Thank you, Einar, and hello, everyone. Welcome to our fourth quarter earnings call and full year.

As customary, please note our forward-looking statements, which I will assume that you have read. Moving over to the agenda, we will begin today's call with an introduction and business highlights, followed by financial, commercial, and R&D pipeline reviews before finishing off with key takeaways and Q&A.

With me in the call today is Anders Vadsholt, Chief Financial Officer, and Richard Jameson, Chief Commercial Officer. A quick overview of Camurus.

We are a rapidly growing, commercial-stage biopharmaceutical company focused on developing and delivering innovative, long-acting treatments for people living with serious and chronic illnesses. We have become a global leader in opioid dependence therapy with our products Buvidal and Brixadi.

Our commercial reach covers Europe and Australia, and we are now expanding into the US as we gear up for upcoming product launches. At the core of our offerings is the FluidCrystal technology, which supports advanced long-acting injectable treatments and has proven successful through both our commercial and clinical results and collaborations.

Alongside our meaningful investments in the R&D pipeline, we have maintained sustainable profitability since 2022, placing us in a good position for ongoing growth. Now turning to full-year highlights.

In 2025, we achieved several significant milestones that further strengthened our leadership in opioid dependence treatment and our ongoing expansion. We continued to build momentum with Buvidal and Brixadi, expanding their reach and impact across key regions.

Importantly, the first of our new wave products, Oclaiz, received regulatory approval for acromegaly in both EU and the UK. Supporting our strategic expansion into the US, the commercial infrastructure is now firmly established, positioning the company for upcoming launches and long-term success in this critical market.

During the year, we also entered a strategic license agreement with Lilly, opening new opportunities in the long-acting incretin therapy space. The year also marked substantial improvements in sustainability performance, evidenced by high external ratings and reinforcing our commitment to responsible and sustainable business practices.

As a testament to the performance of our teams, full-year revenues for 2025 continued their positive trajectory, reaching 2.3 billion SEK. At the same time, profit before tax increased to just above 0.9 billion SEK, accomplished while maintaining significant investments in R&D and expanding the US operations.

In the fourth quarter, results demonstrated a balanced performance with an overall positive conclusion for the year. Brixadi royalties in the US showed strong year-on-year growth of 47% and increased 82% at constant exchange rate.

Buvidal sales declined temporarily due to FX headwinds and a change in our UK distribution model. The launch of Oclaiz in Germany represented a notable milestone as it is the first European country to introduce this product to patients with acromegaly.

Turning to R&D, we resubmitted the NDA for Oclaiz, which the FDA now has accepted with a PDUFA date in June. Additionally, we reported compelling Phase 1b results for CAM2056.

[speaking

Thank you. Camurus reported quarterly revenue of 464 million, down from 553 million, a 16% decline compared to the same period last year, while quarterly product sales reached 342 million, reflecting a 27% decrease.

This reduction is primarily due to a change in the UK distribution model. Consequently, we repurchased 93 million worth of inventory from our UK wholesaler.

Quarterly royalty income from Brixadi sales in the US increased by 47% year-on-year, reaching 122 million. A potential milestone payment from Braeburn relating to Brixadi sales is now expected in 2026.

Full-year revenue raised to 2.27 billion, up from 1.87 billion, representing a 21% growth or 30% at constant exchange rates. Product sales increased by 6%, while the Brixadi royalty income increased by 87%.

When reviewing operating costs, marketing and distribution expenses decreased by 12% during the quarter, but increased 7% over the year. The annual increase was mainly driven by the commercial rollout of Buvidal in Europe and Australia, as well as company's expansion in the US.

In R&D, we observed a 25% reduction in costs during the quarter and a 24% reduction for the full year. This reduction results from the completion of clinical trials in CAM2029 and CAM2056, with new trials scheduled for 2026.

Some costs related to the SORENTO study have been deferred to 2026. The increase in general administrative expenses is primarily due to a change in Camurus' internal cost allocation model.

Additionally, we have boosted our investment in digitalization throughout the organization. The operating results for the quarter decreased 32% to 113 million, while the full-year results increased with 86% to 874 million.

Buvidal sales and Brixadi royalty income mainly drove the increase. Looking at the quarter's cash flow, the cash position increased by 211 million, mainly driven by the operating activities, which contributed 111 million, and a change in working capital adding 144 million.

Investments reduced cash by 46 million, resulting in a net cash position of 3.7 billion, a 30% increase from previous year. Moving to 2026 financial guidance, the key considerations for the guidance are: anticipated market dynamics and competitive developments, pricing conditions and the reimbursement landscape, clinical progress and regulatory outcomes, and not least the current macroeconomic uncertainties.

We expect an increase in OPEX to be primarily caused by organizational expansion and increased R&D activities. An additional 200 million will be allocated to expand US operations in preparation of the planned Oclaiz launch mid-2026.

R&D expenses are expected to increase by roughly 150 million. We provide guidance on revenue and profit.

We have shifted from reporting profit before tax to operating results. Revenues consist of product sales, including royalties and milestones.

Potential license income from new and existing development partners are not included. Our full-year 2026 outlook is as follows: revenue guidance is 2.6 to 2.9 billion SEK, an increase of approximately 21%; operating results in the range of 0.9 to 1.2 billion SEK, an increase of approximately 20%.

The numbers are reported or measured at constant exchange rates. With that, I would like to hand over to Richard.

Thank you, Anders. I'll start with Camurus markets.

As already stated, invoiced sales were impacted due to a one-time accounting adjustment associated with a change to the UK distribution model at the end of the period. Importantly, though, across markets, the underlying in-market growth remained solid, growing at 5% quarter-on-quarter with notable performances from Australia, which continues to grow from a high base, and Buvidal is maintaining its leadership position in the long-acting buprenorphine segment; in the Nordics, where Buvidal continues to gain market share, which was increased by the competitor withdrawal from the market; and the UK showed improved growth mainly from the criminal justice system as NHS England funding is reaching those treatment centers.

On a full-year basis, overall growth was 17% at constant exchange rate versus 2024, with the growth spread across geographies. Those markets with high Buvidal penetration, such as Australia, the Nordics, grew at 15% from their high bases.

A positive contribution was achieved from the larger European markets that have lower penetration due to access issues. These markets grew in the region of 21%.

At the end of '25, there are an estimated 70,000 patients currently in treatment with Buvidal, a net gain of 3,000 patients in the quarter. There remains a significant growth opportunity for Buvidal, and notably in those larger European markets.

As already mentioned, in countries where funding and access hurdles have been addressed, penetration is high. In Australia, Nordics, Scotland, and Wales, Buvidal share ranges from 26% to 70% with an average of 35% of all patients, and we expect continued growth in 2026.

In the larger markets where access is currently limited to Buvidal, Buvidal has gained single-digit share of patients in treatment, represents a significant opportunity when the funding and infrastructure issues are addressed. In England and France, the main challenge remains the prioritization for funding in this area.

In Spain and France, there are restrictions on Buvidal access, either which patients are approved for treatment or limitations on the treatment setting where Buvidal can be prescribed. We achieved a notable success in Q4 where we reached agreement in Spain with the Spanish Ministry of Health to remove restrictions on the patient populations for Buvidal, allowing access to the large methadone segment.

In Germany, physician remuneration remains the hurdle. Additionally, we continue to expand geographically in other markets where our focus is penetration to deliver double-digit growth in 2026.

Now to address the access challenges in these high-potential markets, the teams are focused and delivering on critical policy affairs programs that call for and drive improved patient access. On the next slide are some examples of the outcomes already achieved from these programs and the growing support from across stakeholder groups for broader access to long-acting injectable buprenorphine and which we expect to drive growth in 2026.

Taking these in turn: in the UK, the Home Office Select Committee, the Justice Committee, the Independent Review on Drugs, and a recent report from the experience in Wales have all called for improved access to long-acting injectable buprenorphine. We are already seeing good access in prisons, though challenges remain in the community setting, and we have ongoing discussions with the Department of Health to address this.

In France, reports from both the Senate and the Assembly have similarly made calls for improved access, and some progress has been made in funding for Buvidal at both a national and a regional level. In Germany, again, there's wide stakeholder support from physician societies, patient organizations, and policymakers, such as the Drug Policy Group in the Bavarian Parliament, for change in the remuneration system to allow access to innovative treatments.

The progress on this is slow. However, it is understood that there are ongoing discussions on this topic with the regional and federal associations of physicians and the health insurers.

In Spain, as mentioned already, restrictions on patient access have now been removed. With this growing policy support for better access, we continue to work with payers to find ways to deliver on changes that will allow more patients to benefit from the advantages Buvidal brings.

Now moving across to the US, Brixadi continued its strong performance in the year with Q4 royalties of 122 million SEK, up 10% from previous quarter and 47% year-on-year. For the full year, Brixadi royalty grew 113% at constant exchange rate versus '24.

According to our estimates, Brixadi has captured at least 30% of the long-acting buprenorphine segment. In the US, the long-acting buprenorphine segment is now above $1 billion in annual sales.

Looking ahead to '26, continued market penetration is expected. The key areas of focus remain: conversion of patients from daily sublingual buprenorphine—note there are an estimated 2 million patients that access treatment on sublingual buprenorphine in a year; also improving access for patients outside of treatment or in the criminal justice setting; and Braeburn, our partner, continues to communicate the evidence base and the clear value proposition of Brixadi.

Overall, we remain optimistic about the prospects for Brixadi in the US and the potential for significant growth in the coming years. In parallel to this, we are preparing for the launches of Oclaiz in Europe, the first monthly subcutaneous octreotide medication that enables convenient self-administration for patients and enhanced octreotide plasma exposure.

The European launch has now been initiated in the wave one countries that have an estimated 4,000 to 5,000 acromegaly patients currently treated with first-generation SRLs. The response to Oclaiz from physicians and patients has so far been encouraging, with a positive view on the product profile and the clinical data, and market research shows a high willingness to switch to Oclaiz from current SRLs.

In our first launch market, Germany, we've seen a strong start with the uptake in the first month of launch an estimated 20 patients, which is about 1% share, and high patient engagement with the advantages of the simple self-administration. In addition, initial feedback from other payers has been favorable, and pricing is now approved in the UK and Norway, where we're now ready to launch.

With the resubmission of the NDA for Oclaiz, we're also gearing up, as Fredrik said, for the US launch mid-2026. The team is launch ready with a clear understanding of the market, a developed go-to-market strategy that includes market access, advocacy, and distribution plans.

During the review time of the NDA, we will take the opportunity to build the sales leadership, followed by the sales team's onboarding, and look forward to the execution of the launch plan if approval is granted. On this, I will hand back to Fredrik.

Thank you so much, Richard. I will continue with a brief summary of the R&D advancements in the fourth quarter.

Starting out with the progress in the octreotide depot program for acromegaly, gastroenteropancreatic neuroendocrine tumors, and polycystic liver disease. The overall clinical program for CAM2029 is nearing completion across indications.

We have successfully wrapped up the ACROINNOVA program, which delivered strong results from two pivotal Phase 3 studies and an open-label extension. In gastroenteropancreatic neuroendocrine tumors, SORENTO study is making solid progress and remains on track for reaching the critical readout of primary efficacy results in the second half of the year.

Additionally, the open-label extension of the POSITANO study continues to advance, following the achievement of positive results for the primary endpoint during the core phase of the study. Now moving over to development update by indication.

In acromegaly, we received significant milestones. Oclaiz, as we mentioned before, was approved both in the European Union and the UK in 2025, marking a major regulatory success in the year.

Following this, we launched Oclaiz in Germany in the fourth quarter, broadening out our commercial presence in Europe. Turning to the US, we resubmitted the new drug application for Oclaiz to the FDA on the 10th of December, after receiving green light from our contract manufacturer partner.

The FDA accepted this after the year as a Class 2 review, setting a PDUFA date target of 10th of June 2026, and positioning Oclaiz for potential US approval and market entry shortly thereafter. Moving over to GEP-NET and the ongoing Phase 3 study, as SORENTO is the largest clinical study to date for GEP-NET using a somatostatin analogue, directly comparing CAM2029 with current standard of care.

The study is progressing according to plan with a target of 194 progression-free events required to reach the primary endpoint readout in the second half of the present year. Importantly, compared with earlier trials with SSAs in this indication, SORENTO has enrolled patients with more advanced disease, including a majority of Grade 2 and Grade 3 neuroendocrine tumor patients.

As we await the results, our teams remain focused on robust study conduct, rigorous data cleaning, and maintaining the highest study quality to enable rapid and reliable topline result announcement. The upcoming results will represent a major milestone for Camurus, marking the culmination of nearly 5 years of patient treatment and study efforts.

Commercially, this represents a significant opportunity for the company, with global peak sales estimated around $2 billion currently. Finishing off with CAM2029 in polycystic liver disease, where we have in the process of completing the 30-month POSITANO extension phase, as mentioned before, our regulatory and clinical teams have prepared an end-of-Phase 2 meeting with the FDA, scheduled for March, to discuss the design of the pivotal Phase 3 study.

In summary, we achieved significant progress with 2029 across the three indications, and we anticipate an eventful period ahead. Moving over to the early pipeline, a clear highlight of the fourth quarter was the positive topline results from our Phase 1b study of the monthly formulation of semaglutide, CAM2056, in patients with overweight or obesity.

This study featured a randomized comparison to the current weekly semaglutide formulation, as well as dose escalations. The results exceeded our expectations and showed that CAM2056 achieved faster and greater reductions in body weight and blood glucose compared to Wegovy, with a similar safety and tolerability profile up to the highest dose.

This slide summarizes the Phase 1b study design for CAM2056 with the five dosing regimens across 80 patients using both randomized and dose escalation parts. The study allowed us to compare directly against weekly semaglutide and to define the optimal initiation and titration strategy for a monthly formulation.

On the next slide here, as you can see, CAM2056 delivered substantially greater reductions of body weight and A1C compared to the weekly semaglutide over the treatment period. By Day 85, that is after 3 months of treatment, Group 4 achieved a 9.3% weight reduction with CAM2056 versus 5.2% with weekly semaglutide dosed according to label, and A1C declined by 0.44% versus 0.12%, which is in the significant clinical domain.

The data clearly demonstrates the potential of FluidCrystal-based formulation of semaglutide. Going forward, our next steps will be to build on the promising Phase 1b results.

We are actively preparing for a Phase 2b study planned to begin the second half of the year. In parallel, our R&D teams are preparing the final product presentation, which will feature a new autoinjector pen device to enhance dosing convenience for patients.

The positive outcomes from the study not only support continued development of CAM2056, but also provide strong validation for the FluidCrystal technology platform. As such, these results reinforce the potential of using FluidCrystal technology for additional long-acting incretins, as well as other peptide-based therapeutics, including in our ongoing collaborations with Lilly and the partnership, the new partnership with Gubra.

With this, it's time to wrap up with some final comments. I think we can say that 2025 was a year where Camurus made significant progress with major R&D milestones, solid growth, and high profitability.

This year, we aim to—this year, with that I mean 2026, we aim to expand our market leadership in opioid dependence treatment; launch Oclaiz for acromegaly in Europe and the US, pending, of course, FDA approval; and move SORENTO to positive data readouts. New clinical trials will also begin for promising candidates like CAM2056.

For further growth and diversification of our business, we will invest in our partnerships, intensify business development to secure new collaborations and potential strategic acquisitions. Our solid financial, operational, and scientific base gives us a clear path to sustainable value creation, and we are well positioned to make 2026 a transformative year.

With that said, I will thank you all for listening, and let's move over to Q&A.

Hi, all. Thank you so much for the presentation.

Two questions, if I can. The first, in the annual report, it says that the core component phase of the SORENTO trial is now set to be completed in H2 '26.

Can you clarify what this core component is, and is the topline data still then estimated for mid to late 2026? The comments on the new autoinjector pen device, can you provide any more color on this?

Is this just for the CAM2056 asset? Thank you.

Thank you, Romy. With the core phase, we mean the randomized part of the study, to the point where we can start reading out the data.

As to the injector, autoinjector for CAM2056 that we are working to develop, we have been working with this for quite some time, and it will be a new device adapted specifically for CAM2056.

Clear. Thanks so much.

Does that answer your questions?

Yes, it does. Thank you.

Thank you.

Hi, guys. Gonzalo Artiach from Danske Bank.

Thank you for taking my questions. I have a couple of them.

The first one, I'm trying to understand the FX impact, especially in the US. Could you give us some color on FX impact that you see there in the US?

Peak-to-trough is 17% headwind, if I understand correctly, on USD to Swedish crown. How do you end up with 35% headwind?

The second question is on your 2027 goals. Have they changed based on how 2025 closed?

I see that you guys still target 100,000 patients with Buvidal, but do you have any words on margin development? Are you still targeting around 50% for 2027?

Anything on topline goal for that year would be appreciated. Thank you so much.

I think I'll leave the first question over to Anders when it comes to the dollar rate and its impact on our FX rates.

We have had a lot of fluctuation in the currencies during the year, primarily in the Australian dollar and the US dollar, as you state. It all depends on when we book.

It's more a technical thing when you book the invoices and so on, that's where you see the effect. We have seen a decrease over the year from January all the way to December, yeah.

Gonzalo, can you repeat the second question?

Yes, it's on your 2027 goals or targets that you have disclosed in the past. What do you have to say in terms of your margin approach?

Are you still targeting around 50% your EBIT margin? On topline, any words on that also?

We established the vision for 2027 in 2022, and we're working decisively and with a high dedication to achieve that. Obviously, there is still a ways to go, but we maintain our goals currently, including the margin goals of approximately 50%.

Perfect. Thank you.

I want to highlight that this is and remains a vision for the company.

Hi. Sorry, my question's already been answered.

Thank you so much.

Yes. Hi, there.

Thank you for taking my questions. My first question is just to what extent your guidance range might reflect any concern about ongoing FX headwinds, because obviously it was a headwind for your '25 delivery, and you cut the guidance partly as a result.

Obviously, it's only going to get worse, you're fighting with one hand tied behind your back. That's my first question.

Thanks.

Anders, do you want to comment on?

We have definitely taken the currency exchange risk into consideration when providing the guidance. Then we have made a thorough analysis on several expectations for the development.

Also, I would say, when we look into the US, this year we've predominantly have income. Next year we'll also beginning to have some expenses because of the build-up.

Now it's been more a natural hedge. Of course, we are very much exposed to the US dollar.

Thanks. That was the first one.

Secondly, I noted that you had mentioned the milestone from Braeburn in 2026. Is it fair to assume that that's in guidance?

Can you give us an indication of the size? Is it similar to the last one you got from them?

Good question. Obviously, we did not realize the milestone in 2025.

There are good reasons to expect the first milestone. We haven't received any sales milestones yet from the collaboration, but there are good reasons to expect it in 2026.

The size, you could say, I don't think we have given any exact size. It's the smaller of the three.

The total amount is $75 million.

Great. Thanks.

That's helpful. Then my next question is on SORENTO, is it likely to be in the early or late second half at this point, do you think?

I think there is still some uncertainty about that. It depends on the accrual rates month by month and quarter by quarter.

Of course, it's very difficult because it's an event-driven trial. It's very difficult to give exact predictions, and it may vary between how patients were enrolled.

We have, of course, our models, but they do give quite a big, wide interval still. We will get some more updates here, of course, in the early part of the year.

The more data we get, the better we are able to give an idea about when exactly we can close and start to read out data.

Thanks very much. Those are my sort of housekeeping questions.

Then I have a question on revenue per patient, because last 9 months, you can see a dip for Buvidal of about 25%, it looks like. How much of that is actual price pressure versus FX?

Thank you. I have other questions if it's okay.

I'll leave it over to Richard to explain.

The first answer is the price is pretty stable across our markets. We're maintaining that without a problem.

There is obviously a country mix depending on the volume there, because there are different prices in different markets, and then the rest will be down to FX.

Okay. Thanks.

All right, then I guess just if you could, is there a little bit more you can give us in terms of what's going on in the UK and Germany in terms of the status and France, I should say? You did comment a little bit, but do you have any hints on whether momentum is gathering, let's say, for Germany, for example, with remuneration reform?

Thanks.

Yeah. Sure.

Very good questions. I'll start with Germany then, as the one you mentioned there.

As I said, there's quite a lot of support for change in this remuneration system. It's something that we cannot be involved with as an organization, but we understand there is ongoing and advancing discussions between the both national and federal physicians associations and the health insurances to change that, they can open up access.

There was a report came out of the Drug Strategy Group of the Bavarian Parliament calling for the same thing. I think there's growing momentum there.

It's a bit unsure how we can say when the outcome will come, but we know there's ongoing discussions. For the UK, to answer the question there, we know Wales and Scotland are going very well.

They have high penetration, they have funding available. England is our challenge.

Again, there's clear demand from across many groups, as I said, from criminal justice, from healthcare, from healthcare professionals, and patients to have funding. We've seen the NHS England, who are responsible for treatment in prisons, making a significant commitment to funding that started mid this year, mid-'25, and is continuing, and hence we're seeing the growth we're seeing in the UK coming mostly from prisons.

We know the UK government have now announced a 3-year funding settlement for public health, including a ring-fenced proportion for opioid dependence treatment. We're in dialogue with the Department of Health, NHSE, and other stakeholders to identify ways that funding can be allocated to long-acting buprenorphine to meet the demand that's there.

That's very helpful. Is it possible to kind of give us gating events that remain for these things to happen in both Germany and UK and France?

Specific events that so we

I think that's very difficult. This is policy change, and the remuneration, we're not involved in that, it's very hard to be able to judge when the timing on those things are.

I appreciate that. Thank you very much.

Those are my questions.

Thanks.

Yes. Thanks for taking my questions.

Continuing maybe on the UK, I guess this is perhaps the main uncertainty going into 2026. Can you give a bit more insights into if there's any stocking left at distributors that could impact sales here in 2026?

Just remind us maybe when funding is expected to trickle down to clinics to improve the sentiment in the UK? Thanks.

Sure. There's no more stocking in the channels, to answer that one quickly.

The NHS year runs from April to March. The latest announcement from the government will come from April.

How long that will take for the funding to reach the clinics is a moot point. We know that this year there was an announcement, and it's been very slow in reaching the clinics, which is one of the reasons that it's been a bit slower than we anticipated after the announcement.

We're obviously doing everything we can to encourage responsible people to make that available to patients as soon as possible, because there is a clear unmet need, and patients are waiting to go onto treatment with Buvidal.

Okay. Maybe it's more towards the end of 2026 or second half, is that fair?

I don't think we can say that now. I think if there is potential it could come.

We know there's been a delay in '25, and people are putting pressure on that, it could come earlier.

Okay. Just on guidance also, could you specify a bit more what you mean with pricing conditions and reimbursement as something that could impact guidance both on the upside and downside?

What the most important points here is also in the US here to keep in mind when you talk about competitive developments that you mentioned in your guidance?

When it comes to pricing, of course, it is our current understanding of the pricing landscape, both for of course, most importantly, for Buvidal and Brixadi. We don't see that there are big differences from year to year, at least not from 2025.

It's relatively stable landscapes there. When it comes to Oclaiz, we don't have that many uncertainties either because we got the approval, of course, in Germany of the price, and we have proceeded now with Norway and other markets.

I think that's what we mean. We're building it on our current understanding of the pricing situation and reimbursement willingness in our different markets.

Okay. I just had a final one also on FluidCrystal, maybe in general.

You have had a lot of data pointing to that FluidCrystal also enhances existing drugs' bioavailability in your trials. I guess we saw evidence of this again in your trial with semaglutide.

Have you done any more analysis on that, on your semaglutide data, supporting that bioavailability is higher with FluidCrystal and enhanced semaglutide versus Wegovy? Do you expect this efficacy advantage to be sustained in your next trial?

Do you get both, yeah, long-acting, but also increased efficacy here for this product? Also maybe related there, what would be the difference here in the Phase 2b trial?

Is it just more patients or any other key changes that we could expect? Thanks.

That's a really good question. I don't think we have talked about bioavailability specifically.

What we referred to was that we had the same Cmax concentration at a much higher dose with CAM—well, at a 4 times higher dose with CAM2056 as the now approved product. We have obviously done a lot of analysis on the relationship between our different variables in the study and time, and so forth.

Going to the Phase 2b study, the main question will be to see how the weight reduction is developing over longer period of time. It will be a significantly longer study.

We will also look at some details around the dosing mechanism, although we have now identified what we believe is the optimal dosing regimen. We will definitely produce new data that will be presented in various different settings on the PK/PD and relationships.

For the specific question about the study, it will be a longer study and it will be a controlled study in the first case. Then in parallel with that, we'll do the Phase 3 preparation developments.

Okay. Thanks.

That's very clear. Thank you.

Yes, hi. A couple of questions on my side.

The first one maybe on the guidance for 2026. Could you give us a bit more granularity on your expected contributions from Buvidal, Brixadi, and Oclaiz in this guidance?

As we said in the report, we're expecting Buvidal to continue to grow in the region of what we saw in 2025. I think that's clear.

We also have a view that we're expecting good performance from the US and Braeburn with the Brixadi development. That's, of course, a very important component of the development, or the expected development for 2026.

I think we have to say that Oclaiz, of course, is going to be launched in a few markets, but it's going to be early in the launch cycle compared to the developments that we have, of course, for in the opioid dependence area. The contribution there will be low, and I think you should focus on the big components.

Then, of course, we have excluded any potential revenues from ongoing development programs. They are, as always, digital.

We thought it was better to leave them out. There is, of course, the potential of some upside in that range.

Thank you. Then another question.

You mentioned your objective of 100,000 patients in Buvidal by the end of '27. This would obviously mean a strong acceleration in the next 2 years, maybe higher than what you've shown in the past.

My question is, where will this growth come from? Are you already seeing some signs of acceleration in Europe, for example?

I'll leave that to Richard.

Yes. As I said, we saw growth of 20% plus in the big European markets, Germany, UK, France, and Spain.

That's the big opportunity here. We're working very closely with a whole group of stakeholders to try and improve access here.

Some of those could be quite material if successful, that will give access to many more patients. That's why we believe the 100,000 is still possible in that time, but it is predicated on solving some of those funding challenges that we're facing, which we're making good progress in doing.

Thank you. Just one last question.

What is currently the proportion of Buvidal sales that are coming from the UK? I don't know if you've already disclosed this or not.

I don't think we have disclosed it, and we're typically not giving the relationship between different markets.

Okay. That's all for me.

Thank you.

Hi, this is Georgios from ABG. I have a couple of questions as well.

First, I'm wondering if you can give any insight to where the German patients adding roughly 20% year-on-year growth are coming from. Then secondly, regarding Oclaiz, when do you expect to launch in France, Spain, and Italy?

Thank you.

The first question you had, was that regarding Buvidal?

Regarding what kind of German patients I'm getting or adding at the moment at the

year-on-year

growth 20%, yeah. Okay.

I'll leave it to Richard.

Yes. It's a mix.

There's patients in the criminal justice setting that are outside the remuneration challenge, which we see growing. There are other physicians who are more open to prescribing a long-acting in the community setting, and it's coming from there.

It's a mix. I can't say there's one specific segment more than the other.

Prisons is key, but also so is the community setting.

When it comes to the other question, we're starting in the wave one countries. In parallel, we are doing our market access work for the rest of Europe.

We will kind of announce, as you have seen for Buvidal, we have added countries now we are in our seventh year, and we are still adding new countries in the markets. I wouldn't say that we are expecting to see France on board, for instance, until, at the earliest, next year.

Yes. Great.

Thank you.

Thank you so much.

Hello, just two more questions from my end. One would be if you could share any comments with regards to your communication with Eli Lilly.

Is that frequent, on a monthly basis, for instance? Are they happy with the data?

The second question would be just on the inventory there that you got back for the UK. How long is the shelf life for that, or can you reallocate that to other geographies if the UK would take more time?

Thank you.

On the first question, I have to say that, through our contractual relationship with Lilly, we are not able to communicate too much about the progress. On important things that are material to the company, we will progress and communicate.

I think the information that is available now is what we can say about the current state of that collaboration. On the second question, Anders?

We can definitely sell that product continuously. There's no question about that.

That's very simple reply to that one.

We have 36 months shelf life on the product, typically that's not a problem for us.

Perfect. Thank you.

Thanks so much for taking my questions. I have two.

I'm coming back to this 100,000 patient target. With the net additions of 30,000 required to get there, should we think of net patient wins as linear from here or should we think of them rather as back-end loaded as more and more reimbursement hurdles are removed?

Then secondly, for the vision of revenues of 4.5 billion krona for 2027 shared back at the CMD in 2022, at the time, the composition was 3 billion krona from Buvidal and 1.5 billion krona from pipeline. When I look at these from consensus, it's largely at the 4.5 billion krona level, but the composition is different: 2.6 from Buvidal and 1.9 from pipeline.

I'm curious to hear if you have any feedback or thoughts on that composition, not least in light of some of the pipeline contribution being delayed due to CDMO's inspections, as well as slower crude events in the SORENTO trial. Thanks so much.

Okay.

I'll take the first one on the pick up of patients. I don't think there's a clear answer on this one, because it depends on when we achieve the funding.

Yes, obviously, it's more likely to come later as we get there. We're in quite advanced discussions with some areas that we could move more quickly.

That would depend on some changes that we need to make in discussions with the stakeholders involved in this. I don't think there'd be a clear answer on that.

We do see also that we have a contribution for the expansion into new markets. Some of them have responded relatively slowly, like Portugal, but we do see significant growth opportunities.

It's a mix there. Far, we have been quite linear, as was shown in the figure here earlier.

We need to pick up some more patients to reach the 100,000 by the end of 2027, for sure. The 4.5 billion, yes, the mix, obviously, in 5 years, things happen in terms of the different programs advancing.

We have maintaining our ambition. You see basically how Buvidal is evolving, and the contribution can be closely to where we were expecting it.

We have uncertainty to how quickly the Brixadi sales will continue growing. We are hopeful there, of course.

Those will be two major contributions. The delay in SORENTO in the trial or not trial execution, but in the event rate, may have an impact, and in that case, to reach the goal, we will need to add additional revenues.

On top of this, of course, we also have a number of milestones that can come in in 2027. I would say, overall, we are not that far from the distribution that we mentioned in the 2022 CMD.

Obviously, we weren't exact, and we will not be exact.

That's helpful. Thanks so much.

Yes. Hi.

Thanks for taking my questions. The first is what drove your decision to change distribution model in the UK, and what impacted the timing of the decision, i.e., why now?

My second question relates to Oclaiz and the 20 patients that you have on therapy in Germany. Is this mainly switch patients, or are you also getting naive patients?

Where do the switches come from? Is it both Sandostatin and Somatuline, or mainly Sandostatin switches?

Thank you.

I'll leave the first question to Anders.

It came out from the volatility in the UK market. That caused us to more or less aligned the UK model with the rest of our distribution strategy.

That's why we went to a different model. Also because we have the upcoming launch of Oclaiz.

Then also, when I look to the future accounting principles, how you report, especially IFRS 15 and 18, then this model is much more suited for us. That was why we did it.

It made sense to do it by the end of the year, it was very clear.

On the Oclaiz patients, I would say that all of them were switches from both treatments. We should, of course, be aware that there was only basically little 1 and 1/2 month or so recruitment time since the launch and availability of product in the market.

I think we saw good pick up in that time period. The positive note is that most patients in Germany are on treatment, there are many fewer coming in new patients per month or per time period.

This is a very good signal for us. It seems to be progressing nicely also into the early part of this year.

We are happy with that. I think you should assume that most of our patients will come from switches of current treatment.

All right. Great.

Then just a follow-up on Brixadi. Do you expect a similar pattern in Q1 of this year as last year when the buprenorphine market declined by double digits in Q1 versus Q4?

I think that there is a change now because, obviously, we had the whole situation with the change from the COVID times that we saw impacting the 2025 first part, because there were still patients that hadn't had to be exposed to getting new allowances for prescriptions. I don't think that that dynamic is left there, we expect to see less of a dip in Q1, if any.

I don't have that information, but I think that's the situation.

All right. Thank you so much.

Yes. Hi.

Thank you. It's one on PLD.

Could we assume that you guys will start a Phase 3 this year if you have the end of Phase 2 meeting now in March, if I heard correctly? If so, is this baked into guidance?

Thank you.

The important thing here is, of course, we are seeking the agency's advice on the study design of the PLD study. Should we get perfect alignment with them in the first meeting, then there's definitely a probability.

Even so, I wouldn't say that it would impact our R&D costs significantly, and they are baked into the current expectations or financial results expectations.

Thank you.

Yes. Thank you for taking my follow-ups.

Two, if I may. The first, just one clarification on the UK funding, is there any kind of clawback or rollover on the funding that was allocated for '25?

If there would be a rollover, how would that impact 2026's funding allocation? Thank you, for the first one.

I think there's unlikely to be a rollover, but there is new funding for '26 announced a couple of months ago now. Of which some of it the public health grant that goes to all sorts of distribution amongst public health requirements, and some of it has been ring-fenced specifically for treatment of drug and alcohol.

Great. That's helpful.

Then the second question is on the runway remaining in the EMEA region, and I guess within that also particularly Australia. How much more penetrated can long-acting injectables get in those markets?

Thank you.

I think there's still a reasonable opportunity. There's still reasonable numbers of patients on sublingual that many of whom will benefit from moving to a long-acting.

There's also the methadone segment, and we're seeing increasing demand from patients to move to a long-acting treatment from methadone. It's a harder transfer, but the experience that people are gaining and how to do that is growing all the time.

We're seeing firstly demand growing, and also the numbers of patients moving away. In Australia, for example, we're seeing methadone gradually decline, but there's still, we have 35% something in the region of 35% share for long-acting, so that means there's 65% of people still available.

Some of those will want long-acting.

I think we have said earlier that we believe that we could ideally or even potentially exceed that, but long-acting injectables could reach up to 50% share, and so there is significant growth opportunity left in our view. We'll see how it's continued developing very well in 2025, and we haven't seen any signs yet that that will be stopping.

Great. Thanks so much.

Hey. Thank you for taking my questions.

I've got three, if that's okay. Could I actually just press you on what the guide actually bakes in for Brixadi growth in 2026?

I know it was asked before, but could you perhaps compare that to how Brixadi performed last year and what we would look like, the momentum in 2026?

I think what we said is we are believing that Buvidal will continue to grow in a steady fashion. The remainder of what is baked in should be essentially Brixadi growth according to our projections.

Understood. Thank you.

Then

my next question, please, is with the end-of-Phase 2 conversation that you have with FDA in March for the PLD indication, where does that place potential Phase 3 start, and therefore, the timing of the costs for that study?

Importantly, it depends, of course, on which response we get from the agency. Starting up a Phase 3 study and having the first patient treated, it typically takes at least 9 months and probably a little longer than that.

Understood. Makes sense.

Then just my final question, please. Could you just clarify the England funding situation?

There's funding that was meant to well from last year, that was meant to arise, that never hit the clinics. When is that expected?

Then you said is there another round of funding that could come or be communicated by April, that would then hit in 2H? Could you just clarify the timing of the funding?

Yeah. There's three sources.

Firstly, the NHS England funding for prisons, which is reasonably significant, is already in place in clinic and is driving growth in the UK. The broader community-based funding, that's the bit that struggled to come through.

We don't know really what's going to happen in Q1, but what we do know is from Q2 onwards, from April when the NHS year starts, there is this new committed funding by the government for public health, of which a large proportion is allocated specifically to drug and alcohol addiction. We anticipate that coming in.

We anticipated last year as well, and it didn't reach it, we'll have to wait and see. I think the call for access to long-acting buprenorphine is very clear from various sectors, and I think we're confident that it's going to come through in 2026 at some time.

All right. Thanks so much.

That's all.

Hi, thanks. Just one follow-up from me.

Can you please provide some more color on your M&A and BD priorities for 2026? Is there any specific criteria or areas that you are looking at?

Thank you.

Nothing has really changed from previous year. We are looking, as I said, for mainly our target is pre-commercial, commercial assets that are synergistic to our current business in Europe, US, or the more global settings.

That's the main target for us. That would be in endocrinology, rare oncology, potentially other rare disease indications, and CNS.

Then we are working more exploratively, of course, also with early potential developments, including licensing transactions and early licensing just to fill the early pipeline. I would say, our core focus is on late-stage opportunities, as mentioned earlier.

Great. Thank you so much.

Thank you, everybody. I think and hope you see that we have a solid foundation for the year to come.

I look forward to updating you all together with the team on our Q1 presentation and meet you in between. Thank you very much for listening in and asking very insightful questions.

Thank you.