INDV - NASDAQ

Thank you for standing by. Welcome to Indivior Pharmaceuticals Inc's fourth quarter 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 11 on your telephone. 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. I would now like to hand the conference over to Jason Thompson, your host for today's call. Please go ahead.

Thank you, and good morning, everyone. I am joined today by Joseph J. Ciaffoni, Chief Executive Officer, Patrick A. Barry, Chief Commercial Officer, and Ryan Preblick, Chief Financial Officer. We are 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 2 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 will now turn the call over to Joseph J. Ciaffoni, our CEO.

Thanks, Jason, 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. Pat will then provide a commercial update and discuss our priorities for SUBLOCADE. Finally, Ryan will review our financial performance, 2026 guidance, and then 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 have 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, 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. We took several actions to simplify our organization and establish Indivior Pharmaceuticals Inc'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 October 1, 2025, to drive awareness of SUBLOCADE among people living with opioid use disorder. 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 Pharmaceuticals Inc 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. With phase one of the Indivior Action Agenda completed and our go-forward operating model firmly established, we are now executing on phase two 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. 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 the first quarter. 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. 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 3 of the Indivior Action Agenda Breakout. 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 two, Accelerate, in 2026. I will now turn the call over to Patrick A. Barry.

Thanks, Joe, and good morning, everyone. As part of phase one 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 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. 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. Total category share of LAIs and new patient share in the U.S. 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 the 4th quarter, 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. Our efforts are centered on driving excellence in 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. 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 first quarter of 2025. 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 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 the fourth quarter, 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 cost, and administrative burden for providers. Expanding coverage under a pharmacy benefit would reduce these barriers, lower financial risk, and improve provider adoption. 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-teens dispense unit growth in 2026. I will now turn the call over to Ryan.

Thanks, Pat. Good morning. First, I will highlight our fourth quarter 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. We simplified the organization while strengthening our financial profile. 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, versus the prior year periods. The increase for both periods was driven by strong SUBLOCADE net revenue growth. 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 the fourth quarter, SUBLOCADE dispense volume grew 12% year-over-year and 6% versus the prior quarter. For the full year, SUBLOCADE dispense volume grew 7%. Gross-to-net benefits also contributed to the increase in SUBLOCADE net revenue for both periods. The fourth quarter 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 the fourth quarter and full year, we benefited from continued generic price stability in the U.S. Fourth quarter SUBOXONE Film net revenue included a gross and net benefit of $23 million, and the full year included a gross and 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, 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. 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 U.S. SUBLOCADE. 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. 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. 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. 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. 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. We expect total net revenue in the range of $1.125 billion-$1.195 billion. The modest decline in net revenue at the midpoint versus 2025 is mainly due to the expected U.S. 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. We expect total SUBLOCADE net revenue in the range of $905 million-$945 million, representing growth of 8% at the midpoint versus 2025. We expect to accelerate U.S. SUBLOCADE dispense unit growth to the mid-teens in 2026 from 7% in 2025. By leveraging our new operating model that we have established as part of phase one of the Indivior Action Agenda, Generate Momentum, we expect non-GAAP operating expenses in the range of $430 million-$450 million. We expect adjusted EBITDA in the range of $535 million-$575 million, which at the midpoint, is an increase of 30% versus 2025 and would represent 13 percentage points of margin expansion to 48%. 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 $222 million, even after concluding the legacy DOJ matter by paying the outstanding obligation of $295 million. 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 1 time. 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. 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 3 of the Indivior Action Agenda Breakout. Today, we announced that our board authorized a new share repurchase program of up to $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 3 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 will now turn the call back over to Joe for concluding remarks.

Thanks, Ryan. 2025 was a year of significant progress against the Indivior Action Agenda. We sharpened our focus on our highest growth opportunity, U.S. SUBLOCADE, established our go-forward operating model, and strengthened our financial profile. We are now executing phase 2 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?

Thank you. As a reminder to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. 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. The questions come from the line of David Amsellem from Piper Sandler. Please ask your question.

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. Then secondly, how should we think about share versus your competitor? Obviously, the goal is growing volumes here, and that has been the focus, but there is a lot of, I think, investor focus on your share, even though the pie, so to speak, continues to grow. I am wondering if you can give us some thoughts on share. That would be helpful. Then lastly, you mentioned capital deployment in your prepared remarks. 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 are looking at commercial stage assets, but wanted to get more details on your thought process regarding biz devs. Thank you.

Great. Thanks, David. Look, I appreciate your questions. First off, with regards to LAI penetration, we are 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 am 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. 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 Pharmaceuticals Inc that would support LAI penetration in the range of 20%-30%. My final comment on LAI penetration is we are committed, as the longstanding 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 are 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 are the only entity in the world that has perfect data on the vast majority of the market, and we have 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. We are 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 will be establishing a new strategic beachhead in a new therapeutic area. I will not say we are agnostic. There are certainly some areas we would not go into, like cancer gene therapy, but what we are focused on are business fundamentals. We are looking at commercial stage only. We are looking for assets that have peak sales potential of greater than $200 million. It is important to us that the products have a long runway. One of the strengths of the Indivior Pharmaceuticals Inc story is we have a great growth driver with a durable runway in SUBLOCADE, we want to acquire assets that have runway that goes towards the mid to end of 2030 at a minimum. Of course, we want differentiated assets. We are not interested in being an aggregator of commoditized brands. We feel that is 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.

Okay. Helpful. Thanks.

Thanks, David.

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

Good morning, guys. Congrats on the results here, 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 2026? Then, you know, to ask, I think, this question just a little bit differently on the share, what does it assume for share in 2026? Just kind of zooming in on the guide specifically, Joe. Thanks.

Yeah. Chase, thanks for the question. On the SUBLOCADE guide, I am not going to get into an LAI penetration assumption. We are 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.

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? My last question, Joe, is just a little bit more, you know, I would appreciate some more thoughts on kind of buyback versus M&A. It is just kind of where they are on the priority list. Is this something where you will 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?

Okay, thanks, Chase. I will let Pat take the first question and let Ryan comment on the second.

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

Hey, Chase, good morning. When it comes to capital allocation, you know, due to our financial strength and the strong cash flow from the business, we have options here. It is not about or, it is about and. If you start with the debt, you 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. 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. And then also, you know, we need to evaluate if there is still a gap between the share price and what we believe the value of the company is. And then finally, when it gets to the business development, you know, we are still earning our way to phase 3, the Breakout, where, as Joseph J. Ciaffoni just said, you know, we are going to look at BD, including buying commercial assets. Overall, we are definitely focused on driving shareholder value.

Great. Thank you.

Thanks, Chase.

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

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-teen unit growth in the U.S. in 2027 and after? Number two, on SG&A, I am just curious about the shape of SG&A in 2026, given it was $148 million 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.

Yeah. Dennis, thanks for the question. With regards to DTC, we are not going to get into how much we are spending for competitive reasons. What I will assure you is we are making every investment in support of it, and we are actually over-investing beyond what our models would suggest that we should. We are also committed to investing behind DTC 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. As it pertains to Medicaid, I am not going to get into, we are 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. We believe that overall, if you look at the various legislation, it is generally supportive, 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 ± a certain %. I will give Ryan the opportunity to comment on SG&A.

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 is the expense you are 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.

Helpful. Thank you.

Thanks, Dennis.

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

Hi, thanks, guys. Thanks for taking the questions. First one would be on 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 are doing mid-teens, that gets you to the sort of the range that you have guided to? As in, trying to, you know, compare the 8% net revenue guide versus your mid-teens guidance in dispense growth.

Thanks for 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 are going to grow and accelerate dispense unit growth to the mid-teens, and we are assuming that we are going to continue to see a stabilization of market share.

Okay, thank you. Then on the, I guess, just obviously, you know, funny enough, if we are 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 2025. You have actually gone and actually done that. I guess, any observations about, you know, the potential to breach that billion-dollar number?

I appreciate the question. We are not going to get into any peak sales projections, any forward-looking, when we are going to hit certain thresholds. What we are focused on is delivering on the financial commitments that we made to everyone for 2026, or 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 are 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.

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, in terms of it seemed to apply other therapeutic areas. Would that include other addiction therapeutic areas, or is it outside addiction?

I appreciate the question. First thing I want to emphasize, we are head down in phase 2 Accelerate, and we have been clear we need to earn our way to phase 3 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 are 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.

Great. Thank you.

Welcome. Thank you.

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

Hi. Thanks so much for taking my call. 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.

Yeah. Thanks, Brandon. I am going to give that one to Pat.

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. From there, we believe we can grow. Also, SUBLOCADE is a differentiated asset. It is the only monthly with a long-acting injectable monthly with the rapid induction. You have prescribers that are familiar and comfortable with it. In that context, we do believe it can contribute to the growth that we are guiding to on mid-teens. Obviously, we are looking at the broader opportunity. While CJS is a part of it, we are looking at the opportunity as the category leader to continue to fuel and grow the overall LAI category.

We are now going to proceed with our next question. The question's come from the line of Thibault Boutherin from Morgan Stanley. Please ask your question.

Yes, thank you. Thank you for the clarification on SUBLOCADE guidance between 15% and 8%. There is also another element, it is small, but SUBLOCADE ex U.S., how should we think about that line of revenues given the organization changes they have made, you have made, sorry. Should we expect this to stabilize? Could it decline next year? Just if you could help us on that. Just on R&D, obviously you are going to have 2 phase III go-no-go decisions in the next few weeks. How should we think about the impact of the different scenarios on your OpEx guidance if you take 0, 1, or 2 assets to phase III? Thank you.

Sure. I will let Ryan take the first question, and then Christian and I will split the second.

Certainly. Good morning. On SUBLOCADE and the rest of the world, it is going to 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.

Okay. With regards to R&D, I will let Christian comment on the programs and timing of the phase II 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 are working towards. Christian?

Yes. Based on what Joe just said, the 2 phase II 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. This will be followed by a database lock 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. 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. 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. Third, the impact of that research on the clinical phase III trial design, if indeed, this is what the business decides to do.

Thank you.

You are welcome.