think about share versus your competitor? Obviously, the goal is growing volumes here, and that's been the focus. But there's a lot of, I think, investor focus on your share, even though the pie - so to speak - continues to grow.

Speaker #4: So I'm wondering if you can give us some thoughts on share. That would be helpful. And then lastly, you mentioned capital deployment and you're prepared remarks.

David Amsellem: Wanted to get some more detailed thoughts on business development. What kind of therapeutic adjacencies or other therapeutic areas are you looking at? My assumption is that you're looking at commercial stage assets, but wanted to get more details on your thought process regarding biz devs. Thank you.

Speaker #4: I wanted to get some more detailed thoughts on business development. What kind of therapeutic adjacencies or other therapeutic areas are you looking at? My assumption is that you're looking at commercial stage assets, but wanted to get more details on your thought process regarding this depth.

Speaker #4: Thank you.

Speaker #2: Great, thanks, David. So look, I appreciate your questions. First off, with regard to LAI penetration, we're now embarking upon 9%. So we have to confront the reality of where we are, and we believe there is significant opportunity to continue to grow LAI penetration.

Joe Ciaffoni: Great. Thanks, David. Look, I appreciate your questions. First off, with regards to LAI penetration, we're now embarking upon 9%, so we have to confront the reality of where we are, and we believe there is significant opportunity to continue to grow LAI penetration. We believe that long-acting injectables are underutilized. I'm not gonna get into peak penetration projections. However, I will share with you some analogs and data we look at that will give a sense of what is possible. If you look at categories, like schizophrenia, as an example, from a long-acting injectable perspective, you would see penetration at 30%. I can assure you, we have a lot of market research here at Indivior that would support LAI penetration in the range of 20% to 30%.

Speaker #2: We believe that long-acting injectables are underutilized. I'm not going to get into peak penetration projections. However, I will share with you some analogs and data we look at that will give a sense of what is possible.

Speaker #2: So if you look at categories like schizophrenia as an example from a long-acting injectable perspective, you would see penetration at 30%. I can assure you we have a lot of market research here at INDIVIOR that would support LAI penetration in the range of 20 to 30 percent.

Joe Ciaffoni: My final comment on LAI penetration is we are committed, as the long-standing leader in the space, to doing everything that we can to educate and activate consumers with regards to the important role that long-acting injectables can play. As it pertains to your question on share, what I would emphasize on share, and you're correct, our focus is really first and foremost about driving the market. From a share perspective, we have seen over many quarters our market share stabilizing in the mid 70%. I would emphasize that we're the only entity in the world that has perfect data on the vast majority of the market, and we've been applying a consistent methodology. Importantly, what we are most focused on is new patient share, which has been very strong, as has the absolute number of new patients.

Speaker #2: My final comment on LAI penetration is we are committed as the long-standing leader in the space to doing everything that we can to educate and activate consumers with regards to the important role that long-acting injectables can play.

Speaker #2: As it pertains to your question on share, what I would emphasize on share, and you're correct, our focus is really first and foremost about driving the market.

Speaker #2: From a share perspective, we have seen over many quarters our market share stabilizing in the mid-70%. I would emphasize that we're the only entity in the world that has perfect data on the vast majority of the market, and we've been applying a consistent methodology importantly.

Speaker #2: What we are most focused on is new patient share, which has been very strong as has the absolute number of new patients. We're pretty routinely now achieving all-time highs in new patient starts.

Joe Ciaffoni: We're pretty routinely now achieving all-time highs in new patient starts. To your final question on capital deployment. Look, our start point is there are no commercial assets in the space of opioid use disorder that we believe are there that would enhance our portfolio. Once we made that determination, we'll be establishing a new strategic beachhead in a new therapeutic area. I won't say we're agnostic. There are certainly some areas we wouldn't go into, like cancer gene therapy, but what we're focused on are business fundamentals. We're looking at commercial stage only. We're looking for assets that have peak sales potential of greater than $200 million. It's important to us that the products have a long runway.

Speaker #2: And then to your final question on capital deployment, look, there's nothing our start point is there are no commercial assets in the space of opioid use disorder that we believe are there that would enhance our portfolio.

Speaker #2: Once we made that determination, we'll be establishing a new strategic beachhead and a new therapeutic area. I won't say we're agnostic. There are certainly some areas we wouldn't go into like cancer, gene therapy, but what we're focused on are business fundamentals.

Speaker #2: So we're looking at commercial stage only. We're looking for assets that have peak sales potential of greater than 200 million dollars. It's important to us that the products have a long runway.

Speaker #2: One of the strengths of the INDIVIOR story is we have a great growth driver with adorable runway and Sublicate. So we want to acquire assets that have runway that goes towards the mid to end of 2030 at a minimum.

Joe Ciaffoni: One of the strengths of the Indivior story is we have a great growth driver with a durable runway and SUBLOCADE. We want to acquire assets that have runway that goes towards the mid to end of 2030 at a minimum. Then, of course, we want differentiated assets. We feel that's important from a patient value perspective, but also, when you look at it from a reimbursement perspective, we believe to get the coverage necessary to be successful commercially, that you have to have meaningfully differentiated products.

Speaker #2: And then, of course, we want differentiated assets. We're not interested in being an aggregator of commoditized brands. We feel that's important from a patient value perspective, but also when you look at it from a reimbursement perspective, we believe to get the coverage necessary to be successful commercially, you have to have meaningfully differentiated products.

David Amsellem: Okay, helpful. Thanks.

Speaker #4: Helpful. Thanks.

Speaker #2: Thanks, David.

Joe Ciaffoni: Thanks, David.

Speaker #3: We are now going to proceed with our next question. And the questions come from the line of Chase Nicobelka from Craig Hallum. Please ask your question.

Operator: We are now going to proceed with our next question. The questions come from the line of Chase Knickerbocker from Craig-Hallum. Please ask your question.

Chase Knickerbocker: Good morning, guys. Congrats on the results here, and thanks for taking the questions. Maybe just first digging in a little bit more to guide. Can you just kind of delineate what your guidance assumes from an LAI market growth perspective in 26? You know, to ask, I think, this question just a little bit differently on the, on the share, what does it assume for share in 2026? Just kind of zooming in on the guide specifically, Joe. Thanks.

Speaker #5: Good morning, guys. Congrats on the results here, and thanks for taking the questions. Maybe just first digging in a little bit more to guide.

Speaker #5: Can you just kind of delineate what your guidance assumes from an LAI market growth perspective in '26? And then, to ask Dave's question just a little bit differently on the share, what does it assume for share in 2026?

Speaker #5: Just kind of zooming in on the guide specifically, Joe. Thanks.

Speaker #2: Yeah. Chase, thanks for the question. On the Sublicate guide, I'm not going to get into an LAI penetration assumption. We're assuming mid-teens Sublicate growth, which is a significant step up from where it is that Sublicate was in 2025.

Joe Ciaffoni: Yeah. Chase, thanks for the question. On the SUBLOCADE guide, I'm not gonna get into an LAI penetration assumption. We're assuming mid-teen SUBLOCADE growth, which is a significant step up from where it is that SUBLOCADE was in 2025. I will comment on a market share perspective. We do expect to see continued stabilization of SUBLOCADE market share.

Speaker #2: And I will comment on a market share perspective. We do expect to see continued stabilization of Sublicate market share.

Speaker #5: And just as we wrap up 2025, like you had mentioned, you guys kind of have perfect data. Can you just kind of update us on what LAI market growth was in 2025?

Chase Knickerbocker: Just as we wrap up 2025, you know, like you had mentioned, you guys kind of have perfect data. Can you just kind of update us on what LAI market growth was in 2025? Then my last question, Joe Ciaffoni, is just a little bit more, you know, I'd appreciate some more thoughts on kind of buyback versus M&A, is just kind of where they are on the priority list. Is this something where you'll kind of be opportunistic on M&A, and then in the meantime, you know, you guys will be, you know, fairly aggressive on the buyback as far as that being kind of the primary capital allocation, after you service your debt, of course?

Speaker #5: And then my last question, Joe, is just a little bit more—I'd appreciate some more thoughts on kind of buyback versus M&A, as just kind of where they are on the priority list.

Speaker #5: Is this something where you'll kind of be opportunistic on M&A and in the meantime you guys will be fairly aggressive on the buyback as far as that being kind of the primary capital allocation after you service your debt, of course.

Joe Ciaffoni: Okay, thanks, Chase. I'll let Pat take the first question and let Ryan comment on the second.

Speaker #2: Okay. Thanks, Chase. I'll let Pat take the first question and let Ryan comment on the second.

Speaker #6: Yeah. And LAI category growth for Q4, we were approaching 18%. And so again, really strong category growth.

Patrick Barry: Yeah, in LAI category growth, for Q4, we were approaching 18%. Again, really strong category growth.

Speaker #4: Hey, Chase. Good morning. So when it comes to capital allocation, due to our financial strengths and the strong cash flow, from the business, we have options here.

Ryan Preblick: Hey, Chase, good morning. When it comes to capital allocation, you know, due to our financial strengths and the strong cash flow from the business, we have options here. It's not about or, it's about and. If you start with the debt, we know right now we do have expensive debt, but as part of our normal cadence, it is something that we are looking at, and it is something that, you know, we will take care of in the near future. If you look at the share repurchase, this is another option we have to deliver value to our shareholders. We authorized the $400 million program to be ready, to be prepared to buy back shares and be opportunistic.

Speaker #4: And it's not about or it's about and. And if you start with the debt, right now, we do have expensive debt. But as part of our normal cadence, it is something that we are looking at, and it is something that we will take care of in the near future.

Speaker #4: If you look at the share repurchase, this is another option we have. To deliver value to our shareholders. We authorized the $400 million program to be ready, to be prepared to buy back shares and be opportunistic.

Ryan Preblick: That decision will be made in the context of what else is going on in the business at that point, in regards to the debt conversation, BD, making sure we have the right capacity for investments behind SUBLOCADE. Also, you know, we need to evaluate if there's still a gap between the share price and what we believe the value of the company is. Finally, when it gets to the business development, you know, we're still earning our way to phase three, the Breakout, where, as Joe just said, you know, we're gonna look at BD, including buying commercial assets. Overall, we are definitely focused on driving shareholder value.

Speaker #4: That decision will be made in the context of what else is going on in the business at that point in regards to the debt conversation, BD, making sure we have the right capacity for investments behind Sublicate.

Speaker #4: So, and then also, we need to evaluate if there's still a gap between the share price and what we believe the value of the company is.

Speaker #4: And then finally, when it gets to the business development, we're still earning our way through phase three to breakout where, as Joe just said, we're going to look at BD including buying commercial assets.

Speaker #4: So overall, we are definitely focused on driving shareholder value.

Speaker #5: Great. Thank you.

Chase Knickerbocker: Great. Thank you.

Speaker #2: Thanks, Chase.

Joe Ciaffoni: Thanks, Chase.

Speaker #3: We are now going to move to our next question, and the question comes from the line of Dennis Sting from Jefferies. Please ask your question.

Operator: We are now going to proceed with our next question. The question come from the line of Dennis Ding from Jefferies. Please ask the question.

Speaker #7: Hi. Good morning. Thanks for taking our questions. I have two. So, number one, what are your thoughts on the overall Medicaid funding landscape and the potential impact on Sublocade from less funding in 2027?

Dennis Ding: Hi, good morning. Thanks for taking our questions. I have two. Number one, what are your thoughts on the overall Medicaid funding landscape and the potential impact on SUBLOCADE from less funding in 2027? How confident are you around maintaining that mid-teens unit growth in the US in 2027 and after? Number two, on SG&A, I'm just curious about the shape of SG&A in 2026, given it was GBP 148 in Q4. If you can comment on how much you are spending on DTC in 2026, and, you know, at what point would you reevaluate that DTC spend in terms of growing or shrinking that? Thank you.

Speaker #7: And how confident are you around maintaining that mid-teens unit growth in the US in 2027? And after? And then number two, on SG&A, I'm just curious about the shape of SG&A in 2026 given it was 148 in Q4.

Speaker #7: And if you can comment on how much you are spending on DTC in '26. And at what point would you reevaluate that DTC spend in terms of growing or shrinking that?

Speaker #7: Thank you.

Joe Ciaffoni: Yeah. Dennis, thanks for the question. First off, with regards to DTC, we're not gonna get into how much we're spending for competitive reasons. What I will assure you is we're making every investment in support of it, and we're actually over-investing beyond what our models would suggest that we should. We're also committed to investing behind DC at those levels for a multiyear period, because at the end of the day, the most important thing that we can do is educate and drive long-acting injectable penetration. As it pertains to Medicaid, I'm not gonna get into, we're just starting 2026, what we think growth would look like in 2027. What I can tell you is, one, we advocate for and are hopeful from a humanistic perspective, that everybody who should be supported by Medicaid is supported.

Speaker #2: Yeah. Dennis, thanks for the question. First off, with regards to DTC, we're not going to get into how much we're spending for competitive reasons.

Speaker #2: What I will assure you is we're making every investment in support of it, and we're actually overinvesting beyond what our models would suggest that we should.

Speaker #2: We're also committed to investing behind DC at those levels. For a multi-year period, because at the end of the day, the most important thing that we can do is educate and drive long-acting injectable penetration.

Speaker #2: As it pertains to Medicaid, I'm not going to get into. We're just starting 2026. What we think growth would look like in 2027. What I can tell you is, one, we advocate for and are hopeful from a humanistic perspective that everybody who should be supported by Medicaid is supported.

Joe Ciaffoni: We believe that overall, if you look at the various legislation, it's generally supportive, and we view that as a bipartisan support to helping people with substance use and opioid use disorder. The final point I would make, at 8, 9% long-acting injectable penetration, there is so much opportunity for growth with SUBLOCADE across the board, inclusive of Medicaid. It will not be impacted whether Medicaid population is plus or minus a certain percentage. I'll give Ryan the opportunity to comment on SG&A.

Speaker #2: We believe that overall, if you look at the various legislation, it's generally supportive and we view that as a bipartisan support to helping people with substance use and opioid use disorder.

Speaker #2: And then the final point I would make at eight, nine percent long-acting injectable penetration—there's so much opportunity for growth with Sublicate across the board, inclusive of Medicaid—it will not be impacted whether Medicaid population is plus or minus a certain percentage.

Speaker #2: And then I'll give Ryan the opportunity to comment on SG&A.

Speaker #6: Yeah. Good morning. In regards to the step up in Q4, that was simply us taking advantage of our DTC campaign tested really well. And we had the opportunity to start it early.

Ryan Preblick: Yeah, good morning. In regards to the step-up in Q4, that was simply us taking advantage of our DTC campaign, tested really well, and we had the opportunity to start it early. That's the expense you're seeing in Q4. Around phasing for 2026, our quarters are relatively flat. You may see some skew to the first three quarters just due to the campaign we have in place.

Speaker #6: So that's the expense you're seeing in Q4. And around phasing for 2026, our quarters are relatively flat. You may see some skew to the first three quarters just due to the campaign we have in place.

Dennis Ding: Helpful. Thank you.

Speaker #5: Helpful. Thank you.

Joe Ciaffoni: Thanks, Dennis.

Speaker #2: Thanks, Dennis.

Operator: We are now going to proceed with our next question. The question come from the line of Christian Glennie from Stifel. Please ask your question.

Speaker #3: We are now going to proceed with our next question. And the questions come from the line of Christian Glennie from Stifel. Please ask your question.

Christian Glennie: Hi. Thanks, guys. Thanks for taking the questions. First one would be on the SUBLOCADE and the guide. Just so I guess, to understand it properly, obviously, you had meaningful gross to net benefits. Is the idea that we, you know, adjust for that, take that off in terms of the base, the underlying, I guess, base for SUBLOCADE, that gets you, if you're doing mid-teens, that gets you to the sort of the range that you've guided to? As in, I'm trying to, you know, compare the 8% net revenue guide versus your mid-teens guidance in dispense growth.

Speaker #5: Hi. Thanks, guys. Thanks for taking the questions. First one would be on the Sublicate and the guide. Just so I guess to understand it properly, obviously, you had meaningful growth-to-net benefits.

Speaker #5: So is the idea that we adjust for that, take that underlying, I guess, base for Sublicate that gets you, if you're doing mid-teens, that gets you to sort of the range that you're guided to as in I'm trying to compare the 8% net revenue guide versus your mid-teens guidance in dispense growth.

Joe Ciaffoni: Sure. Thanks for the correct, the question, Christian. Look, in 2025, gross to net served as a tailwind. In 2026, gross to net will serve as a headwind to the business. The key component of the guide is the following: We're gonna grow and accelerate dispense unit growth to the mid-teens, and we're assuming that we're gonna continue to see a stabilization of market share.

Speaker #2: Sure. Thanks for the question, Christian. So, look, in 2025, growth-to-net served as a tailwind. In 2026, growth-to-net will serve as a headwind to the business.

Speaker #2: So the key component of the guide is the following: we're going to grow and accelerate dispense unit growth to the mid-teens. And we're assuming that we're going to continue to see a stabilization of market share.

Speaker #5: Okay. Thank you. And then on the, I guess, just obviously, funny enough, if we're going back to the capital markets day 2022, the you talked about an exit rate to billion-dollar exit rate by the end of '25.

Christian Glennie: Okay, thank you. On the, I guess, just obviously, you know, funny enough, if we're going back to the capital markets day 2022, you talked about an exit rate to, you know, billion-dollar exit rate by the end of 25. You've actually gone and actually done that. I guess, any observations about, you know, the potential to breach that billion-dollar number?

Speaker #5: You've actually gone and actually done that. So I guess any observations about the potential to breach that billion-dollar number?

Speaker #2: Yeah. So look, I appreciate the question. We're not going to get into any peak sales projections forward-looking when we're going to hit certain thresholds.

Joe Ciaffoni: Yeah. look, I appreciate the question. We're not gonna get into any peak sales projections, any forward-looking, when we're gonna hit certain thresholds. What we're focused on is delivering on the financial commitments that we made to everyone for 2026. The final comment I would make there is, we are very confident with SUBLOCADE that we have a durable growth driver, and I think we're just scratching the surface on the potential of this asset, both from a business perspective, but candidly, more importantly, in the potential it has to make a difference in a positive way in the lives of people living with opioid use disorder and the communities that we serve.

Speaker #2: What we're focused on is delivering on the financial commitments. That we made to everyone for 2026 or for 2026. And the final comment I would make there is we are very confident with Sublicate that we have a durable growth driver.

Speaker #2: And I think we're just scratching the surface on the potential of this asset, both from a business perspective, but candidly, more importantly, in the potential it has to make a difference in a positive way in the lives of people living with opioid use disorder in the communities that we serve.

Speaker #5: Thanks. And my final one, if I can, maybe just to clarify a previous comment around new assets. And he talks about being well-served obviously in OUD.

Christian Glennie: Thanks. My final one, if I can, maybe just to clarify a previous comment around new assets. You talked about being well-served, obviously, in OUD, but in terms of, it seemed to apply other therapeutic areas, but would that include other addiction areas, or is it outside addiction?

Speaker #5: But in terms of and it seems to apply other therapeutic areas, but would that include other addiction areas or is it outside addiction?

Speaker #2: Yeah. So look, I appreciate the question. First thing I want to emphasize—we're head down in Phase Two Accelerate, and we've been clear we need to earn our way to Phase Three Breakout.

Joe Ciaffoni: Yeah. Look, I appreciate the question. First thing I wanna emphasize, we're head down in Phase II Accelerate, and we've been clear we need to earn our way to Phase III Breakout. I would not have an expectation that anything we do from an acquisition perspective would be focused on opioid use disorder or substance use disorder. I would think of different therapeutic areas than that, but I would bring you back to the business fundamentals that will really drive what it is that we're looking to achieve. Commercial stage, peak sales potential greater than $200 million, a long and durable runway in front of it, and a differentiated asset that would deliver both patient value and enable us to get the reimbursement we feel is necessary to be successful commercially.

Speaker #2: I would not have an expectation that anything we do from an acquisition perspective would be focused on opioid use disorder or substance use disorder.

Speaker #2: So I would think of different therapeutic areas than that. But I would bring you back to the business fundamentals that will really drive what it is that we're looking to achieve.

Speaker #2: Commercial stage, peak sales potential greater than 200 million dollars, a long and durable runway in front of it, and a differentiated asset that would deliver both patient value and enable us to get the reimbursement we feel is necessary to be successful commercially.

Speaker #5: Great. Thank you.

Christian Glennie: Great. Thank you.

Speaker #2: Welcome. Thank you.

Joe Ciaffoni: Welcome. Thank you.

Operator: We are now going to proceed with our next question. The question comes from the line of Brandon Folkes from H.C. Wainwright. Please ask your question.

Speaker #3: We are now going to proceed with our next question. And the questions come from the line of Brandon Forks from HC Wainwright. Please ask your question.

Brandon Folkes: Hi, thanks so much for taking my call, and congrats. Maybe just a quick one for me. Can you just talk about how you think contribution from the Criminal Justice System opportunity in your 2026 SUBLOCADE guidance? Thank you.

Speaker #7: Hi. Thanks so much for taking my time. Congrats. Maybe just a quick one for me. Can you just talk about a hypothetical contribution from the criminal justice system opportunity in your 2026 Sublicate guidance?

Speaker #7: Thank you.

Joe Ciaffoni: Yeah. Thanks, Brandon. I'm gonna give that one to Pat.

Speaker #2: Yeah. Thanks, Brandon. I'm going to give that one to Pat.

Speaker #6: Yeah. No, I appreciate the question, Brandon. We see the criminal justice segment as a strong opportunity for us. We see it as a rebase business.

Patrick Barry: Yeah, no, I appreciate the question, Brandon. We see the criminal justice segment as a strong opportunity for us. We see it as a rebase business, and from there, we believe we can grow. Also, SUBLOCADE is a differentiated asset. It's the only monthly with a long-acting injectable monthly with the rapid induction, and you have prescribers that are familiar and comfortable with it. In that context, we do believe it can contribute to the growth that we're guiding to on mid-teens. Obviously, we're looking at the broader opportunity. While CJS is a part of it, we're looking at the opportunity as the category leader to continue to fuel and grow the overall LAI category.

Speaker #6: And from there, we believe we can grow. Also, Sublicate is a differentiated asset. It's the only monthly with a long-acting injectable monthly with the rapid induction and you have prescribers that are familiar and comfortable with it.

Speaker #6: So in that context, we do believe it can contribute to the growth that we're guiding to on mid-teens. But obviously, we're looking at the broader opportunity while CJS is a part of it.

Speaker #6: We're looking at the opportunity as the category leader to continue to fuel and grow the overall LAI category.

Operator: We are now going to proceed with our next question. The question comes from the line of Thibault Boutherin from Morgan Stanley. Please ask your question.

Speaker #3: We are now going to proceed with our next question. And the questions come from the line of Thibaut Boutterin from Morgan Stanley. Please ask your question.

Thibault Boutherin: Yes, thank you. Thank you for the clarification on SUBLOCADE guidance between the 60 and 8%. There's also another element, it's small, but SUBLOCADE ex US. How should we think about that line of revenues given the organization changes you've made, sorry. Should we expect this to stabilize? Could it decline next year? Just if you could help us on that. Then just on R&D, obviously, you're going to have two phase III go, no-go decision in the next few weeks. How should we think about the impact of the different scenarios on your OpEx guidance if you take zero, one, or two asset to phase III? Thank you.

Speaker #8: Yes. Thank you. And thank you for the clarification on Sublicate guidance between the '16 and the 8%. There is also another element. It's small, but Sublicate XUS, how should we think about that line of revenues given the organization changes they've made?

Speaker #8: You've made—sorry. So, should we expect this to stabilize? Could it decline next year, just if you could help us on that? And then just on R&D, obviously, you're going to have two Phase 3 go/no-go decisions in the next few weeks.

Speaker #8: And how should we think about the impact of the different scenarios on your OPEX guidance if you take 0, 1, or 2 asset to phase three?

Speaker #8: Thank you.

Speaker #2: Sure. I'll let Ryan take the first question, and then Christian and I will split the second.

Joe Ciaffoni: Sure. I'll let Ryan take the first question, and then Christian and I will split the second.

Speaker #6: Certainly. Good morning. So on Sublicate and the rest of the world, it's going to be relatively flat year over year. We will see growth in Australia and Canada.

Ryan Preblick: Certainly. Good morning. On SUBLOCADE and the rest of the world, it's gonna be relatively flat year-over-year. We will see growth in Australia and Canada, but we will lose some of the volume coming out of the Nordics.

Speaker #6: But we will lose some of the volume coming out of the Nordics.

Speaker #2: Okay. And then with regards to R&D, I'll let Christian comment on the programs and timing of the phase two readouts. What I would tell you is our budget for 2026 contemplates if we have the opportunity to advance those programs that is built into the operating budget that we're working towards.

Joe Ciaffoni: Okay. With regards to R&D, I'll let Christian comment on the programs and timing of the phase 2 readouts. What I would tell you is our budget for 2026 contemplates if we have the opportunity to advance those programs, that is built into the operating budget that we're working towards. Christian?

Speaker #2: Christian?

Christian Heidbreder: Yes, based on what Joe just said, the 2 phase II trials were completed at the end of Q4 last year. We are now going through the traditional process of data cleaning, data closeout, and statistical programming. This will be followed by database log by the end of Q1 this year, with the final tables, figures, and listings available in Q2 this year for preparation of top line results on both assets. I must add that in addition of INDV-6001, in addition to the phase II data, the decision to proceed to late stage clinical development, that is the phase III, hinges on 3 additional factors. First, the manufacturing feasibility and the availability of the drug product for the actual phase III.

Speaker #8: Yeah. So based on what Georgia said, the two phase two trials were completed at the end of the fourth quarter last year. We are now going through the traditional process of data cleaning, data closeout, and statistical programming.

Speaker #8: This will be followed by database logged by the end of the first quarter. This year, with the final tables figures and listings available in the second quarter of this year, for preparation of top-line results on both assets.

Speaker #8: Now, I must add that in addition for INDV 6001, in addition to the phase two data, the decision to proceed to late-stage clinical development, that is the phase three, hinges on three additional factors.

Speaker #8: First, the manufacturing feasibility and the availability of the drug product for the actual phase three. Second, we are currently running a payer validated differentiation and evidence that is going to be required for coverage based on the target product profile research.

Christian Heidbreder: Second, we are currently running a payer validated differentiation and evidence that is going to be required for coverage based on the target product profile research. Three, the impact of that research on the clinical phase III trial design, if indeed this is what the business decides to do.

Speaker #8: And then three, the impact of that research on the clinical phase three trial design if indeed this is what the business decides to do.

[Analyst]: Thank you.

Thibault Boutherin: Thank you.

Speaker #5: Thank ank you.

Speaker #2: You're welcome.

Christian Heidbreder: You're welcome.

Operator: Thank you. This concludes the question and answer session and today's conference call. Thank you all for participating. You may now disconnect.

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