Camurus AB (publ) ($CAMX)

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.