Camurus Ab

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. So 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 the key takeaways and Q&A. With me in the call today is Anders Wadsholt, Chief Financial Officer, and Richard Jameson, Chief Commercial Officer. So a quick overview of CAMERAS. 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 fluid crystal 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 continue to build momentum with Buvilar and Brixadi, expanding the reach and impact across key regions. Importantly, the first of our new wave products, Oxyisa, received regulatory approval for acromegaly in both the 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 to 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 U.S. operations. In the fourth quarter, results demonstrated a balanced performance with an overall positive conclusion for the year. Brixari royalties in the U.S. showed strong year-on-year growth of 47% and increased 82% at constant exchange rate. Bubidal sales declined temporarily due to FX headwinds and a change in our UK distribution model. The launch of Oxuisa 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 Oclase, which the FDA now has accepted with a PDUFA date in June. additionally we reported compelling phase 1b results for camp 2056 and our strategic collaboration with lily advanced to plan financially we delivered solid profitability strengthened our cash position giving us increased financial flexibility and lastly we entered a new licensing and commercialization partnership with gubra in denmark adding another promising asset to our endocrinology pipeline. So with this, I will hand over to Anders to take you through the financial performance of the quarter and of the full year.

Thank you, Fredrik. Well, I'm pleased with the financial performance during the year. The figures I refer to in my presentation on Swedish kronor. ChemRex 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 Bricsati sales in the US increased by 47% year-on-year, reaching $122 million. A potential milestone payment from Braeburn relating to Bricsati sales is now expected in 2026. Full-year revenue reached $2.27 billion, up from $1.87 billion, representing a 21% growth. or 30% of constant exchange rates. Product sales increased by 6%, while the Bixati 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 Buvedal in Europe and Australia, as well as companies expansion in the US. In R&D, we observed a 25% reduction in cost during the quarter and a 24% reduction for the full year. This reduction results from the completion of clinical trials in CAM 2029 and CAM 2056 with new trial schedule for 2026. Some costs related to the Sorrento study have been deferred to 2026. The increase in general administrative expenses is primarily due to a change in Camurio's internal cost allocation model. And definitely, we have boosted our investment in digitalization throughout the organization. The operating result for the quarter decreased 32% to $113 million, while the full-year result increased with 86% to $874 million. Ubedale sales and Brickside 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. Investment reduced cash by $46 million, resulting in a net cash position of $3.7 billion, a 30% increase from previous year. Moving to the 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 outcome, 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. additional 200 million will be allocated to expanding u.s operations in preparation of the plant or blaze launch mid-2026 and 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 licensed 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 SEC, an increase of approximately 21%. Operating results in the range of 0.9 to 1.2 billion SEC, an increase of approximately 20%. The numbers are reported or measured at Constantine Strange Street. With that, I would like to hand over to Richard.

Thank you, Anders. So I'll start with Cameras Markets. As already stated, invoice 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 remains solid, growing at 5% quarter-on-quarter, with notable performances from Australia, which continues to grow from a high base, and Buvertal is maintaining its leadership position in the long-acting buprenorphine segment. And in the Nordics, where Buvidal continues to gain market share, which was increased by the competitive 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 four-year basis, overall growth was 17%, a constant exchange rate versus 2024, with a growth spread across geographies. Those markets with high buvidal penetration, such as Australia, the Nordics, grew at 15% from their high basis. 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%. And at the end of 25, there are an estimated 7,000 patients currently in treatment with Buvedal, a net gain of 3,000 patients in the quarter. There remains a significant growth opportunity at Buvedal and notably in those larger European markets. As I already mentioned, in countries where funding and access hurdles have been addressed, penetration is high. In Australia, Nordic, Scotland and Wales, Buvedal 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 Bouvadal, Bouvadal has gained single digit share of patients in treatment, so represents a significant opportunity when the funding and infrastructure issues are addressed. In England and France, the main challenge remains the prioritisation for funding in this area. In Spain and France, there are restrictions on Bouvadal access, either which patients are approved for treatment or limitations on the treatment setting where Bouvadal 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. And 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 challenge access challenges in these high potential markets, the teams are focused and delivering on critical policy affairs programmes that call for and drive improved patient access. On the next slide are some examples of the outcomes already achieved from these programmes and the growing support from across stakeholder groups for broader access to long acting injectable buprenorphine, which we expect to drive growth in 2026. So take 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 Boomerdale at both a national and a regional level. In Germany, again, there's wide stakeholder support from physician societies, patient organisations 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 Boverdale brings. Now moving across to the US, BrickSardi continued its strong performance in the year, with Q4 royalties of 122 million sec, up 10% from previous quarter and 47% year on year. For the full year, Brixardi royalty grew 113% at constant exchange rate versus 24. According to our estimates, Brixardi has captured at least 30% of the long-acting buprenorphine segment. In the US, this segment, the long-acting buprenorphine segment, is now above 1 billion in annual sales. And 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 Braeber and our partner continues to communicate the evidence base and the clear value proposition of BRICS-ADI. So overall, we remain optimistic about the prospects for Bixardi in the US and the potential for significant growth in the coming years. And in parallel to this, we are preparing for the launches of Oxasa 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 four to five thousand acromegaly patients currently treated with first generation SRLs. The response to Oxazer 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 Oxazer from current SRLs. In our first launch market in Germany, we've seen a strong start with the uptake in the first month of launch and estimated 20 pensions, 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. And with the resubmission of the NDA for Occlays, we're also gearing up, as Frederick 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 teams onboarding, and look forward to the execution of the launch plan if approval is granted. And on this, I will hand back to Frederick.

Thank you so much, Richard. I will continue with a brief summary of the R&D advancements in the fourth quarter. So starting out with the progress in the Octrutide Depot program for acromegaly, gastroenteropancreatic neuroendocrine tumors and polycystic liver disease. The overall clinical program for CAM 2029 is nearing completion across indications. We have successfully wrapped up the AcroEnova program. which delivered strong results from two pivotal Phase III studies and an open-label extension. In gastroenteropancreatic neuroendocrine tumors, the Sorrento 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. Oxuisa, 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 Oxuisa in Germany in the fourth quarter and broadening out our commercial presence in Europe. Turning to the US, we resubmitted the new drug application for Oclase to the FDA on the 10th of December, after receiving green light from our contract manufacturer partner, and the FDA accepted this after the year as a class two review, setting a PDUFA date target of 10th of June, 2026, and positioning Oclase for potential US approval and market entry shortly thereafter. Moving over to GEPNET and the ongoing phase three study. As you know, Sorento is the largest clinical study to date for GEPNET using a somatostatin analog directly comparing CAM-2029 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 top-line result announcements. The upcoming results will represent a major milestone for Camerus, marking the culmination of nearly five years of patient treatment and study efforts. Commercially, this represents a significant opportunity for the company, with global peak sales estimated around 2 billion US dollars currently. Finishing off with the CAMP 2029 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 two meeting with the FDA scheduled for March to discuss the design of the pivotal phase three 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 top line result 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 WeGOVI 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 monthly formulation. On the next slide here, as you can see, CAMP2056 delivered substantially greater reductions of body weight than A1C compared to the weekly semaglutide over the treatment period. By day 85, that is after three months of treatment, group four achieved a 9.3% weight reduction with Chem 2056 versus 5.2 with weekly semaglutide, dosed according to label. And A1C declined by 0.44% versus 0.12%, which is in a significant clinical domain. The data clearly demonstrates the potential of fluorocrystal-based formulation of semaglutide. And 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 in the second half of the year. In parallel, our R&D teams are preparing the final product presentation, which will feature a new autoinjector PEM device, to enhance dose inconvenience for patients. The positive outcomes from the study not only support continued development of CAMP2056, but also provide strong validation for the fluid crystal technology platform. As such, these results reinforce the potential of using fluid crystal technology for additional long-acting incretins, as well as other peptide-based therapeutics. including in our ongoing collaborations with Lilly and the new partnership with Gubra. So with this, it's time to wrap up with some final comments. And I think we can say that 2025 was a year where cameras made significant progress with major R&D milestones, solid growth and high profitability. This year, with that I mean 2026, we aim to expand our market leadership in opioid dependence treatment, launch Oxyisa and Oclase for Acromegaly in Europe and the US, pending, of course, FDA approval, and move Sorrento to positive data readouts. New clinical trials will also begin for promising candidates like CAM 2056. 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.

Thank you, Fredrik. The first question comes from the line of Romy O'Connor from Landshut Kempen. Please go ahead, Romy.

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 Sorrento trial is now set to be completed in H226. Can you clarify what the score component is? And is the top line data still then estimated for mid to late 2026? And the comment on the new auto injector pen device, can you provide any more color on this? Is this just for the CAM 2056 asset? Thank you.

Thank you, Romi. Well, with the core phase, we mean the randomized part of the study, so to the point where we can start reading out the data. And as to the injector, auto-injector for CAM 2056 that we are working to develop, we have been working with this for quite some time, and it will be a new device adopted specifically for CAM 2056. Does that answer your questions?

Yes, it does. Thank you.

Thank you.

The next question is from Gonzalo Artiach from Danske Bank. Please go ahead, Gonzalo.

Hi, guys. Gonzalo Artiach from Danske Bank. Thank you for taking my questions. I have a couple of them. The first one, I am trying to understand the FX impact, especially in the U.S. Could you give us some color on this, on FX impact that you see there in the U.S.? ? big two trough is 17% headwind, if I understand correctly, on USDA to crown, to Swedish crown. So how did you end up with 35% headwind? And 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 bovidal, Do you have any words on margin development? Are you still targeting around 50% for 2027 and anything on top line goal for that year would be appreciated. Thank you so much.

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

So we've had a lot of fluctuation in the currencies during the year, primarily in the Australian dollar and the US dollar as you state. So it all depends on when, you know, we book, it's more a technical thing, when you book the invoices and so on, that's where you see the effect. But we have seen a decrease over the year from January all the way to December. So, 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% of your EBIT margin and on top line? Any words on that also?

Yeah, so we established the vision for 2027 in 2022, and we are working concisively 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.

The next question comes from Pauline Hendriksen from Landshut Kempen. Please go ahead, Pauline.

Hi, sorry, my question has already been answered. Thank you so much.

Okay, thanks. The next question is from Kristoffer Ude from SCB. Please go ahead, Kristoffer.

Yes, hi there. Thank you for taking my questions. So my first question is just whether, you know, 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 And obviously, it's only going to get worse. So you're fighting with one hand tied behind your back. That's my first question.

Thanks. Anders, do you want to comment?

Yeah, so we have definitely taken the currency exchange risk into consideration when providing the guidance. And then we've made a thorough analysis on several know expectation for the for the uh development and also i would say when we look into the us this year we predominantly have income next year we're also beginning to have some expenses because of the build-up so so it's now has been a more natural hedge but of course we are very much exposed to the us dollar okay thanks that's uh 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. And the total amount is $75 million.

Okay, great. Thanks. That's helpful. Then my next question is on, so Sorrento, 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. I mean, it depends on the accrual rates month by month and quarter by quarter. And 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. So we will get some more updates here of course in the early part of the year. and the the more data we get the better we are able to give an idea about when exactly we can start to read out and close and start to read out data okay thanks very much those are my sort of housekeeping questions then i have a question on revenue per patient because last nine months you can see

a dip for BOOV at all of about 25%, it looks like. How much of that is actual price pressure versus FX? Thank you. And I have other questions.

I'll leave it over to Richard to explain.

Yeah, so I mean, the first answer is the price is pretty stable across our markets. We're maintaining that without a problem. So 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, so then I guess... 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, yeah, sure. I think good questions. I'll start with Germany then is the one you mentioned there. So yeah, I mean, 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 so they can open up access. And we've seen the growth. There was a report came out of the Bavarian, the drug strategy group of the Bavarian parliament calling for the same thing. So 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. And for the UK, there's a question there. We know Wales and Scotland are going very well. They have high penetration. They have funding available as England is our challenge. But again, there there's clear demand from across many groups, as I said, from criminal justice, from health care, from health care 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 over that that started uh the 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 three-year funding settlement for public health including a ring-fenced proportion for opioid dependence treatment So 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.

Okay, 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?

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

Yeah, I appreciate that. Okay, thank you very much. Those are my questions.

Thanks. The next question is from Victor Sundberg, Nordea. Please go ahead, Victor.

Yes, thanks for taking my questions. Yeah, 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? And just remind us maybe when funding is expected to trickle down to clinics to improve? sentiment in the UK. Thanks.

Yeah, sure, sure. So there's no more stock in the channels. I'll answer that one quickly. Then the answer, I mean, the NHS year runs from April to March. So the latest announcement from the government will come from April. How long that would 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. So we're obviously doing everything we can to encourage the 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 on to treatment with Buvidal.

Okay, so maybe it's more towards the end of 2026 or the 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 2025 and people are putting pressure on that, so it could come earlier.

Okay. And 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? And what the most important points here is also in the US here to keep in mind when you talk about competitive development that you mentioned in your guidance.

Yeah, 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 Brixari. And we don't see that, you know, there are big differences from year to year, at least not from 2025. It's relatively stable landscape there. When it comes to Oxyisa, I mean, 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. So I think that's what we mean. We are building it on our current understanding of the pricing situation and the reimbursement willingness in our different markets.

Okay and I just had a final one also on fluid crystal maybe in general you have had a lot of data pointing to that fluid crystal also enhances existing drugs bioavailability in your trials and I guess we saw evidence of this again in your trial with semaglutide but have you done any more analysis on that on your semaglutide data? supporting that bioavailability is higher with fluid-crystal-enhanced semaglutide versus VEGOVI. And do you expect this efficacy advantage to be sustained in your next trial? Do you get both long-acting but also increased efficacy here for this product? And 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 Or we had the same C-max concentration at a four times higher dose with CAMP 2056 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 a longer period of time, so it will be a significantly longer study. And we will also look at some details around the dosing mechanism although we have now identified what we believe is the optimal dosing regimen. So we will definitely produce new data that will be presented in various different settings. on the PK PD and relationships but for the specific question about the study it would be a longer study and it will be a controlled study in the first case and then in parallel with that we will do the phase three preparation developments okay thanks that's very clear thank you

Next question from Oskar Hafenlam from Stifel. Please go ahead, Oskar.

Yes, hi. A couple of questions on my side. The first one may be on the guidance for 2026. Could you give us a bit more granularity on your expected contributions from Bovidal, Brixari and Oxyessa in this guidance?

Yeah, I mean, As we said in the report, we are expecting Buviral to continue to grow in the region of what we saw in 2025. So I think that's clear. We also have a view that we're expecting good performance from the US and Braeburn with the BricsID development. So that's of course a very important component of the of the development or expected development for 2026. I think we have to say that Oxy-ESA, 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, in the opioid dependence area. So the contribution there will be low. And I think we should focus on the big components. And then, of course, we have excluded any potential revenues from ongoing development programs. And they are, as always, digital. So we thought it was better to leave them out. But there is, of course, the potential of some upside in that range.

Okay, thank you. Then another question. You mentioned your objective of 100,000 patients in Bovidal by the end of 27. This would obviously mean a strong acceleration in the next two years, maybe higher than what you've shown in the past. So my question is, I mean, where would this growth come from? Are we already seeing some signs of acceleration in Europe, for example?

leave that to richard yes i mean you as i said uh we we saw uh growth of 20 plus in the big european market so germany uk france and spain and that's the big opportunity here we 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 if successful that will give access to many more patients so that's why why we believe the hundred thousand is still possible in that time

but it is predicated on on some uh solving some of those funding challenges that we're facing which we're making good progress in doing okay thank you and just one last question um what is currently the proportion of pivotal sales um that are coming from the uk i don't know if you've already discussed this or not i don't think we have disclosed it and and we are we're typically not giving the relationship between different markets Okay, that's all for me. Thank you.

Next question is from George Tegalon of Bjarke from ABG Sandal Collier. Please go ahead, George.

Hi, this is George from ABG. I have a couple of questions as well. So first, I'm wondering if you can give any insight to where the German patients adding roughly 20% year-over-year growth are coming from. And then secondly, regarding Oxy-ISA, when do you expect to launch in France, Spain and Italy? Thank you.

So when the first question you had was that regarding Buvidal?

Yeah, regarding what kind of German patients are getting or adding at the moment. Okay, I'll leave it to Richard.

I'll leave it to Richard. So 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 and in the community setting and that's it's coming from there so it's a mix I can't say there's one specific segment where other prisons is key but also so is the community setting.

And when it comes to the other question I mean we are starting in the wave one countries in parallel we are you know doing our market access work for the rest of europe and we will kind of announce as you have seen for biblical we have added countries now for we are in our seventh year and and we are still adding new countries in the markets but i wouldn't say that we are expecting to see france on board for instance until at the earliest next year great thank you thank you so much

Next question from Dan Acciuti from Pareto Securities. Please go ahead, Dan.

Hello. Just two more questions from my end. And one would be if you could share any comments with regards to your communication with LELEs that frequent on a monthly basis, for instance. And are they happy with the data? And 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? Can you reallocate that to other geographies if the UK would take more time? Thank you.

Yeah, so on the first question, I have to say that we, 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. So I think the information that is available now is what we can say about the current state of that collaboration. So on the second question, Anders.

Yeah, we can definitely sell the product continuously. So there's no question about that. So that's a very simple reply to that one.

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

Okay, perfect. Thank you.

The next question from Mattias Hengblom from Handelsbanken. Please go ahead, Mattias.

so much for taking my questions I have two so I'm coming back to this hundred thousand patient target so with the net positions of thirty thousand required to get there should we think of net patient wins as linear from here or should we think of them rather as back and loaded as more and more reimbursement hurdles are removed and 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 Bovidalen, 1.5 billion krona from pipeline. When I look at the interim consensus, it's largely at the 4.5 billion krona level, but the composition is different, 2.6 from Bovidalen, 1.9 from pipeline. So 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 CDMOs inspections as well as slower accrual events in the Sorrento trial. Thanks so much.

I'll take the first one on the pickup of patients. I mean, I don't think there's a clear answer on this one because it depends on when we achieve the funding. So yes, obviously it's more likely to come later as we get there, but we're in quite advanced discussions with some areas that we could move more quickly. So that would depend on some changes that we need to make in discussions with the stakeholders involved in this. So I don't think there'd be a clear answer on that.

I mean, 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. So there is, I mean, it's a mix there and it's not easy to give you. So far, we have been quite linear, as was shown in the figure here earlier. So we need to pick up some more patience to reach the 100,000 by the end of 2027 for sure. And the 4.5 billion, yes, I mean the mix obviously in five years things happen in terms of the different programs advancing. We have maintaining our ambition. You see basically how Byggrad is evolving and the contribution can be closely to where we were expecting it. We have uncertainty to how quickly the Riksaldi sales will continue growing. We are hopeful there, of course. So those will be two major contributions. The delay in Sorrento in the event rate may have an impact. In that case, to reach the goal, we will need to add additional revenues. On top of this, we also have a number of milestones that can come in in 2027. But I would say... Overall, we are not that far from the distribution that we mentioned in the 2022 CMD. But obviously we weren't exact and will not be exact. That's helpful.

Thanks so much. Next question from Erik Hultgaard from D&B Carnegie. Please go ahead Erik.

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 Oxy-ISA 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 somatolin or mainly sandostatin switches? Thank you.

Okay, I'll leave the first question to Anders.

so it came out from the volatility in the UK market so 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 and also because we have the upcoming loans of OXISA but then also when I look to the future accounting principles how you report especially rfs 15 and 18 then this model is much more suited for us so that was why we we did it and then it made sense to do it by the end of the year so it was very clear and on the oxyisa patients i would say that

All of them were switches from both treatments. We should, of course, be aware that there was only basically one and a half month or so recruitment time since the launch and availability of product in the market. And I think we saw a good pickup in that time period. And I think we'll see continued. I mean, the positive note is that most patients in Germany are on treatment. So, I mean, there are many fewer coming in new patients per month or per time period. So this is a very good signal for us. And it seems to be progressing nicely also into the early part of this year. So we are happy with that, but I think you should assume that most of our patients will come from switches of current treatment.

All right, then just to 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 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 didn't have to do or hadn't had to be exposed to getting New allowances for prescriptions. I don't think 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.

Thank you so much.

Gonzalo has a follow-up from Danske Bank.

Yes. Hi. Thank you. It's one on PLD. Could we assume that you guys will start a phase three this year if you have the end of phase two meeting now in March, if I heard correctly? And if so, is this baked into guidance? Thank you.

Yeah, so the important thing here is we will, of course, we are seeking the agency's advice on the study design of the PLD study. And should we get perfect alignment with them in the first meeting, then there is definitely a probability. But 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 result expectations.

Thank you. Christopher SCB also has a follow-up. Please go ahead, Christopher.

Yes, thank you for taking my follow-up. 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? And if there would be a rollover, how would that impact 2026's funding allocation? Thank you for the first one.

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

That's helpful. And then the second question is on the runway remaining in the AMIA region. And I guess within that also particularly Australia, how much more penetrated can long-acting injectables get in those markets?

Yeah, I think there's still a regional opportunity. There's still reasonable numbers of patients on sublingual that would many of whom will benefit from moving to a long acting. And 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. And we're seeing Firstly, demand growing and also the numbers of patients moving away. In Australia, for example, we're seeing methadone gradually declined, but we have 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.

Yeah, I think we have said earlier that we believe that we could ideally 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.

The next question is from Sian Hama from Jefferies. Please go ahead, Sian.

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

I think, you know, what we said is we are believing that overall we continue to grow in a steady fashion. And the remainder of what is baked in, you know, should be essentially brick-sided growth, according to our projections.

OK, understood. Thank you. And then my next question, please, is With the end of phase two conversation that you have with FDA in March for the PLD indication, where does that place potential phase three start and therefore the timing of the costs for that study?

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

That makes sense. My final question, please. Could you clarify the England funding situation? So there's funding that was meant to go from last year that was meant to arise that never hit the clinics. When is that expected? And then you said, is there another round of funding that could come or be communicated by April that was then hit in 2H? Could you just clarify the timing of the funding?

Yeah, so 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 of which for public health, of which a large proportion is allocated specifically to drug and alcohol addiction. So we anticipate that coming in. We anticipate last year as well, and it didn't reach it. So we have to wait and see. But 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 26 at some time.

All right.

Thanks so much. That's all. The last one is from Romy, a follow-up from Van Lanshot Kempen. Please go ahead, Romy.

Hi, thanks. Just one follow up from me. Can you please provide some more color on your M&A and BD priorities for 2026? And is there any specific criteria or areas that you are looking at? Thank you.

Yeah, 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 or the more global setting so that's the main target for us so that would be in endocrinology rare oncology potentially other rare disease indications and and cns And 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. But I would say, I mean, our core focus is on late stage opportunities, as mentioned earlier.

Great, thank you so much.

No more questions, so I hand the word back to you, Fredrik.

So thank you, everybody. I think and hope you see that we have a solid foundation for the year to come. And I look forward to updating you all together with the team on our Q1 presentation and meet you in between. So thank you very much for listening and asking very insightful questions. Thank you.