Camurus Aktie

[Audio Gap] In-market sales were up 19% versus the same period last year and 6% quarter-on-quarter, which reflects strong underlying demand.

Growth was broad-based across geographies, including the Nordics, Germany, Spain and France, and U.K. saw improving sales as new NHS funding starts to become available. Australia was steady with prescribing capacity in parts of the market, a limiting factor that we're addressing with clinics and providers.

Ubeda remains the clear leader there with over 80% of the LA IB segment and an overall market share of patients above 30%. In Australia, at the end of the quarter, it was announced that the other long-acting buprenorphine product is being withdrawn from the market by the end of 2026.

The product has a minority share of the long-acting injectable buprenorphine segment and our priority in this regard will be to ensure continuity of care for patients working with clinics as we've done similar transitions in Sweden, Finland and Germany.

We ended the quarter with an estimated 77,000 patients in treatment, up a net 4,000 and we're on track towards the 100,000 patient ambition by the end of 2027.

[Audio Gap]

Clearly, the ACRINova-3 program is completed, and it's being communicated at various medical conferences and elsewhere. [Audio Gap] Oxia is approved in the U.K. and EU and the European launch is underway.

In the U.S., the FDA issued a complete response letter for Atlas in June. Importantly, this relates to observations during a previous GMP manufacturing inspection at a third-party site and not to the efficacy or safety or otherwise for CAM2029.

Those observations have now been addressed and new PDUFA target action date is the next important regulatory milestone for the program.

Our view of the clinical profile and commercial opportunity for CAM2029 remains unchanged. Our largest near-term opportunity, though is gastroenteropancreatic neuroendocrine tumors, a substantial and growing market with considerable unmet medical needs.

Sorento is the largest randomized study of somatostatin receptor ligand in Gap net to date and is our most important pipeline catalysts this year. The study has been fully enrolled since the end of 2023.

And based on current event accrual, we expect to reach the target of 194 progression-free survival events in the fourth quarter followed by the readout of primary results.

A positive outcome for CAM2029 that would support the compound as a new first-line treatment option opening a very meaningful new growth avenue for cameras. Finally, in polycystic liver disease, the positive Positano Phase II results were presented and recognized at this year EASL conference in Barcelona, a leading hepatology event.

We hold orphan drug designations in the U.S. and EU for PLD and ADPKD and have completed the FDA end of Phase II meeting this year, and the extension study is currently ongoing, which together with the feedback will form the basis for the decision around the continued Phase III program.

Beyond CAM2029, our earlier-stage pipeline gives us additional exposure to large therapeutic areas while allowing us to leverage the same long-acting delivery experience that underpins our commercial portfolio.

CAM2056 is our once-monthly semaglutide depot based on the fluid crystal technology. During the quarter, we completed a Type B meeting with the FDA and the regulatory submission package for the Phase IIb clinical trial has been prepared.

The study remains on track to start in the second half of the year, building on the positive Phase Ib data reported in November. Product design work is also ongoing in parallel, including the validation of auto-injector pen to support simple once-monthly dosing.

We see a meaningful opportunity for once monthly incretin therapies overall, particularly given the adherence challenge seen for current weekly and daily treatments. Our collaboration with Eli Lilly is progressing to plan. During the quarter, Lilly exercised its option to include amylin agonists and expanding the scope of the partnerships beyond the dual and triple incretin agonist that we had already started.

We view this as a further external validation of the fluid costal technology and its potential in the long-acting metabolic medicine space. With Gubra, we have selected the lead compound for our long-acting parathyroid hormone and analog program and are advancing into further development.

Taken together, these programs provide several independent opportunities to create value across large and underserved therapeutic areas, supported by our own development capabilities and 2 well-resourced partners.

Let me close with some brief quarterly summary and priorities ahead. Our strategy rests on four clear priorities: first, commercial execution, extending our leadership in the opioid dependence area with Burra and Brixadi and advancing the Oxia launch in Europe strengthening the revenues and broadening the CAM2029 commercial efforts.

Second, advancing our pipeline with multiple near-term catalysts, with a rental readout in GAAP net the start of the CAM2056 Phase IIb and the U.S. resubmission pathway for Okla, alongside progress in the broader portfolio.

Third, partnerships and business development. We are progressing our collaborations with Lilly and Gubra and we remain active in evaluating opportunities that can broaden our pipeline and add long-term value for the company.

And fourth, financial strength, we have been sustainably profitable since 2022 and ended the quarter with SEK 4.1 billion in net cash giving us the means to invest behind our launches, pipeline, business development opportunities while maintaining strategic flexibility.

The second quarter showed our model is working with record product sales, strong profitability, disciplined investment and a robust balance sheet. We now enter a catalyst rich second half with clear priorities, commercial execution, pipeline advancement and selective capital deployment.

With strong momentum across the business, we are well positioned to continue creating value for patients and, of course, also for shareholders. Ana, with that said, we are ready for the first question.

Thanks, Kenric. The first question is from Gonzalo Atia from Danske Bank.

Congrats on good quarter. And my first question is on Buvidal. You mentioned in the report strong performance in Nordics, Germany, in France. Just to get some clarity here, is the growth this quarter in any part driven by stocking in any of these regions that we should account for future estimates. And how should we look at these regions forward? And I'll continue with another question after.

Okay. I'll leave it to Richard to respond.

No, it was underlying demand. The growth was broad, as we said, across the countries. You mentioned Nordics, Germany, Spain and France and all considered alongside U.K. growing as well. There were no one-off effects in the quarter.

Great. One question on Q3. I mean Q3 tends to not be the best quarter for Buvidal in Europe due to the holiday season. How much are you guys expecting this to affect Q3 is the second half of this year, especially back end loaded in your estimate? Or how should we see this?

I think it's difficult to give any predictions about Q3. We don't expect to see I mean, generally speaking, we have seen in the past years, we have seen relatively okay Q3 developments. And I think it's too early for us to give any other indications.

Okay. Perfect. And 1 last question. It's on the CRL in the U.S. Could you clarify what is the status of the contract manufacturer you are starting in the U.S. right now. And I know you cannot give much details right now, but what would be the reasons to remain in the contra factor you have in Europe on the back of the 2 CRLs, you have got and not moving straight to the U.S. line with your other partners there?

Well, I think that, to be frank, our current manufacturer has been capable and able to deliver. Unfortunately, we have this CRL, so that's something we are accounting for. But strategically, we have decided to build out and make sure that we are not sitting with 1 single manufacturing unit, so we need to have broader capabilities and that's the reason. But I don't think we can say anything further on that.

If you're looking at the commercial supply performance and also the regulatory discussions with other authorities, we have not seen any issues with current supply.

The next question is from Roni Kolomela.

This is Sai on for Romi. So I have 2 questions. You noted that the outstanding FDA comments have been addressed and that a further regulatory update is soon for the OkrayU.S. -- approval. Can you maybe help us understand what still needs to happen before this resubmission? And if you still think this is going to be a 2026 resubmission or if it's more likely for 2027?

So from our standpoint, remediations have been completed, and that means remediations in relation to the CRL we received on the tenth of June this year.

As you know, these were, as we say, third-party related. On the other hand, there was a small point also on this oxygen scavenger and that has been also addressed so we are hopeful that we will have a resubmission confirmation as soon as possible that we are not giving any further details at this moment.

But I think 2026 is clearly an opportunity.

Okay. And my second question is, are you able to outline the differences between the 2 CRLs that you received?

Not really because, I mean, essentially, they were very similar in the sense that there had not been an inspection and therefore, you can say that the earlier remained. So that's the situation. We believe the manufacturer has been in contact with the agency, and we believe that this communication and also provided inspection readiness declaration.

So we are expecting the agency and most likely, we'll do an inspection at some point but it's obviously FDA on the table of FDA and not us.

Yes. Next question is from Shan Ham from Jefferies.

I've got 3, if I may. Just to continue on the Orkla CRL. Has the manufacturer communicated that they expect an inspection to definitely happen this time around? Or is that still uncertain?

I would say that considering circumstances, it's highly likely that there will be an inspection of the manufacturer.

Understood. And then my second question, please. Is that a ballpark figure you could provide us with on the size of the Brabant sales force in the U.S.? And what kind of commercial investments are being made there?

Well, I think not aside from what we have said earlier. I can't say that they have made a significant addition to both its commercial customer-facing sales force and medical in the last quarter and on a size wise, they are on par with -- currently on par with with other companies in the space.

Understood. And then my final question, if I may. At what point during the year, will you get sort of further visibility into supply for Buvidal to the U.K. should we be expecting an acceleration in the second half of this year based on your current visibility?

I think, as Richard said, I mean, I think right now, we have a process where we have a lot of contributors behind our growth, and we are expecting the U.K. to develop in a positive direction.

I mean it's difficult to give you any direct indications of when is -- but we are already seeing some positive trends. So overall, we think that, that will be helpful.

And obviously, there are also other discussions and processes ongoing. So we will see how it evolves but so far, it's looking positive.

And I think the most important thing is that we see stable growth across European markets at this point, as Richard already alluded to.

[indiscernible] compared to securities. Please go ahead, Philip.

I've got a couple of questions on Australia here where you seem to have had a bit of a cautious tone in the report. So firstly, just on the competitor here that we're drawing towards the end of this year. So we now have 80% market share approximately. So do you anticipate capturing those last 20% sale quickly during 2027? Or how should we think about the dynamics there? Or do you think some patients will switch back to orals, for instance?

Well, I think -- I mean it's important with continue to our care and we are doing what we can on the medical side to make sure that we assist in any necessary transfers.

And what we have seen in previous transfers in the Nordics, for instance, it's been largely most patients have been transferring over to Pivotal and it's gone according to our reports very swiftly.

So if we see the same trend that we have seen in the European countries, it should be a vast majority, and it's happened in reasonably short notice.

So I would say that, yes, shortly after the supplies out in end of '26, it should be a transition secured.

Okay. Okay. Very good. And then just on the overall long-acting market in Australia as well. So I think you stated you have 31% share of all patients now under in Australia. And you previously talked about a possibility of reaching about 50%. So you still really confident about that? And can you talk a little bit what specifically needs to change for the market to expand to that level?

I mean I can start and leave it over to Richard. I think that, I mean, the 50% is what we have seen is somewhere -- I mean that's scenario in the future, so to speak.

But we see definitely we already have over 30% and adding the patients is about 36% of patients now currently standing on long-acting injectables.

So it's been a very successful entry into the market, Richard, you were?

No. I mean Australia is still growing. I mean, even without the opportunity with the other long-acting we're being withdrawn, so it's still growing. There are some capacity issues in the market, it's about patients accessing treatment per se, not thing there, but we're working very closely with the clinics. We're doing a lot of programs, for example, pharmacy injection which releases capacity in the clinics because patients then can go to the pharmacy and have their injection and move on.

And that's been a successful program in a number of states, and we're rolling that out further as well now.

And maybe I should add to that, so that in Australia, there's still about 40% of patients that are being treated with methadone. And we're seeing an increase in flux of patients from methadone over to buprenorphine. So that is another positive source of potential growth and patients in the future.

Okay. And perhaps lastly, just related to that, you stated year-to-date growth in Australia was 6%. So is it reasonable to expect that staying in the single digits due to this capacity constraints in the near term or do you see like you could penetrate the market and accelerate the growth back to double digits, for instance?

I think we'll update on that in Q3.

Okay. That's all for me.

Next question is from SEB.

Christy. My first 1 is on your SG&A. It was up sharply as was expected, I guess, ahead of presumptive U.S. launch of Oak lays, but that's, of course, now been delayed. And at the same time, you've beefed up your Australian sales force, and obviously, you're busy rolling out AXIS in the EU. So how should we model the cadence of SG&A over the remainder of '26 and into '27 and consensus is modeling a 30% year-on-year increase in '27 to 30% of sales.

Are you comfortable with consensus SG&A expectations? That's my first question.

Yes. So Anders here. I would -- so what we saw in the first half, just to see it from our side is that we prepared for the launch, of course, and then we had an increase also across the globe. So half of the increase in SG&A came from the U.S. and half from the rest of the world.

So it's a balance. Of course, there were some upfront investments in the U.S., and that, of course, depends on when we will have potential approval when we will hire the sales force. But I think it's fine the assumptions you have. One comment I could make, especially on the R&D is on the R&D cost for the Q2.

There were some capitalization of some products because now we have launched in acromegaly. So that has offset some of the costs we will normally take and capitalize it. There's around EUR 20 million we've taken in the Q2 numbers for the R&D.

Okay. And then so you've said Indivior, of course, has about 20% share and obviously plan to be out of Australia. So should we just assume a 25% ramp for you between now and year-end? Or should it be from year-end? Just a clarification there. And then how much of your ex Europe sales of Buvidal are actually from Australia, if you wouldn't mind sharing that?

On the first note, I think it's difficult to make any assumptions at this point because we have not -- this is a recent news and we have not. But obviously, there is somewhere around 4,000 to 5,000 patients that are currently standing on the other long-acting injectable product and they will reasonably be transferred across the time, over the time until the product is -- so with fully withdrawn in the market.

So I think based on that, I think it's anybody's guess, but I think that's the fundamentals here. Unless something surprising happens that I cannot but I have difficulty being more precise than that. And Richard, the follow-up question then.

Can you remind me the question was?

Ex Europe sales, what proportion is Australia?

I think maybe I can say, we're not really comfortable going in, taking that right now because it varies very much from quarter-to-quarter.

Australia is a very, very important market for us, as you can see.

If I could just ask 1 more question. It would be on the Phase IIb SEMA trial. Can you tell us now about the design and particularly the size, duration and dose levels, please?

We will do -- give an update as soon as we have that approved and on track and that should probably come relatively shortly. So we will update on this -- thank you. It will be a placebo-controlled trial this time.

Next question is from Josh ideal from ABG Sundal Collier.

Hello. This is Stuart from ABG. I have, please. So first, regarding to rental. Can you clarify if also the announcement of the initial data can be expected in Q4, and then secondly, I'm wondering if you've seen any recent net price changes for Godda or Brigade.

So when it comes to the first question on Sorento, I think timing. Yes. Yes. No, no timing of results vis-a-vis timing of reaching the events. So obviously, it will depend on when we reach the target number of events so if that comes earlier in the quarter, we might have delivery of results in the quarter.

If it comes later, there may be a gap of course, between reaching the number of events and reading out full data.

Yes, on the pricing of Bonial, they're pretty stable. There is, of course, a country mix comes into play depending on the volumes in each country. But generally, in the market, the prices are very stable.

There are no more questions at this time. So I hand the word back to you for closing comments.

Okay. Thank you, everyone, for attending the call. It was pleasant as always, and wishing you all a continued nice summer and speak next time at Q3 or earlier.

Welcome to Camurus' Q1 Report 2026. [Operator Instructions]

Now I will hand the conference over to CEO, Fredrik Tiberg. Please go ahead.

Thank you so much, Rein Piir. Good day, everyone, and welcome to our first earnings call in 2026. Please note first our forward-looking statements. Here is the agenda for today. I'll start with the highlights; Anders will cover the financials; Richard, the commercial update; and I'll return with a pipeline update and key takeaways before moving to Q&A.

Starting with a few words on the quarter. As we stated in the report released earlier today, Q1 was on track with our full year guidance. Revenues recovered following the U.K. distribution model change and we made continued progress across our commercial programs and development pipeline. Financially, total revenues were SEK 533 million, a 15% increase versus previous quarter, but a 5% decline year-on-year driven by FX and channel phasing in 2025. We maintained strong profitability with a 32% operating margin and ended the quarter with SEK 3.9 billion in cash. Importantly, we look forward to a robust growth trajectory for the rest of 2026.

Commercially, reported product sales were down 12% year-on-year or 6% at constant exchange rate. However, underlying in-market growth was significant. Buvidal grew 17% and Oczyesa delivered its first full commercial quarter with SEK 4 million in net sales in Germany alone. Brixadi royalties increased 44% or 59% at constant exchange rate. And on the pipeline side, and this is what is going to be particularly eventful in the coming quarters, the FDA accepted the Oclaiz NDA in the U.S. with an anticipated decision date of 10th of June this year and SORENTO continued to progress towards the primary readout in GEP-NET. I'll come back to both of these programs later on in the call.

With that said, Anders, over to you and financials.

Thank you, Fredrik. Overall, the first financial quarter results met our expectations. Moving to the next slide. You can see the main components of the profit and loss. Camurus reported quarterly revenue of SEK 533 million down from SEK 558 million, year-on-year 5% decrease. However, at constant exchange rate, revenues grew by 3%. The overall decline is primarily due to the unfavorable currency effect and channel phasing. On a sequential basis, revenue increased by 15% from Q4 driven by a onetime impact of SEK 93 million resulting from the change in the U.K. distribution model in the previous quarter.

Total OpEx for the quarter amounted to SEK 328 million, a 13% increase year-on-year primarily driven by the continued investments in commercialization and R&D. Marketing and distribution costs increased to SEK 130 million fueled by the expansion of Buvidal IP as well as the company's entry to the U.S. market. Administrative expenses reached SEK 47 million. R&D spending was SEK 138 million, year-over-year an increase of SEK 7 million. For clarity, the anticipated significant increase in R&D and U.S. launch spend will primarily occur in the second half of this year.

The operating result for the quarter was SEK 168 million, down 30% or 15% at constant exchange rate compared to the same period last year. The operating margin was 32% and earnings per share before dilution was SEK 2.42. Moving to the next slide showing the cash flow. The quarter cash flow shows SEK 150 million increase in the cash position compared to the end of '25 primarily driven by a solid operating cash flow of SEK 162 million. The change in working capital had a modest negative impact of SEK 9 million primarily due to the reduced accounts payable and increased trade receivables.

Cash flow from investing activities was negative SEK 39 million primarily due to the establishment of a second manufacturer for Oclaiz in the U.S. Financing activities added SEK 21 million mainly from the exercise of the employee stock options. This resulted in a very strong cash position of SEK 3.876 billion at the end of Q1, a 35% increase compared to the same time last year. This solid financial position gives us the flexibility to continue investing in our pipeline, expand our global commercial operation and seize strategic opportunities as they arise, all while creating sustainable value for our shareholders.

With that, I'll hand over to Richard.

Thank you, Anders. So starting with Buvidal. The quarter was in line with our guidance assumptions. Reported sales of SEK 422 million were down 13% year-on-year or 7% on a constant exchange rate basis, which reflects the U.K. channel phasing we discussed. The more meaningful metric is in market sales, which grew 17% year-on-year so underlying demand is strong. Nordics, Germany, France and Spain saw robust growth and Portugal saw rapid initial uptake following the release of funding to the treating clinics. Overall, health care professional and patient response in Portugal has been very positive as we've seen in other markets.

In Australia, we saw the usual seasonal softness from the summer period. Sales there typically build in Q4 ahead of the vacations before normalizing in Q1. The U.K. remains a focus area. Funding restraints from the prior year carried into Q1, but importantly, a new 3-year budget was announced for the NHS financial year starting the 1st of April. We expect this to lead to meaningfully improved patient access going forward. During the quarter, some notable policy support for Buvidal was published in both England and Wales with calls for more access and funding for long-acting buprenorphine.

In Germany, the Federal Audit Office who carries significant weight politically has recommended shifting physician remuneration for opioid dependence treatment away from per dispensing payments towards consultation and coordination of services and has called on the Ministry of Health to update the reimbursement framework accordingly. If and when implemented, this structural change is expected to remove a key barrier to patient access to innovative treatments for opioid dependence. And at the end of the quarter, approximately 73,000 patients were estimated to be in treatment with Buvidal and we continue working towards our 2027 ambition of 100,000 patients.

Now turning to the U.S. Brixadi royalties in Q1 were SEK 106 million, up 44% year-on-year and 59% at constant exchange rates. The quarter did see some seasonal softness from annual prior authorization renewals and payer mix dynamics, both of which we expect to normalize as the year progresses. And the underlying trajectory remains very strong. Brixadi's equivalent unit share reached approximately 32% of the U.S. long-acting injectable buprenorphine segment according to external audit data, which is up from 26% a year ago. And that segment itself is growing more than 30% year-on-year. So we're gaining share in an expanding market.

Braeburn continued to invest materially in the franchise, including expanded patient-facing commercial activities and we remain confident in the strong trajectory through 2026. Now moving across to the launch of Oczyesa in Germany where we had a good first full quarter. Sales reached SEK 4.2 million with approximately 50 patients in treatment representing about 2.5% share after just 1 quarter. The product profile is resonating with both patients and physicians and whilst we anticipate the rate of uptake to normalize going forward due to the cadence of patients visiting clinics, we continue to expect penetration towards a double-digit share in Germany by year-end.

Beyond Germany, launch preparations are advancing. In the U.K., we secured listing on the NHS National Framework agreement and have submitted 13 formulary applications and pricing approvals are in place in Norway and Sweden. And sales and medical teams are in place across our Wave 1 markets. The opportunity in initial launch market is an estimated 3,000 to 5,000 patients on current standard of care somatostatin analogs. Our market research indicates a 30% to 60% willingness to switch.

Now turning to Oclaiz in the U.S. With the FDA PDUFA action date less than a month from today, our U.S. commercial team organization is launch ready. The core team has spent the last year executing a comprehensive prelaunch plan across every work stream. With these foundations in place, we are well positioned for an anticipated U.S. launch of Oclaiz in Q3 2026.

So with this, I'll hand back to Fredrik for the R&D update.

Thank you. Moving over to a brief pipeline update. So starting with CAM2029 where we have 3 programs in parallel. In acromegaly, as Richard said, the PDUFA date is set and we are ready to launch once and if of course we receive approval. We had a strong presence at the ongoing European Congress of Endocrinology in Prague. We had a rapid fire oral presentation, several posters and a symposium on new acromegaly treatments that attracted around 500 participants. The meeting is finishing this week.

So it's been a very good showcase for our ACROINNOVA data that continues to build and we look forward to an equally productive meeting at ENDO in Chicago later in this month. In GEP-NET, SORENTO is progressing according to plan. Event accrual is tracking towards the target of 194 progression-free survival events expected in the second half and this will be then followed by the readout of primary Phase III data. And as you know, with 332 patients across 12 countries, this is the largest randomized sustained release somatostatin analog study in this indication to date.

And a positive superiority outcome would be a major milestone for Camurus and of course also for patients. In polycystic liver disease, we completed an end of Phase II meeting with the FDA and the first patients have now finished the 2.5-year POSITANO extension study. Here the next steps will be informed by the FDA guidance and the extension data that is coming successfully here. And we will also in this area present new POSITANO results at EASL in Barcelona later this month with an oral presentation at the opening day.

Moving over to the next program of interest of course CAM2056. Here we have continued to work on the preparations for the Phase IIb study, which is advancing and is going to initiate in the second half of this year following a Type B interaction with the FDA that we had earlier in the quarter. In parallel, we are developing the final product formats including the auto-injector pen for Phase III and commercialization. Our partnership programs have also advanced during the quarter with Eli Lilly R&D activities on the long-acting incretins using our FluidCrystal technology are progressing to plan.

And with Gubra, we are jointly developing a long-acting PTH analog for hypoparathyroidism with a candidate selection planned for mid this year. And in addition, we have other new exciting programs advancing through early development. So let me now turn to our priorities going forward. As you heard, the quarter is on track with full year guidance reaffirmed. Underlying commercial momentum is strong. Buvidal in-market growth of 17%, Brixadi up at constant rate is 59% over the year and a good first quarter for Oczyesa in Germany.

From here, we expect performance to build through the year supported by improved market access, the U.K. funding framework now in effect, continued Brixadi momentum and the continued European rollout of Oczyesa. Looking ahead, several potentially significant milestones are of course in front of us, including the Oclaiz FDA action date and the SORENTO completion and primary results and together also with the start of the CAM2056 Phase IIb study and of course also our partnerships. So we are all in all confident in delivering on our 2026 objectives.

And with that, I'll just let the floor open for questions. Please take over, Rein Piir.

The first question is from Gonzalo Artiach from Danske Bank.

The first one, I think that it would be great if you could provide some color on the U.K. situation. In your report you're mentioning that funding now has been announced, but when is this funding? In detail I mean if you could give us some color here expected to arrive to clinics? Is it already in place since April 1? And have you started seeing some kind of momentum or positive signals in the U.K. here? And I was wondering if you could also give us some color on your guidance range and I don't know if you could provide some granularity on the top line range that you provide. I mean how much is the U.K. funding healing clinics in the right time baked into this range?

Richard, do you want to start?

Yes, sure. So on the U.K., obviously the multiyear funding framework that's been announced is a meaningful step forward and it provides I think the commissioners or the commissioning treatment a certainty over 3 years and removes one of those key barriers that was preventing prescribing because some of the clinics didn't know whether they have continued funding, they now have that. We expect the effect to build gradually. It takes time for the budget allocations coming through, but we expect to see it during Q2 and then obviously in the second half of the year.

But the meaningful impact will be in the second half of the year. I mean the grant itself is quite substantial. It's a total public health grant of something like GBP 13.4 billion. Obviously that's not just for substance misuse and other public health grants, but substance misuse is part of that program and that's a meaningful increase than they had before. So really the summary is it's 3 years, which is important and it's an increase that happen before. So we're positive that's going to make an impact.

And maybe we should add that we are also working on other complementary activities. So this is a very important foundation, but we're also looking at other options going forward. When it comes to the guidance range, Anders, do you want to take that question?

Maybe being too specific going into the U.K. numbers, but I can confirm that the Q1 result is aligned with our internal projections also on the country level overall. So yes, but I can't go into specifics for the U.K.

Okay. That's clear. One question if I have the time that's on Buvidal. In your report you say that you're expecting completion of events needed in the SORENTO study to close in H2. From what you know now, are you guys expecting more of a [indiscernible] push potentially read out to Q1 next year or you're expecting readout also this year?

We haven't changed -- I assume you didn't mean Buvidal, but you mean CAM2029. So I mean we maintain our expectations to have the readout in the second half or actually to have the events occurring in the second half I should say. And the events, I mean there are 2 pathways for that. So we are expecting a large update in the end of May. So I will give you further clarity into more detailed planning of times once we have that. But as you know, it is event accrual is progressing aligned with our expectations, but you need to have the last event to be able to close the trial. So there is always going to be some uncertainty in these numbers coming in.

The next question is from Romy O'Connor from Kempen.

I have 2 quick questions. The first one, how do you expect growth to look like for patients on Buvidal treatment considering your target of 100,000 patients by year-end? So if I'm looking at an additional 3,000 patients on average quarter-over-quarter, how do you expect to reach your target? Second question, you also mentioned that collaborations with Lilly and Gubra progressed with development candidate selection for Gubra planned mid this year. Are you able to provide some additional color on this or is there any insights on clinical development timelines?

Yes. Do you want to throw it out, Richard?

Yes, I can start with the path to 100,000. I mean yes, we set our ambition there for the end of 2027 and as you say, it needs a 3,000 net patient gain. Obviously going forward, this requires continued progress in the market access programs that we've ongoing. Obviously the U.K. was a good step in the right direction and we see that hopefully solving that problem,. We've also got expanding geographies as well as new markets are picking up well and we're going to be launching a couple of new markets relatively soon as well. So I think overall we can still achieve that with the tracking that we're doing at the moment.

Yes. And Romy, could you please repeat the second question?

Yes. It was just any additional insights on clinical development timelines with Lilly and Gubra.

Yes. Unfortunately, we have to be -- we don't provide any guidelines updates on the Lilly collaboration at this point. However, with Gubra, we are making good advances also in the preclinical side and it's difficult to give direct estimates about when we can start clinical phase studies, but we are working effectively together with them and I think potentially next year. That's how far I can go I think.

The next question from Christopher Uhde from SEB.

Christopher Uhde, SEB. I guess I'd start off on perhaps the U.S. side of things. Indivior made some interesting comments on its call noting sort of success with their rapid initiation where they're saying they're the only ones who have that and also the accelerated first dose. They talked a lot about their DTC and then "enhanced service agreements" with key specialty pharmacies and expecting to double volume growth basically year-over-year. What are your reflections on the relative importance of these various initiatives in sort of, let's say, limiting Brixadi uptake after what was initially an extremely fast launch that since kind of moderated a little bit? Obviously you're still taking share as you pointed out. But to what extent is Braeburn pursuing any of these kinds of efforts itself as well? That's my first question, please.

Yes. First of all, I think it's important to say that we are looking. Our primary expansion potential or Braeburn's primary expansion potential is of course in the 90% of patients that are currently treated with sublingual therapy. But nonetheless, that's still a very important question that you have here. In terms of the rapid initiation, we have of course had that from the beginning in terms of our weekly to monthly switch and the possibility of starting Brixadi directly along with many other features that are still making Brixadi into a very differentiated treatment.

I think what I've seen from the Indivior regimen, of course they are giving 2 monthly doses within the first week, which is of course going to be positive at least from a number of units perspective used in the treatment at the start of treatment. So definitely that will grow at least the initial part of the treatment and I think it's useful for patients to have access to a new initiation regimen. I don't think -- I mean we're seeing continued good uptake and so we are not -- at least on our side, we feel quite comfortable with the situation we have and the differentiation that Brixadi has. Do you have anything else?

Yes, if you wouldn't mind, I was wondering about -- so there was an article in the San Francisco Chronicle a little recently discussing Brixadi and SUBLOCADE and the importance of initiating at the correct dose and talking about patients who refused a second dose after experiencing withdrawal I guess triggered by a too high dose of Brixadi. Would you please talk a little bit about the level of adherence you see? How it compares to the competition to the best of what you're able to see? And can you help us quantify how your broad range of doses contributes to this and particularly in view of the fact that your competitors' low dose is at the high end of what you offer?

I think this is a very intricate discussion and I'm happy to take it, but I think it's a little bit too complex for this setting. I mean it is true that very high initiation concentrations do have an impact in terms of the side effects that can be seen with buprenorphine if that's what you're referring to. Having had this discussion in the European market, we see for instance now when patients are switched over to Brixadi or Buvidal in Europe, we see no changes whatsoever and we see very high efficacy and very high retention. So I cannot speak to a specific report from 1 physician in San Francisco. It's difficult for me. But please share the information and I can follow up on that separately.

I appreciate that. If I could throw in 1 last question just on Buvidal then. So obviously the U.K. has apparently resolved. But how will the new framework really work I mean structurally? Does it potentially cap your growth then in the U.K. over time let's say and if there is a cap, is it so high that it doesn't matter in practical terms? And do you -- obviously it was a bit of a slow start then in the year from the U.K., but do you expect a sort of full or partial recovery then in revenue, let's say, perhaps from the perspective of consensus expectations?

Yes. I mean right now in the end market, we're growing 17% and the reported sales are impacted by the change in distribution models that we've had in the U.K. to underline that. I mean the new funding we do anticipate improving access to patients. I mean typically, numbers talked about in the U.K. are somewhere between 20%, 25% of patients should have access to long-acting buprenorphine at least in the first wave and that's what they'll be heading to.

The new money helps that. The certainty around the 3-year funding arrangement that goes up over 3 years, it also supports that as well. And I think it's given confidence both to commissioners to commission now because they know it can be a longer-term process and also for providers of treatment to start initiating patients without the fear that the money might not be available next year. So it's given that certainty to the market.

And I guess a clarification on the -- what I meant is should we see it as phasing of what we were already thinking of I mean growing over 20% in Europe or should we see it as perhaps moderating that slightly? That's all for me.

No. I mean it's obvious. It takes time for those funding to come through to the clinics of course just because of the bureaucracy around it, but we expect to see some signals in Q2 and then particularly in the second half.

Next question from Shan Hama from Jefferies.

I've got 3, please, if I may, and I'll take them one at a time. So firstly, if you were to sort of order varying headwinds in terms of the level of impact from greatest to least for Buvidal, how would you order Australia seasonality, U.K. distribution model change, FX? How would you order those 3 in terms of level of impact?

Yes. I think we should limit that question to the headwinds in the quarter because I think we have quite a good outlook. But Richard, maybe you take that.

I'm not sure what the question is really. I mean Australia will pick up. The underlying growth is still there so that's just seasonality that we know so we see that be improved in Q2. I think the underlying growth in the U.K. will be reflected in Q2 rather than being impacted by the change in distribution model that we saw in Q1. And then FX you saw I think from what I said that of the revenue change, I think approximately half of it was down to FX and half of it was down to the distribution model change.

Okay. That's clear. And then my second question, please. I know sort of you mentioned Braeburn is doing some work on the commercial and the sales front in terms of sort of promoting Brixadi. We know that Indivior has a DTC program for SUBLOCADE. Is there anything similar for Brixadi or can you be a bit more perhaps specific on the specific things that Braeburn is doing to promote Brixadi?

Well, you are saying in this report with Braeburn does have and they're investing increasingly into direct-to-patient activities. I can't specify them. I mean they are going in various different routes of course via everything from social media to direct interactions. And that is an initiative that has been ongoing for some time and accelerated during the first part of this year. And as I understand it, it's an investment that is having some good traction.

Got it. That's clear. And then just 1 last one for me, please. When can we expect the full data for CAM2056 and in which format? So would it be a publication, a conference or perhaps both?

Both, yes, I would say second half.

Next question from Richard Ramanius from Redeye.

I just have 1 question. Do you assume significant revenue contribution from Oclaiz and Oczyesa in your 2026 revenue guidance? Or if I phrase it like this do you need revenue from Oclaiz and Oczyesa to reach your 2026 revenue guidance?

I think we have been pretty modest on that note. Maybe Anders, if you want to.

Yes. So that can definitely be covered within the spread we have in the outlook. So it's not like it's so heavy as you're signaling in our assumptions.

Next one is from Georg Tigalonov-Bjerke from ABG Sundal Collier.

This is Georg from ABG. I have a 2-part question on CAM2029 and GEP-NET if I may, please. So first, according to current tracking of a number of events, is the readout more likely to be announced towards the beginning or end of H2? And secondly, given a successful readout, I wonder if you can remind us of the timeline from this to market launch in the U.S. and Europe, respectively.

Yes. So in terms of the readout, as I said, we have a big data pool coming in later on this month. I think it's difficult to give you a more precise detail about when the event will occur. I would say very early in the second half is perhaps less likely. So if that's giving you some direction, that's probably as far as we can comment right now. And on the other topic, can you repeat that? Yes, the continued program. So I mean obviously a positive superiority outcome would position us extremely well in terms of demonstrating the performance of CAM2029 in GEP-NET.

And the regulatory path from there on would be an NDA application to the FDA and that would be submitted as quickly as possible post data. And I think we have a very tight process there in place. We believe that it's possible to have the approval based on our assumption within the fourth quarter of 2027. So that's the expectation based on our current understanding and regulatory review. In Europe, it will probably take a slightly longer time because of the assessment timelines. So it would be an initial launch and approval plan for the U.S.

Next one is Mattias Haggblom from Handelsbanken.

A couple of questions, please. First on the option for Lilly to include amylin as part of the June 2025 agreement. If Lilly decides not to pick up the option when it expires this summer, would you anticipate other interest for using FluidCrystal applied to amylin from external parties?

Yes. I think this is at this moment quite speculative. So I wouldn't really -- but obviously we will try to exploit our technology to its broadest application in indications which we consider are suitable. So when it comes to the specific case of amylin, let's wait and see how things evolve. We will be announcing any developments. I'm not sure where the timeline has been provided so that's a question I cannot confirm. But otherwise, I would say that we'll update on that if it would become relevant.

Could I rephrase maybe? So when you signed the deal in June 2025, was there a competitive interest except with Lilly to include increasing as part of FluidCrystal?

I mean we do have significant interest in different applications and mode of actions of course for the FluidCrystal technology and we did so also before signing the agreement, yes.

That's helpful. And then secondly, recent court documents tied to the ongoing legal dispute between investors back in your U.S. partner Braeburn show that there has been an offer made for Braeburn by an undisclosed party that was viewed unacceptable. So could you maybe use this opportunity to remind me where Camurus stands on its updated M&A agenda and key priorities?

Yes. I mean we remain focused on potential strategic assets of course and we are having ongoing activities on various different targets of course. However, we have said that it needs to have a clear fit for our further development in the company and so far we haven't announced anything. So that's an important point. Also we see some new opportunities in our pipeline. So we have and we will see the opportunity to invest further into both mid- and late-stage development potentially in our pipeline. So there will be some prioritizations to consider going forward, but definitely it's part of our agenda. And as you know, we have also now [indiscernible] on board and she will of course be -- part of her activities is related to that area as well as our strong BD group.

Next one from Dan Akschuti from Pareto Securities.

Just a follow-up that was briefly discussed already on Australia and also on the U.K. funding situation. So Australia, if we look at the numbers from back to '23, it was performing better than Q1 this year. If you could just share a bit more what has been happening over the past years, '24, '25 and this year. And then on the U.K. funding situation, it sounds promising. But as you noted yourself earlier, it has been quite tricky that the money actually is used in the clinics. If you have some more detailed knowledge on how it has been going since April.

Then one more general question if there is time and that is kind of the stickiness of the current solutions that compete with Brixadi non-long-acting solutions and what Braeburn is doing against that. And 1 more question. How many salespeople will actually be activated directly upon U.S. approval for Oclaiz in the U.S?

So on Australia, yes, I mean, the penetration is good in Australia. I think we have some in the region of 30% of total market share now on Buvidal and we maintain our leadership in the long-acting buprenorphine segment with above 80% share of that segment. So things are going on. That penetration is strong and you see growth rates slowing down a bit as you penetrate the market. I think there's still an opportunity in Australia. I still think we're seeing growth and we will continue to see growth. Q1 is a bit of an anomaly because of the seasonal distribution holdings in Q4 that normalized in Q1, but then we expect that to come back on Q2. So that will go.

In the U.K., yes, the funding is -- it's a good question. I mean last year they did announce the funding in income and one of the problems was that it was only a year's funding. This time it's committed for 3 years and I think it's very clear the government intends that to make its way to invest in treatment of opioid dependence. So we have much more confidence I think that that money will come to the clinics and it would take away some of the resistance I think of commissioners and clinics to start long-acting when they didn't have certainty about long-term funding. They now have that so that should take away that issue.

And if it was the U.S. sales force you said, I think we have talked about 20 people approximately in the sales force for Oclaiz post approval.

And they are already trained so they will be directly active or will they be trained after approval?

They will be active at the point of launch. So then the launch will occur within a relatively short time frame from the approval. But training will be -- active training will be implemented post approval.

There are no more questions from the telco. So I hand the word back to Fredrik for closing comments.

So thank you so much for listening into this call and looking forward to our update next time in July. It's been a pleasure today and thank you for the questions. With that said, we can close the call. Thank you.

Welcome to Camurus' Q4 Report 2025. [Operator Instructions] Now I'll hand the conference over to CEO, Fred Tiberg. Please go ahead.

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 Vadsholt, Chief Financial Officer; and Richard Jameson, Chief Commercial Officer.

So 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 U.S. 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 continue to build momentum with Buvidal and Brixadi, expanding their reach and impact across key regions. Importantly, the first of our new wave products, Oczyesa, received regulatory approval for acromegaly in both EU and the U.K.

Supporting our strategic expansion into the U.S., 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 SEK 2.3 billion. At the same time, profit before tax increased to just above SEK 0.9 billion, 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. Brixadi royalties in the U.S. showed strong year-on-year growth of 47% and increased 82% at constant exchange rate. Buvidal sales declined temporarily due to FX headwinds and the change in our U.K. distribution model. The launch of Oczyesa 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 Ib results for CAM2056. [Technical Difficulty]

[Foreign language] Yes, and now we seem to be back again. Yes, and we're back. You can continue now, Anders.

Okay. Thank you. Camurus reported quarterly revenue of SEK 464 million, down from SEK 553 million, a 16% decline compared to the same period last year, while quarterly product sales reached SEK 342 million, reflecting a 27% decrease. This reduction is primarily due to a change in the U.K. distribution model. Consequently, we repurchased SEK 93 million worth of inventory from our U.K. wholesaler.

Quarterly royalty income from Brixadi sales in the U.S. increased by 47% year-on-year, reaching SEK 122 million. A potential milestone payment from Braeburn relating to Brixadi sales is now expected in 2026. Full year revenue reached SEK 2.27 billion, up from SEK 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 U.S.

In R&D, we observed a 20% -- 25% reduction in cost during the quarter and a 24% reduction for the full year. This reduction results from the completion of clinical trials of 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 and administrative expenses is primarily due to a change in Camurus' internal cost allocation model.

And additionally, we have boosted our investment in digitalization throughout the organization. The operating result for the quarter decreased 32% to SEK 113 million, while the full year results increased with 86% to SEK 874 million. Buvidal sales and Brixadi royalty income mainly drove the increase.

Looking at the quarter's cash flow. The cash position increased by SEK 211 million, mainly driven by the operating activities, which contributed SEK 111 million and a change in working capital, adding SEK 144 million. Investment reduced cash by SEK 46 million, resulting in a net cash position of SEK 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 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. An additional SEK 200 million will be allocated to expanding U.S. operations in preparation of the planned Oclaiz launch mid-2026. And R&D expenses are expected to increase by roughly SEK 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 SEK 2.6 billion to SEK 2.9 billion, an increase of approximately 21%, operating result in the range of SEK 0.9 billion to SEK 1.2 billion, an increase of approximately 20%. The numbers are reported or measured at constant exchange rate.

With that, I would like to hand over to Richard.

Thank you, Anders. So I'll start with Camurus markets. As already stated, invoice sales were impacted due to a onetime accounting adjustment associated with the change to the U.K. 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.

And in the Nordics, where Buvidal continues to gain market share, which has increased by the competitor withdrawal from the market. And the U.K. 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 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 Buvidal, a net gain of 3,000 patients in the quarter.

There remains a significant growth opportunity to Buvidal 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, 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. So it 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. 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 programs that call for and drive improved patient access.

On the next slide, there 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, which we expect to drive growth in 2026.

So take these in turn, in the U.K., 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 the national and the 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 U.S. Brixadi continued its strong performance in the year with Q4 royalties of SEK 122 million, up 10% from previous quarter and 40% -- 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 U.S., this segment, the long-acting buprenorphine segment is now above SEK 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 we -- and Braeburn, our partner, continues to communicate the evidence base and the clear value proposition of Brixadi.

So overall, we remain optimistic about the prospects of Brixadi in the U.S. and the potential for significant growth in the coming years. And in parallel to this, we are preparing for the launches of Oczyesa 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 1 countries that have an estimated 4,000 to 5,000 acromegaly patients currently treated with first-generation SRLs. The response to Oczyesa 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 Oczyesa 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 U.K. and Norway, where we're now ready to launch.

And with the resubmission of the NDA for Oclaiz, we're also gearing up, as Fredrik said, for the U.S. launch mid-2026. The team is launched 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.

And 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. So 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 2 pivotal Phase III 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. Oczyesa, as we mentioned before, was approved both in the European Union and the U.K. in 2025, marking a major regulatory success in the year. Following this, we launched Oczyesa in Germany in the fourth quarter and broadening out our commercial presence in Europe.

Turning to the U.S. 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. And 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 U.S. approval and market entry shortly thereafter.

Moving over to GEP-NET and the ongoing Phase III study. As you know, SORENTO is the largest clinical study to date for GEP-NET using a somatostatin analog, 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 top line 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 USD 2 billion currently.

Finishing off with the 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 II meeting with the FDA scheduled for March to discuss the design of the pivotal Phase III study. In summary, we achieved significant progress with 2029 across the 3 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 results from our Phase Ib 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 Ib study design for CAM2056 with the 5 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. And going forward, our next steps will be to build on the promising Phase Ib results, we are actively preparing for a Phase IIb 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 auto-injector 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.

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 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 Oczyesa and Oclaiz for acromegaly in Europe and the U.S., 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.

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

The first question comes from the line of Romy O'Connor from Lanschot Kempen.

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 top line data still then estimated for mid to late 2026?

And the comments on the new auto-injector pen device. Can you provide any more color on this? Is this just for the CAM2056 asset?

Thank you, Romy. 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 CAM2056 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 CAM2056. Does that answer your questions?

Clear. Thank you so much. Yes, it does.

The next question is from Gonzalo Artiach from Danske Bank.

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 U.S. Could you give us some color on this on FX impact that you see there in the U.S., to trough is 17% headwind, if I understand correctly, on USD to Swedish krona, 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 Buvidal, but 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.

So 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.

Yes. So we've had a lot of fluctuation in the currencies during the year, primarily in the Australian dollar and the U.S. dollar, as you state. So it all depends on when we book, it is 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 yes.

Gonzalo, can you give me just -- is that -- can you repeat the second question?

Yes, it's on your 2027 goals or targets that you have disclosed in the past. And what do you have to say in terms of your margin approach? Are you still targeting around 50%, your EBIT margin? And on the top line, any words on that also?

Yes. So we established the vision for 2027 in 2022, and we are working concisely and with a high dedication to achieve that. Obviously, there is still ways to go, but we are -- we maintain our goals currently, including the margin goals of approximately 50%. I want to highlight that this is and remains a vision for the company.

The next question comes from Pauline Hendrickson, from Van Lanschot Kempen.

My question has already been answered.

The next question is from Christopher Uhde from SEB.

So my first question is just whether -- 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.

Anders, do you want to comment on?

Yes. So -- yes. So we have definitely taken the currency exchange risk into consideration when providing the guidance. So -- and then we've made a thorough analysis on several expectations for the development. And also, I would say, when we look into the U.S., this year, we predominantly have income. Next year, we're also beginning to have some expenses because of the buildup. So it's -- now it's a more natural hedge. But of course, we are very much exposed to the U.S. dollar.

Okay. That was the first one. Secondly, I noted that you had mentioned the milestone from Braeburn in 2026. So is it fair to assume that that's in guidance? And can you give us an indication of the size? Is it similar to the last one you got from them?

So yes, good question. Obviously, we did not realize the milestone in 2025. So that -- but there are good reasons to expect the first milestone. We haven't received any sales milestones yet from the collaboration, but it's good -- 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 3. So -- and the total amount is $75 million.

Okay. Great. Thanks. That's helpful. Then my next question is on -- so SORENTO, is it in the -- 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 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. 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? And I have other questions if it's okay.

I'll leave it over to Richard to explain.

Yes. So I mean, there's -- 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. And -- all right. So 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 U.K. 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?

Yes, sure. And good questions. I'll start with Germany then, is the one you mentioned there. So yes, 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 U.K., to answer your question there, it's -- we know Wales and Scotland are going very well. They have high penetration. They have funding available. 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 started mid this year, mid-'25 and is continuing. And hence, we're seeing the growth we're seeing in the U.K. coming mostly from prisons.

We know the U.K. government have now announced a 3-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 the funding can be allocated to long-acting buprenorphine to meet the demand that's there.

Okay. That's very helpful. Can you -- is it possible to kind of give us gating events that remain for these things to happen in both Germany and U.K. and France, like specific events that -- so we...

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.

The next question is from Viktor Sundberg, Nordea.

Yes, continuing maybe on the U.K. 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 if -- yes, when funding is expected to trickle down to clinics to improve the sentiment in the U.K.?

Yes, sure, sure. So there's no more stock in the channel to 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 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 second half. Is that fair?

I don't think we can say that now. I think there is potentially it could come. We know there's been a delay in '25 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 on -- in the U.S. here to keep in mind when you talk about competitive development that you mentioned in your guidance?

Yes. 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. And we don't see that there is a big differences from year-to-year, at least not from 2025. It's relatively stable landscape there. When it comes to Oczyesa, 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 relative -- 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 FluidCrystal maybe in general. You have had a lot of data pointing to that FluidCrystal 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 FluidCrystal enhanced semaglutide versus Wegovy? 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 IIb trial? Is it just more patients or any other key changes that we could expect?

That's a really good question. I mean when it comes -- I don't think we have talked about bioavailability specifically. What we referred to was that we had the same Cmax concentration with -- at a much higher dose with -- well, at a 4x higher dose with CAM2056 as the now approved product. So that's -- 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 IIb study, the main question will be to see how the weight reduction is developing over 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 will 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 III preparation development.

Next question from Oscar Haffen Lamm from Stifel.

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 Oczyesa in this guidance?

Yes. I mean we are -- as we said in the report, we are expecting Buvidal 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 U.S. and Braeburn with Brixadi development. So that's, of course, a very important component of the development or the expected development for 2026. I think we have to say that Oczyesa, 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.

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. Then another question. You maintain your objective of 100,000 patients on Buvidal by the end of '27. This will obviously mean a strong acceleration in the next 2 years, maybe higher than what you've shown in the past. So my question is, I mean, 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. I mean, as I said, we saw growth of 20% plus in the big European markets, so Germany, U.K., France, and Spain, and 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. So that's why we believe the 100,000 is still possible in that time. But it is predicated on some -- 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. What is currently the proportion of Buvidal sales are coming from the U.K.? 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.

Next question is from Georg Tigalonov-Bjerke from ABG Sundal Collier.

This is Georg 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 Oczyesa, when do you expect to launch in France, Spain, and Italy?

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

Yes, regarding, I mean, what kind of German patients, I mean, are you getting or adding at the moment that were...

Okay. Yes. I'll leave it to Richard.

The year-over-year growth, 20%. Yes.

I'll leave it to Richard.

Yes. 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 coming from there. So it's a mix. I can't say there's one specific segment or 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 1 countries. In parallel, we are doing our market access work for the rest of Europe. And we will kind of announce -- as you have seen for Buvidal, we have added countries now for -- we are in our 7th year, 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.

Next question from Dan Akschuti from Pareto Securities.

Just 2 more questions from my end. And 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? And are they happy with the data?

And the second question would be just on the inventory there that you got back for the U.K. How long is the shelf life for that? Or can you reallocate that to other geographies if the U.K. would take more time?

Yes. So on the first question, I have to say that we -- through our contractual relationship with Lilly, we have -- 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?

Yes. So yes, we can definitely sell the product continuously. So it's -- yes, so there's no question about that. So that's very simple applied to that one.

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

The next question from Mattias Haggblom from Handelsbanken.

I have 2. So I'm coming back to this 100,000 patient target. So 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?

And then secondly, for the vision of revenues of SEK 4.5 billion for 2027 shared back at the CMD in 2022, at the time, the composition was SEK 3 billion from Buvidal and SEK 1.5 billion from pipeline. When I look at it from consensus, it's largely at the SEK 4.5 billion level, but the composition is different, SEK 2.6 billion from Buvidal and SEK 1.9 billion from pipeline. So I'm curious to hear if you have any feedback or thoughts on that composition, at least in light of some of the pipeline contribution being delayed due to CDMO inspections as well as slower accrual events in the SORENTO trial.

You can start.

So 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'll 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 patients to reach the 100,000 in -- by the end of 2027, for sure.

And the SEK 4.5 billion, yes, I mean, 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 closer to where we were expecting it. We have uncertainty to how quickly the Brixadi sales will continue growing. We are hopeful there, of course. So those would be 2 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, we will need 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. 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.

Next question is from Erik Hultgard from DNB Carnegie.

The first is what drove your decision to change distribution model in the U.K.? And what impacted the timing of the decision, i.e., why now?

My second question relates to Oczyesa and the 20 patients that you have on therapy in Germany. Is this mainly switch patients? Or are you also getting naive patients? And where do the switches come from? Is it both Sandostatin and Somatuline or mainly Sandostatin switches?

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

Yes. So it came out from the volatility in the U.K. market. So that caused us to more or less aligned with the U.K. model with the rest of our distribution strategy. That's why we went to a different model and also because we have the upcoming launch of Oczyesa. But 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. So that was why we did it. And it made sense to do it by the end of the year. So it was very clear.

And on the Oczyesa patients, I would say that all of them were switches from both treatments. We should, of course, be aware that there was only basically a little, 1.5 months 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 would -- 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 there is a change now because, obviously, we had the whole situation with the change from the COVID times that was -- 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. And I don't think that that dynamic is left there. So we expect to see less of a dip in Q1, if any. It's -- I don't have that information, but I think that's the situation.

Gonzalo has a follow-up from Danske Bank.

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

Yes. 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 results expectations.

Christopher SEB also has a follow-up.

Two, if I may. So the first, just one clarification on the U.K. funding. Is there any kind of claw back or rollover on the funding that was allocated for '25? Or -- and if there would be a rollover, how would that impact 2026's funding allocation?

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 it -- 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 AMEA region. And I guess within that also, particularly Australia, how much more penetrated can long-acting injectables get in those markets?

Yes. I think there's still a reasonable 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 decline, but there's still -- we have 35% -- some in the region of 35% share for long-acting. So that means that 65% of people still available. Some of those will want long-acting.

Yes. I think we have said earlier that we believe that we could ideally or even potentially exceed that, that 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 -- it's continued developing very well in 2025, and we haven't seen any signs yet that that will be stopping.

The next question is from Shan Hama from Jefferies.

I've got 3, 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 that would look like for the momentum in 2026?

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

Okay. Understood. And then my next question, please, is with the end of Phase II conversation that you have with FDA in March for the PLD indication, where does that place potential Phase III start and therefore the timing of the costs for that study?

Well, yes, importantly, it depends, of course, on which response we get from the agency. And I mean, starting up a Phase III study and having the first patient treated, it typically takes at least 9 months and probably a little longer than that.

Understood. Make sense. And then just my final question, please. Could you just clarify the England funding situation? So 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? 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?

Yes. So there's 3 sources. Firstly, the NHS England funding for prison, so which is reasonably significant, is already in place in clinic and is driving growth in the U.K. 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 pool for access to long-acting buprenorphine is very clear from various sectors. And I think that we -- I think we're confident that it's going to come through in '26 at some time.

The last one is from Romy a follow-up from Van Lanschot Kempen.

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?

Yes. 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, U.S., or the more global setting. So that's the main target for us. So that would be in endocrinology, rare oncology, and potentially other rare disease indications, 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.

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 in and asking very insightful questions. Thank you.

Welcome to Camurus' Q3 Report 2025.

[Operator Instructions]

Now I will hand the word over to CEO, Fred Tiberg, please go ahead.

Thank you so much, Einer, and hello, everyone. Welcome to our third quarter earnings call. It's a beautiful autumn day here in Lund, Sweden, where we are sending this from. I will assume that you have read our forward-looking statements going forward here. So the agenda for the call today is as follows: we start with third quarter highlights, move on to financial and commercial performance reviews, followed by an update on R&D and then we'll finish off with the key takeaways and Q&A.

With me on the call today is Anders Vadsholt, Chief Financial Officer; and Richard Jameson, Chief Commercial Officer. During the quarter, Camurus delivered strong profitability, continued progress on pipeline programs and prepared for the launch of our next commercial product.

Starting then here with some highlights on the financial side. Our quarterly revenues increased by 18% year-on-year, 25% at constant exchange rates to SEK 575 million driven by higher Brixadi royalties. Profitability remains strong. We're growing 48% to SEK 245 million, increasing our cash position to SEK 3.5 billion. We maintained our profit guidance. However, due to the headwinds we have had, we have lowered our full year revenue guidance. The commercial performance in the quarter was mixed, you can say. Buvidal sales in Europe slowed down temporarily, primarily due to ongoing funding issues. While Brixadi reported double-digit sales growth quarter-to-quarter.

In parallel, we prepared for the launch of Oczyesa in the European markets. This has been progressing very well. On the R&D side, marketing approvals for Oczyesa that was received in the U.K., and we also updated the NDA draft for the Oclaiz submission. This is pending completion of an inspection of the contract manufacturer. We were also granted 2 new orphan drug designations of CAM2029 in autosomal dominant polycystic kidney disease. And in addition, the treatment was completed in the Phase Ib trial of our monthly semaglutide formulation, CAM2056. So all in all, the third quarter has presented both challenges but also very important successful developments and progress. And with this, I leave the word over to Anders to review the financial performance of the quarter more in detail.

Thank you, Fredrik. It's a pleasure to provide the first financial update after joining Camurus in July. I'm generally pleased with the financial performance in the third quarter. Camurus reported SEK 567 million in revenue for the quarter, reflecting an 8% increase compared to the same period last year. Year-to-date, the reported revenue is SEK 1.8 billion, representing a 37% growth from previous years. Product sales reached SEK 455 million, an increase of 8% compared to the same period last year, but a decline of 3% compared to previous quarter. We have experienced stable end market growth throughout the year, but the distribution model has caused some deviations in the timing of revenue recognition. Brixadi sales in the U.S. generated SEK 111 million in royalty income for the quarter, up 91% compared to the same period last year. and a 25% increase from the previous quarter. The company's profit before tax was SEK 245 million, representing a 43% profit margin in the quarter and a 48% increase in profit compared to the same period last year. The profit margin year-to-date is 45%. The profit after tax for the quarter was SEK 193 million, representing an earnings per share after dilution of SEK 3.19.

Moving to the P&L. The company's gross margin was 93.1% for the quarter. Total operating expenditures were SEK 298 million, 2% reduction compared to the same period last year. The main components were increased our investment in marketing and distribution by 27% to SEK 142 million to support market penetration, expanding Buvidal into new markets and building our U.S. operation. Recruitment of the U.S. sales force has been aligned with the new time lines for the launch of Oclaiz. Administrative expenses increased by 49% to support company growth and development, mainly in the U.S., reaching SEK 40 million compared to the same period last year. And then R&D investments were SEK 109 million, a reduction of 33% compared to the same period last year. This is mainly due to the completion of ACROINNOVA trials and the absence of trial -- clinical trial milestone payments in the SORENTO and POSITANO programs during the quarter.

Looking at the cash flow for the quarter. Camurus increased its cash position by SEK 167 million, mainly driven by the operational activities, adding SEK 221 million and proceeds from the employee stock option program, adding SEK 43 million. Working capital investments decreased to cash by SEK 97 million, resulting in a net cash position of SEK 3.5 billion, which is an increase of 28% compared to last year.

Moving to the update of the 2025 financial guidance. Despite positive development in Brixadi and Buvidal, revenue do not live up to our previous expectations and guidance for the full year is primarily due to Brixadi U.S. revenues below the previous projections and there's uncertainty about the timing of a sales milestone.

In addition, we have seen continued delays in allocation of committed governmental funding for the treatment in the U.K. But importantly, our profitability has continued to develop positively with good financial discipline across the organization and our planned U.S. expansion has been aligned with the updated approval timeline for Oclaiz. As a consequence, our restated full year 2025 outlook is as follows: our revenue guidance is lower to SEK 2.3 billion to SEK 2.6 billion, and the profit before tax is unchanged in the range of SEK 0.9 billion to SEK 1.2 billion. So nevertheless, Camurus ended the third quarter with a healthy financial position, promising outlook for continued growth, profitability and pipeline progress.

With that, I would like to hand over to Richard.

Thank you, Anders. I'll start with the Camurus market. So net sales for Buvidal in the quarter were SEK 455 million, up 8% year-on-year or 15% at constant exchange rate. Versus Q2, sales were down 3% primarily due to the lower-than-expected orders in the U.K., which also led us to reduce inventory levels. In contrast, underlying in-market sales grew 3% versus Q2 and are 21% year-to-date driven by maintained growth in Australia, Norway, France and Spain, as we continue to execute on our plans while we saw a flattening of growth in the U.K. and Germany due to 2 main factors.

In the U.K., there are ongoing delays in allocated funding reaching community clinics. However, growth began to accelerate in the criminal justice setting as allocated NHSE funding for long-acting injectable buprenorphine treatment in prisons has become available. In Germany, resistance to uptake remains due to the ongoing remuneration of physicians based on daily visits. Year-to-date in-market growth is positive, around 20% across markets with the exception of Finland, where growth was single digit due to the high penetration we have there. There continues to be high demand from patients and physicians for long-acting injectable buprenorphine and we continue to support this through active programs that build awareness of the benefits the product brings to patients and wider society.

This in turn is increasing demand for wider accessibility and is expected to deliver renewed growth in 2026. So on the next slide, I'll share more detail of our ongoing strategy for improving patient access. We are continuing to grow the real-world evidence base and develop economic models that demonstrate the improved outcomes and the value long-acting buprenorphine brings over daily treatments. The economic models, of which there are some publications on the left-hand side of the slide, clearly demonstrate the positive value of treatment with LAIB, typically showing a more than 3x return for governments. These data and models are a critical part of our initiatives to improve access through a government affairs program that is engaging a wide group of policy stakeholders who will benefit from improved access to these innovative treatment options.

As a result of these programs, we're seeing growing demand in criminal justice settings and the need for the community -- continuity of care on release, alongside support to address funding in community settings. This has already resulted in some success, including allocation and distribution of funding from the criminal justice setting in the U.K. that I mentioned earlier, and regional funding expansion in France. We also understand good progress is being made on alternative remuneration models in Germany that would address this key hurdle for Buvidal. The success of this activity is critical to expand the use of Buvidal these markets in 2026.

Now moving across to the U.S. Brixadi had a strong quarter, as you've already heard, with royalties growing 25% versus previous quarter and 91% year-on-year. Brixadi continues to outgrow the market and has reached an approximately 30% share of the long-acting buprenorphine segment, which in itself is growing 25% year-on-year and for the first time, reached annualized sales of USD 1 billion. In the U.S., Brixadi represents a significant opportunity for future growth through penetration of the sublingual buprenorphine market with an estimated 1.8 million patients in treatment and with further potential in the criminal justice setting.

Brixadi has a clear and differentiated profile and [indiscernible] are successfully navigating the challenges in the [indiscernible] treatment market. So overall, we remain optimistic about the prospects for Brixadi in the U.S. and the potential for significant growth in the coming years. And on this, I'll hand back to Fredrik.

Thank you, Richard. So let's move over to a quick pipeline update. So starting with the progress of the Octreotide programs for acromegaly, gastroenteropancreatic neuroendocrine tumors, GEP-NET and polycystic liver disease, PLD. So as you know and have heard before, we have a large clinical program for CAM2029, which represents a major investment and a future potential for Camurus. In acromegaly, we have successfully completed the ACROINNOVA program delivering positive results from 2 pivotal Phase III trials as well as long-term extension study.

In GEP-NET, we advanced the SORENTO trial towards the improved important readout of the primary efficacy results in 2026. Finally, we received complete -- we recently completed the POSITANO study in PLD, also that with positive results for the primary end point. I will start here with an update of the SORENTO study in GEP-NET. This was recently discussed that a well-attended scientific symposium at the North America Neuroendocrine Tumor Society meeting in Austin, Texas where it [indiscernible] significant attention among the participating physicians and other health care providers. The topic of the symposium was dose optimization of somatostatin receptor ligands, which is the efficacy driving hypothesis behind the SORENTO trial. So Chair of the symposium was Dr. Jennifer Chan, President of NANETS and presenter was Simron Singh, University of Toronto, who is the President elect of NANETS actually now the President of NANETS, both are SORENTO study investigators and steering committee members. The conclusion of this discussion was that there is very high hopes and good prospects for SORENTO and CAM2029, of course, providing positive outcomes. Patient recruitment in SORENTO started already in Q4 2021, which means that the first enrolled patients have now been in treatment for about 4 years, in many cases, without disease progression.

The study was fully recruited at the end of 2023, as all patients have been assessed for about 2 years or longer. So far, the experiences from the trial are generally very positive in terms of patient feedback and the projections for completing the randomized efficacy part of the trial has been extended based on the lower than predicted rates of progression-free survival events during the past few months. We recently completed a new analysis of the accrual rates in the study and based on the trends, we have updated the projections for reaching the 194 events for the study to mid or second half of 2026. From a CAM2029 and study outcomes perspective, the adjustments should be positive while also extending the time to primary results.

To put this in perspective, I would like to highlight the study design and patient population that is part of the SORENTO trial. So compared to previous studies of tumor progression, SORENTO is a randomized active controlled study with the primary objective to assess the superiority in progression-free survival for treatment with CAM2029 versus standard of care with first-generation somatostatin receptor ligands. It is indeed the largest average city of SRL performed in patients with the neuroendocrine tumor and majority, and this is an important point of the patients, SORENTO has advanced grade 2 or grade 3 neuroendocrine tumors at baseline compared to no or the minor portion of patients in the earlier tumor controlled trials, [indiscernible] and clarinet. The progression-free survival for the blinded population in SORENTO should be viewed in context of the study population, which makes us optimistic about the study prospects.

Moving over to PLD. During the quarter, we continued analyzing data from the POSITANO trial in preparation for an end of Phase II meeting with the FDA planned for early next year. Furthermore, CAM2029 was granted orphan drug designation for autosomal dominant polycystic kidney disease, ADPKD, both in the U.S. and EU during the period, pointing to the high unmet medical need in this indication. Importantly, this can also expand the future orphan drug exclusivity to PLD arising from ADPKD. So that is significant progress in itself.

Finishing off with the acromegaly indication, Oczyesa has now been granted market authorization for the treatment of acromegaly in both EU and the U.K. For the U.S., the NDA has been updated during the quarter and is ready for resubmission as soon as we have received green light from an inspection at the contract manufacturer. Please remind you said that there was nothing in the CRL from the FDA that was related to the product itself or its clinical or safety data. Based on our plans for resubmission, we expect a new PDUFA date and a potential U.S. launch of Oclaiz in the first half of 2026, which will, of course, be an important event for us.

In parallel, we are preparing for launches of Oczyesa in Europe, the first monthly subcutaneous octreotide medication in the market, enabling convenient self-administration for patients and enhanced doctor type plasma exposure. The European launch has been has now been initiated in the wave 1 countries with an estimated 3,000 to 5,000 acromegaly patients currently treated with first-generation long-acting somatostatin receptor ligands. The response to the Oczyesa profile from physicians and patients has so far been very encouraging with a positive view both on this and clinical data and market research that we have performed in the area show a high willingness to switch to Oczyesa from current somatostatin receptor ligands.

In addition to this, we have also had positive initial feedback from payers. So as you may have seen from the announcement earlier this week on Monday, Oczyesa has now been launched in Germany as the first country in Europe and globally. And our medical affairs and sales team are now out in the field. Germany represents a substantial opportunity with about 2,000 patients currently in treatment with first-generation somatostatin receptor ligands and with an annual sales potential of over EUR 50 million.

I recently performed physician survey suggests that about 30% to 60% of these patients are initially considered suitable for switching to Oczyesa. Obviously, GEP-NET represents a much larger opportunity. However, acromegaly is, of course, a great starting point here.

Alongside the advances of the CAM2029 program, we have also completed treatment of the last patient in the Phase Ib study where monthly semaglutide formulation, CAM2056 based on our [indiscernible] technology. We now expect to provide top line results this month. We'll focus on tolerability and of course, importantly, efficacy indicators such as body weight and HbA1C. In addition, we progressed our strategic partnership with [indiscernible] for the development and commercialization of long-acting infuse in the cardiometabolic area, including GLP-1, GIP dual agonists and GP1 [indiscernible] triple agonist. And we are naturally very excited about progressing this collaboration. So with this, I think it's time to finish off with some key takeaways of the quarter.

In summary, we had a good quarter as you have heard, not without challenges. However, we did significant advances in progress and expanded our business, delivering strong profitability and cash flow, stable Buvidal sales in Europe and Australia. I think our team are doing an excellent job also with regards to the future development in the market. Notably, Brixadi had another good quarter in the U.S., outflowing the rest of the market. In addition, for Oczyesa in acromegaly, we received the U.K. approval and prepared the launch in Germany. And also, as I mentioned recently here, we advanced our promising long-acting [indiscernible] pipeline. With this final note, I think it's time now to move over to Q&A. So please Einer, take over the call.

The first question is from Viktor Sundberg from Nordea.

Yes. So I had a question first on Buvidal. I just wondered if you could provide any more details when you expect funding to be released to clinics and when the market could turn around in the U.K., I mean just trying to get a feel for if this could spill over into Q4 as well or into early 2026 or how we should model this impact?

Yes. I will leave that over to Richard.

Yes. I mean funding is coming in drips and drabs here are some areas that are having funding now, others less so. So I can't guess what the government would do, but we hopefully will see some of ours in Q4 and then moving into 2026 as well on that. I mean, it is growing the U.K. market. We are getting more patients. It's just slower than we anticipated.

And also I had a question as you have launched of CSA now in Germany. Could you comment maybe how it's priced versus the other injectable to formulations on the market?

Yes. I think you could estimate that is priced at the high end of the Sandostatin reference products. So just -- so I think it's efficient price now.

It's just under EUR 3,000.

Yes, just under EUR 3,000 per dose.

Can you hear me?

Yes, we hear you.

A couple of questions on my end. The first one is for Buvidal in Europe. How many net patient additions were there in Q3? And are there any additional markets that recently came into play, for example, think of Portugal that they can support the future growth while the issue in U.K. and Germany persist.

Yes, certainly. I mean we reported a number of patients, 67,000. But Richard, maybe you can comment on the growth in the additional markets, Spain and...

Yes. I mean [indiscernible] making contribution. We grew to 2,000 patients between quarters this time. Portugal, yes, is really to come on. It's early days in that market. So we'll wait to see that. But yes, they will provide an opportunity for us as we move forward to grow the numbers of patients in treatment.

And we're seeing positive trends also in Spain where we are seeing big potential. And of course, we have further countries, including the Northern European part maybe this should also be put into the context of the dynamics of other movements in the Nordic markets and elsewhere, but it looks there is good growth potential.

Okay. Got it. And then maybe another one on Brixadi in the U.S. At last update, I think it was on Q4 last year. The numbers showed roughly 25% market share for Brixadi in the LAI market. Now it stands at 30%. Is this the market share of new patients switching from sublingual buprenorphine to LAI.

I think -- I mean the main components, and we have talked about that for quite some time is that most patients are coming from sublingual buprenorphine, of course. And depending on the relative growth in that segment, this will, of course, impact the market share between different products. So I would say the majority of the share is coming straight from sublingual.

Okay. I mean, the reason why I'm asking this is last week in Vivo reported a 75% market share. So I was just wondering on which metric you face this 30% market share.

So we have done used several different metrics, we should say, or different data sources and all of them converge into 30%. And that includes both public sources and also other sources that we have access to.

The next question is from Richard Ramanius from Redeye.

I have two questions on the guidance for this quarter. So I'll just read both questions straightaway. In your Q3 report, you guided for around SEK 650 million R&D costs in 2025. And so this was dropped in the Q3 report, so is this because the expected costs will be lower this year is just because you overestimated costs because some costs will be postponed into 2026?

And my second question is you lowered the guidance, should we say, implicitly from Braeburn since you don't expect the milestone, which I assume is revenue-based. Is that because of stronger U.S. competition or other market dynamics or both.

Yes. So shortly, so we're not pushing costs ahead of us. Of course, there will be something that are a bit delayed, but there's also been a number of savings in the R&D department. We're doing a tech transfer and so on. So it is a gas reductions and then some of the costs will come into 2026. So it's a mixed situation here. But it will be lower for the year.

Can you repeat? I missed the second question, sorry if we're not answering that.

So no problem. Implicitly, you guided for lower revenue from Wabun since you do not longer assume the milestone payment, which I assume, is related to revenues. Is that because of strong U.S. competition or just because of market dynamics?

I think it's mainly market dynamics. It's been -- I mean, we were expecting. We had, of course, very high expectations on the year, and those have come gradually down. But I think the good news is that we have seen a very good recovery here, especially now also consistent recovery. So -- but this -- in total, this has led to the milestone being at risk, which of course, it was not in the early phase of our assessment.

The next question is from Shan Hama from Jeffries. I think actually, it's [indiscernible], it's not Sean. So Sean, if you can queue up again.

I have one question. I was wondering if you could provide more color on your manufacturing expansion efforts in the U.S. I know you're planning further investments to deploy U.S. operations for acromegaly. I'm just wondering what your thinking is for GEP-NET next year and what your sales force will look like there?

Yes. I mean in terms of manufacturing, we have talked about that last quarter. All of those processes are advancing. Obviously, we have our current sources that we have need to secure future surprise, especially then when GEP-NET comes up. So that's an important part of the further development of gets, and that is progressing perfectly according to plans. So that's, yes, positive.

And then just maybe 1 more quickly. I was just wondering if you could share a bit on your future outlook for the Australian market with Buvidal because now you've reached 80% share, I think, of the LAIB market? Do you think this is reaching a plateau? Or do you see future growth here?

Richard?

Yes. I mean Australia continues to grow well. We have about 30% share of the total market now, as you said, above 80% of the long-acting segment. We still see that demand in Australia. We still see it growing. And there's a lot of people still on sublingual that are interested in moving across. And of course, methadone is a large segment as well, and we're seeing increasing numbers moving across methadone because the advantage is long-acting brings. So we anticipate continued growth in Australia.

Now we have Shan Hama from Jefferies.

Just two questions from me. I'll take them one at a time. So on the current readout, obviously, on the SORENTO readout. Obviously you know this has been pushed to sort of late 2026. It makes sense that this is because of the time to approve that. But are there any concerns that the control arm maybe outperforming such as, for example, when ibabrutinibs Phase III study read out in Obagi surprisingly outperformed.

Well, I mean, you can never come with guarantees on these things. So -- but in terms of -- obviously, we are using the literature reference data we are trying to compensate for populations and population characteristics and so forth. There is nothing new that has happened in terms of the standard of care changing -- in terms of treatment changes and so forth. So I think we should -- this should not be the case, but you can never be sure, 100%.

But I think our view is on this is -- and that's also our physicians input is that there has not been any material changes into the treatment regimen for the standard of care. So it's about trying to understand the different data sources. And I think we have a good indication.

Understood. And then just for my second question, could you just tell us what [indiscernible] communicated with respect to the [indiscernible] channel and the dynamics that will occur during 3Q on both the [indiscernible] side? And then what would it look like for 4Q?

Well, I mean, that leaves me with -- I'm sorry that because of the competitive situation, but also because of our contractual situation. I'm not able to go into any details on this note at this moment, Shan. I would, of course, want to, but I cannot fill you in on this.

The next question is from Jorg Tigalono BRK from ABG.

I have a couple. So first, I was wondering whether you or [indiscernible] have seen any size pressure for Buvidal or Brixadi lately? And secondly, your competitor Indivior for example, the Q3 reporting last week, they highlighted that [indiscernible] has a unique offering the long-acting lease category in terms of capital induction, i.e., second monthly dose injection after 1 week. So of course, [indiscernible] has a history of quite aggressive marketing. So I'm curious if you're able to comment whether or not do you think this is an actual significant distinguishing factor versus Brixadi in [indiscernible] Brixadi allows for reading initiation with the weekly dose injections.

So much. Well, to the first question about price, I don't think we have heard about any price pressure in the U.S. I mean it's -- obviously, the whole system has price. Price is an important increasingly important component. But I haven't heard of anything specific there or anything that is concerning to us. When it comes to the rapid initiation with [indiscernible] product. I don't prefer to kind of make judgments versus a colleague in the market here. I think it probably has some advantages for them. I think we have a very good treatment regimen as it is. We have the transfer doses from saving, which is the most important market places. We have the weekly at -- so we have all of this under control. We have -- was conducted a big study in emergency centers in the U.S. with over 2,000 patients using the weekly starts as a very successful measure to take taking over patients from in hospital treatment to outpatient treatment. So -- and plus it's used very regularly in the system. Do you have any further to say that, Richard?

Yes, you [indiscernible] to that. I mean, some of the feedback from some of the core research we've seen from various groups is that patients like start with weekly because they want to understand how it feels to be like on a long-acting before they commit fully to a monthly treatment. So I think the patient preference is for a month -- for a weekly initiation and our experience in Europe shows that.

I think most -- and most importantly, of course, we still see that we have -- I mean, it appears that we're -- our partner is doing a good job in the U.S. We are progressing CAM2029 -- sorry [indiscernible] we're progressing Brixadi nicely in the U.S. based on our competitive profile. And I think that holds a lot of advances compared to other products in the market.

And the next question is from Suzanna Queckbörner from Handelsbanken.

Suzanna Queckbö here, Handelsbanken. I have another question on Buvidal. So you have your target for 2027 of reaching 100,000 patients -- with the last few quarters of 2,000 patients net addition, we need to substantially accelerate to reach that going forward. Perhaps you could comment on how you think about that? And then also, is that possible in the markets that you currently have? Or will you need to make an address the regions where we've had budget constraints differently.

Yes. For first is, I mean, we still retain our vision for 2027 also in regards to 100,000 patients. Obviously, there are challenges and opportunities. Maybe, Richard, do you want to go into your thinking around this?

Yes. I mean it's not necessarily a linear approach as we create successful arguments to increase access, where you can see acceleration there. And we've got a number of processes that are ongoing in discussions with various groups that could still bear fruit to that. And our ambition is to achievable. And I think we have to remember that we still have relatively low penetration in this market at about 10% of patients. So there's still plenty of opportunity to grow the business, and we can if we can resolve the funding issues in the hurdles we faced, which we're on track to do.

And I think adding to that, I mean, obviously, we have great teams working in various different everything from government affairs to direct contacts with the [indiscernible] and so forth. And we generally have a very positive feed, but as Richard says, it will not be a linear curve up to the goal, and it will be a lot of hard work, but we retain our vision, and we are working hard to achieve it.

Very good. And then a follow-up on the liability deal. In the initial press release, you didn't mention anything regarding [indiscernible] that there was opportunity to expand, can you maybe just give us a little bit more on what progresses have been made recently and how you think about other impressions?

I can't give you any update because it's outside my remit, so to speak. But yes, I mean, obviously, they have an option to Amlin and usually, an option has a timely limitation coupled to it. So that's 1 of the components of our collaboration, which I think you can very nicely say that right now, it's progressing very well. But I can't give you any details on that beyond those 2 comments.

The next one is from Dan Akschuti from Pareto Securities.

I have just one more question. That is regarding 2056 as well. If you can share just some more details that you -- what you're expecting from the data readout this month and what you will be able to share in terms of detail of the data? Will it be just a press release with some top line or will you share a lot of graphs and details on PKPD, etc.

Yes. First of all, I think it's important to know the study design. So basically, design is 1 part which is a randomized part versus semaglutide. So the monthly versus the weekly. And then there is a second part of the study, which is basically a dose escalation part. So we're going from low to high concentrations of very high concentrations. So obviously, we will report comparative data focusing on the obviously, tolerability profile is important weight and PD readouts in terms of HbA1c and so forth.

So the traditional measures, it will most likely be provided in a press release form with some data points, key data points and then later on, we'll likely follow up with more detailed information about the product results. But -- so I think that's the order of that. But what is unique with this study is, of course, that we have an active comparator I think it's not that usually that you go into a Phase Ib study with an active comparative. So it will be an interesting readout from the study with, I think, clear clear potential to demonstrate something of relevance.

We have a follow-up from Shan Hama from Jefferies as well.

Just one more for me very quickly. Can we expect 2056 to be press released this month then? And could you just speak to how detailed that release will be? I know it's in Phase I, but any sort of color would help?

Yes. I mean, absolutely, our intention is, according to the current time lines and so forth, our intention is to be able to press release this month and the data, I mean, we will -- I think you can anticipate about the same level of detail as you see from other pharmaceutical companies working in the space for a Phase Ib trial or early Phase II trial. So I think that you should expect that level of detail approximately. Yes. Thank you.

There are no more questions at this time. So I hand the word back to you, Fredrik, Anders and Richard for closing comments.

Okay. Thank you so much. And I just want to say is, of course, thank you very much for joining into this call. It's a pleasure to have interest from you all and engaging questions. And I look forward to meeting you all on the road or at our next call in Q4 -- the Q4 report. And with that said, thank you again, and we can close the call.