Indivior Pharmaceuticals, Inc (INDV) 2025 Q4 法說會逐字稿

Good day and thank you for standing by. Welcome to Indivior Pharmaceuticals, Inc.'s fourth-quarter and full-year 2025 results conference call and webcast. (Operator Instructions) 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 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 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'll now turn the call over to Joe Ciaffoni, our CEO.

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 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'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, 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'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 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 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. 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 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. 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 2, accelerate, in 2026.

I'll now turn the call over to Pat.

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 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. 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 five or more patients.

In the Q4, both total active SUBLOCADE prescribers and prescribers treating five 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 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.

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.

Branded online search volume increased 60% in the 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 the 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 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'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.

We simplified the organization while strengthening our financial profile. We are well-positioned to execute on Phase 2 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 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.

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 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.

The Q4 included a gross and net benefit of approximately $19 million and $10 million due to an increase in trade inventory of approximately two days. The full year included a gross and net benefit of approximately $49 million.

Turning to SUBOXONE Film net revenue, in the Q4 and full year, we benefited from continued generic price stability in the US. Q4 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 Q4 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 Q4 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 an increased selling and marketing investments behind US SUBLOCADE.

Non-GAAP R&D expenses were $17 million for the Q4 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 1 of the Indivior Action Agenda were $55 million in the Q4 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 Q4 and full year. Adjusted EBITDA for the Q4 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 1 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 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.

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 US SUBLOCADE dispense 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 1 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 1 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 2, 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 one 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'll 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, US 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?

(Operator Instructions)

David Amsellem, Piper Sandler.

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 we 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. I'm 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're 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'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%-30%.

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.

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.

One of the strengths of the Indivior story is we have a great growth driver with a durable runway and SUBLOCADE, we wanna acquire assets that have runway that goes towards the mid to end of 2030 at a minimum. 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, that you have to have meaningfully differentiated products.

Okay. Helpful. Thanks.

Thanks, David.

Chase Knickerbocker, Craig-Hallum.

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'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.

Just as we wrap up 2025, you know, like you had mentioned, you guys kinda have perfect data. Can you just kinda update us on what LAI market growth was in 2025? My last question, Joe, is just a little bit more, you know, I'd appreciate some more thoughts on kind of buyback versus M&A. It's 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?

Okay, thanks, Chase. I'll 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's not about or, it's 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's 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're still earning our way to Phase 3, the breakout, where, as Joe Ciaffoni just said, you know, we're gonna look at BD, including buying commercial assets. Overall, we are definitely focused on driving shareholder value.

Great. Thank you.

Thanks, Chase.

Dennis Ding, Jefferies.

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 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 $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.

Yeah. Dennis, thanks for the question. With regards to DTC, we're not going to 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 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'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. We believe that overall, if you look at the various legislation, it's 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'll 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'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.

Helpful. Thank you.

Thanks, Dennis.

Christian Glennie, Stifel.

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're doing mid-teens, that gets you to the sort of the range that you've 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'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.

Okay, thank you. Then 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 2025. You've 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're not going to get into any peak sales projections, any forward-looking, when we're going to hit certain thresholds. What we're 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'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.

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're head down in Phase 2 accelerate, and we've 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'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.

Great. Thank you.

Welcome. Thank you.

Brandon Folkes, H.C. Wainwright.

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'm gonna 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's 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'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.

Thibault Boutherin, Morgan Stanley.

Yes, thank you. Thank you for the clarification on SUBLOCADE guidance between 50% 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 they've made, you've 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're going to have two Phase 3 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 zero, one, or two assets to Phase 3? Thank you.

Sure. I'll 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'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.

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?

Yes. Based on what Joe just said, the two Phase 2 trials were completed at the end of the Q4 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 log by the end of the Q1 this year, with the final tables, figures, and listings available in the Q2 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 2 data, the decision to proceed to late-stage clinical development, that is the Phase 3, hinges on three additional factors. First, the manufacturing feasibility and the availability of the drug product for the actual Phase 3.

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 3 trial design, if indeed, this is what the business decides to do.

Thank you.

You're welcome.

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