Thank you so much, and good day, everyone, and welcome to Camurus' second quarter 2026 results call. Thank you for joining us.

Before we begin, please take note of our forward-looking statements which apply throughout today's presentation. Turning to the agenda, we will start with highlights, moving over to financial and commercial performance reviews, before finishing with a short R&D pipeline update, key takeaways, and then, of course, Q&A.

With me on the call today are Anders Vadsholt, our Chief Financial Officer, and Richard Jameson, our Chief Commercial Officer. Let me start with some highlights.

I am very pleased to report a solid second quarter, marking a clear return to growth after a softer start of the year for Camurus. Total revenues were SEK 702 million, up 4% year-on-year and 32% sequentially, with an operating result of SEK 293 million, corresponding to a 42% margin and finishing with SEK 4.1 billion in cash.

Commercially, product sales reached a record of SEK 528 million. It is the first time we are about SEK 0.5 billion in a quarter.

Buvidal grew 12% year-on-year and 24% over the quarter. Brixadi royalties in the U.S.

increased 42%, and the Oczyesa launch continued in our first-wave European markets. In the pipeline, we received Complete Response Letter for the acromegaly NDA in the U.S.

in June, which I will cover and come back to later in the presentation. Elsewhere, SORENTO continued to progressing towards its primary analysis.

We advanced CAM2056 phase II-B preparations. Lilly expanded our collaboration by exercising its option to include amylin receptor agonists.

With that, Anders will now take over and go through the financials.

Thank you, Fredrik. The financial figures clearly demonstrate strength, which is encouraging.

Looking beyond the headline numbers presented by Fredrik, if we strip out the one-off milestones, our underlying product and royalty revenue has grown from around SEK 445 million in Q2 2024 to SEK 559 million last year, and now reaching SEK 655 million this quarter. This reflects a compound annual growth rate of around 21%, with Buvidal showing stable growth and Brixadi royalties almost tripling as favor and scales in the U.S.

Over the two-year period, marketing and distribution expenses rose from SEK 108 million to SEK 175 million, reflecting our expanding commercial operations and sales growth. At the same time, R&D costs declined from SEK 172 million to SEK 125 million following the completion of multiple trials, signaling a favorable change in our cost structure as we shift towards a commercial execution.

Administrative costs have increased to support the higher level of activity. Regarding profitability, the operational results reached SEK 293 million this quarter, up from SEK 292 million last year.

Although year-on-year figures appear similar, they conceal an improvement. Last year figure included a significant milestone of SEK 150 million, whereas this year's milestone was SEK 46 million.

The core margin is clearly improving. Earnings per share were SEK 4.05.

Our cash position at the end of the quarter was SEK 4.1 billion, up from around SEK 3.9 billion at the start, reflecting a rise of approximately SEK 190 million. The primary factor for the net cash flow came from the operating activities, which contributed SEK 338 million before working capital adjustments.

This was partly offset by SEK 104 million outflow in working capital, mainly due to the higher trade receivables and increased inventory to support the growing demand for Oczyesa, along with SEK 41 million invested primarily to set up a second manufacturer. Importantly, we remain debt-free, which gives us real flexibility as we look ahead.

Regarding capital allocation for the rest of 2026, our main priorities are clear: to finance the organic growth of the business, including commercial expansion and pipeline development, while maintaining a strong and flexible balance sheet to support partnerships and business opportunities as they emerge. On the cost side, we initially allocate additional SEK 200 million to expand our commercial activities, particularly for the U.S.

team, to support the upcoming Oclaiz launch and to prepare for CAM2029 in GEP-NET. Furthermore, we intend to invest additional SEK 150 million in R&D for the planned new clinical trials.

These investments will be funded from our own cash flow. Despite the CRL for acromegaly, we affirm our full-year guidance.

With that, I'll hand over to Richard for the commercial update.

Thanks, Anders. I'll start with Buvidal.

In Q2, Buvidal delivered a record quarter with net sales of SEK 524 million. This is up 12% year-on-year and 24% sequentially.

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.

The 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. Buvidal remains the clear leader there with over 80% of the LAIB 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 are on track towards the 100,000 patient ambition by the end of 2027. Turning to the U.S.

Brixadi continued to grow well in the U.S. Royalty revenue rose 42% year-on-year to SEK 127 million.

That was up 20% sequentially. That makes it a record royalty quarter and a clear re-acceleration after the seasonal softness we saw in the first quarter.

Demand was solid across office-based care, treatment centers, and correctional facilities. Importantly, this growth is happening in an expanding market.

The U.S. long injectable segment is now estimated to be around $1.2 billion on an annualized basis and growing more than 30% year-on-year.

Yet it still represents about only 10% of the roughly 2 million patients treated for opioid dependence with buprenorphine. That leaves substantial room for conversion to long-acting therapy.

Within this segment, we estimate Brixadi, based on preliminary company data and adjusted for methodology, now holds about 30% of equivalent units. Braeburn has made significant investment in its U.S.

organization this quarter too, expanding both the commercial field force and medical affairs to support that growth. Taken together, an expanding market, growing share, and increased investment behind the brand, we see substantial further growth potential for Brixadi in the U.S.

Moving across to Oczyesa. In Germany, the launch continued according to plan with over SEK 4 million sales in the quarter and very positive patient and physician feedback.

Our focus for the second half is broadening adoption and moving towards a double-digit share of acromegaly patients on somatostatin receptor and agonists. The commercial capabilities we're building here are also helping prepare the ground for CAM2029 in GEP-NET.

The rollout is also extending beyond Germany. Oczyesa is now available in Sweden with the first patient treated and with a September launch meeting, and formulary processes are progressing in the U.K.

with the first outcomes expected later in the year. On this note, I'll hand back to Fredrik.

Thank you, Richard. Let me first turn to the pipeline where CAM2029 remains the central near-term value driver for us.

CAM2029 is a broad opportunity built around a long-acting octreotide with potential across acromegaly, gastroenteropancreatic neuroendocrine tumors, and polycystic liver disease. The key point is that this is not a single indication asset.

It's a drug compound and delivery platform with multiple clinically validated opportunities. In acromegaly, the ACROINNOVA 3 program is completed and is being communicated at various medical conferences and elsewhere.

Oczyesa is approved in the U.K. and E.U., and the European launch is underway.

In the U.S., the FDA issued a Complete Response Letter for Oclaiz 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, a 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 a somatostatin receptor ligand in GEP-NET to date and is our most important pipeline catalyst this year.

The study has been fully enrolled since the end of 2023, 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 in that would support the compound as a new first-line treatment option, opening a very meaningful new growth avenue for Camurus.

Finally, in polycystic liver disease, the positive POSITANO phase II results were presented and recognized at this year's EASL conference in Barcelona, a leading hepatology event. We hold orphan drug designations in the U.S.

and E.U. for PLD and ADPKD and have completed the FDA end-of-phase II meeting this year, 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 FluidCrystal technology.

During the quarter, we completed a type B meeting with the FDA, the regulatory submission package for the phase II-B clinical trial has been prepared. The study remains on track to start in the second half of the year, building on the positive phase I-B data report in November.

Product design work is also ongoing in parallel, including the validation of an 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 agonists that we had already started.

We view this as a further external validation of the FluidCrystal 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 two 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 Buvidal and Brixadi, and advancing the Oczyesa launch in Europe, strengthening the readiness and broadening the CAM2029 commercial efforts.

Second, advancing our pipeline with multiple near-term catalysts. The SORENTO readout in GEP-NET, the start of CAM2056 phase II-B, and the U.S.

resubmission pathway for Oclaiz, 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. 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.

Einar, with that said, we are ready for the first question.

Hi. Thank you very much for taking my questions, and congrats on the good quarter.

My first question is on Buvidal. You mentioned in the report strong performance in Nordics, Germany, Spain, and 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? I'll continue with another question after.

Okay. I'll leave it to Richard just 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. Thank you very much.

One question on Q3. 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. Generally speaking, we have seen in the past years, we have seen relatively okay Q3 developments.

I think it's too early for us to give any other indications.

Okay, perfect. One last question.

It's on the CRL in the U.S. Could you clarify what is the status of the contract manufacturer you are setting in the U.S.

right now? I know you cannot give much details right now, but what would be the reasons to remain in the contract manufacturer you have in Europe on the back of the two CRLs you have gotten and not moving straight to the U.S.

line with your other partners there? Thank you so much.

Well, I think that, to be frank, our current manufacturer has been capable and able to deliver. Unfortunately, we have this CRL, that's something we are accounting for, but strategically we have decided to build out and make sure that we are not sitting with one single manufacturing unit.

We need to have broader capabilities, that's the reason. 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.

Great. Thank you very much.

Yes. Hi, this is Zoe on for Romy.

Thank you so much for taking our questions. I have two questions.

You noted that the outstanding FDA comments have been addressed and that a further regulatory update is expected soon for the Oclaiz's U.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?

From our standpoint, the remediations have been completed, and that means remediations in relation to the CRL we received on the 10th of June this year. As you know, these were, as we said, third-party related.

On the other hand, there was a small point also on this oxygen scavenger, that has been also addressed. We are hopeful that we will have a resubmission confirmation as soon as possible, we are not giving any further details at this moment.

I think 2026 is clearly an opportunity.

Okay. Thank you so much.

My second question is: Are you able to outline the differences between the two CRLs that you received?

Not really, because essentially they were very similar in the sense that there had not been an inspection, and therefore you can say that the earlier remained. That's the situation.

We believe the manufacturer has been in contact with the agency, we believe that this communication and also provided inspection readiness declaration. We are expecting the agency most likely will do an inspection at some point.

Okay. Thank you so much.

It's obviously on the table of FDA and not us.

Yes, I understand. Okay.

Thank you so much.

Hi there. Thanks so much for taking my questions.

I've got three, if I may. Just to continue on the Oclaiz CRL, has the manufacturer communicated that they expect an inspection to definitely happen this time around?

Is that still uncertain?

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

Understood. Then my second question, please.

Is there a ballpark figure you could provide us with on the size of the Braeburn 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 say that they have made a significant addition to both its commercial customer-facing sales force and medical in the last quarter.

Size-wise, they are currently on par with other companies in the space.

Understood. My final question, if I may.

At what point during the year will you get further visibility into supply for Buvidal to the U.K.? As in, should we be expecting an acceleration in the second half of this year based on your current visibility?

I think as Richard said, 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.

It's difficult to give you any direct indications of when, but we are already seeing some positive trends. Overall, we think that that will be helpful.

Obviously there are also other discussions and processes ongoing, so we will see how it evolves. 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.

Thanks so much.

Hi, good afternoon. 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.

Firstly, just on the competitor here that we're withdrawing towards the end of this year. You now have an 80% market share, approximately.

Do you anticipate capturing those last 20% fairly quickly during 2027? How should we think about the dynamics there?

Do you think some patients will switch back to oral, for instance?

I think it's important with continuity of care, we are doing what we can on the medical side to make sure that we assist in any necessary transfers. What we have seen in previous transfers in the Nordics, for instance, it's been largely most patients have been transferring over to Buvidal, and it's gone, according to our reports, very swiftly.

If we see the same trend as we have seen in the European countries, it should be a vast majority, and it's happened in recently short notice. I would say that, yes, shortly after the supply is out in end of 2026, there should be transitions secured.

Okay. Very good.

Then just on the overall long-acting market in Australia as well. I think you stated you have 31% share of all patients now on buprenorphine in Australia.

You previously talked about a possibility of reaching about 50%. Are you still feeling confident about that?

Can you talk a little what specifically needs to change for the market to expand to that level?

I can start and leave it over to Richard. I think that the 50% is what we have seen is somewhere.

That's a scenario in the future, so to speak. We see definitely, we already have over 30%, and adding in the patients is to about 36% of patients now currently standing on long-acting injectable.

It's been a very successful entry into the market. Richard, you want to?

No, Australia is still growing, even without the opportunity with the other long-acting being withdrawn. It's still growing.

There are some capacity issues in the market. It's about patients accessing treatment per se, not there, but we're working very closely with the clinics.

We're doing a lot of programs, for example, pharmacy injection, which relieves capacity in the clinics because patients then can go to the pharmacy and have their injection and move on. That's been a successful program in a number of states, we're rolling that out further as well now.

Maybe I should add to that also that in Australia, there's still about 40% of patients that are being treated with methadone. We're seeing an increasing flux of patients from methadone over to buprenorphine.

That is another positive source of potential growth and patients in the future.

Okay, thanks. Perhaps lastly, just related to that.

You stated year-to-date growth in Australia was 6%. Is it reasonable to expect that staying in the single digits due to this capacity constraints in the near term, or do you see 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, thanks. That's all from me.

Christopher Uhde. Thank you very much for taking my questions.

My first one is on your SG&A. It was up sharply, as was expected, I guess, ahead of presumptive U.S.

launch of Oclaiz, but that's of course now been delayed. At the same time, you've beefed up your Australian sales force, and obviously you're busy rolling out Oczyesa in the E.U.

How should we model the cadence of SG&A over the remainder of 2026 and into 2027? Consensus is modeling a 30% year-on-year increase in 2027 to 30% of sales.

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

Yeah. Anders here.

What we saw in the first half, just to see from our side is that we prepared for the launch, of course, we had an increase also across the globe. Half of the increase in SG&A came from the U.S.

and half from the rest of the world. It's a balance.

Of course, there were some upfront investments in the U.S., and that of course depend on when we will have potential approval, when we will hire the sales force. 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. That has offset some of the cost we would normally take and then capitalize it.

It's around SEK 20 million we've taken in the Q2 numbers for the R&D.

Okay. Thank you very much.

You've said Indivior, of course, has about 20% share and obviously plans to be out of Australia. 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. 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 this is a recent news and we have not. 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 fully withdrawn in the market.

I think based on that, I think it's anybody's guess, but I think that's the fundamentals here. Unless something surprising happens.

I have difficulty being more precise than that. Richard, the follow-up question there.

Could you remind me what the question was?

Ex-Europe sales, what proportion is Australia?

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

Okay, thanks.

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

Thank you. If I could just ask one more question, it would be on the phase II-B CAM trial.

Can you tell us now about the design and particularly the size, duration, and dose levels, please?

We will give an update as soon as we have that approved and on track. That should probably come relatively shortly.

We will update on this.

Thank you very much.

Thank you. It will be a placebo-controlled trial this time.

Thanks very much.

Hello, this is Georg from ABG. Thank you for taking my questions.

I have two, please. First, regarding SORENTO, can you clarify if also the announcement of the initial data can be expected in Q4?

Secondly, if you've seen any recent net price changes for Buvidal or Brixadi.

When it comes to the first question on SORENTO, timing of results vis-à-vis timing of reaching the events. Obviously, it will depend on when we reach the target number of events.

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.

Yeah, you continue.

On the pricing one of Buvidal and Brixadi, they're pretty stable. There is, of course, a country mix that comes into play depending on the volumes in each country.

Generally, in the market, the prices are very stable.

Okay, great. Thank you.

Okay. Thank you everyone for attending the call.

It was pleasant as always. Wishing you all a continued nice summer.

Speak next time at Q3 or earlier.