Thank you so much, and good day, everyone, and welcome to Camurus's 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'm 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 702 million SEK, up 4% year-on-year and 32% sequentially, with an operating result of 293 million SEK, corresponding to a 42% margin, and finishing with 4.1 billion SEK in cash.

Commercially, product sales reached a record of 528 million SEK. It's the first time we are above half a billion in a quarter.

Buvidal grew 12% year-on-year and 24% over the quarter. Brixadi royalties in the US increased 42%, and the Oclaesa launch continued in our first-wave European markets.

In the pipeline, we received a complete response letter for the acromegaly NDA in the US in June, which I will cover and come back to later in the presentation. Elsewhere, SORENTO continued progressing towards its primary analysis.

We advanced CAM2056 Phase 2b 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 445 million in Q2 '24 to 559 million in last year, and now reaching 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 Braeburn scales in the US.

Over the two-year period, marketing and distribution expenses rose from 108 to 175 million, reflecting our expanding commercial operations and sales growth. At the same time, R&D costs declined from 172 million to 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 result reached 293 million this quarter, up from 292 million last year.

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

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

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

This was partly offset by 104 million outflow in working capital, mainly due to the higher trade receivables and increased inventory to support the growing demand for Oclaesa, along with 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 200 million to expand our commercial activities, particularly for the US team to support the upcoming Oclaesa launch and to prepare for CAM2029 in GEP-NET.

Furthermore, we intend to invest additional 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 reaffirm 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 524 million SEK. 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, and UK 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 in 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. Now turning to the US.

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

That was up 20% sequentially. That makes it a record royalty quarter and a clear reacceleration 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 US 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 adjusting for posology, now holds about 30% of equivalent units.

Braeburn has made significant investment in its US 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 US.

Now moving across to Oclaesa. In Germany, the launch continued according to plan with 4 million SEK 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 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. Oclaesa is now available in Sweden with the first patient treated and with a September launch meeting, and formulary processes are progressing in the UK with the first outcomes expected later in the year.

On this note, I'll hand back to Fredrik.

Thank you, Richard, and let me first turn then 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 it's being communicated at various medical conferences and elsewhere. Oclaesa is approved in the UK and EU, and the European launch is underway.

In the US, the FDA issued a complete response letter for Oclaesa 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 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, 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 in NET 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 2 results were presented and recognized at this year EASL conference in Barcelona, a leading hepatology event. We hold orphan drug designations in the US and EU for PLD and ADPKD, and have completed the FDA end-of-Phase 2 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 3 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, and the regulatory submission package for the Phase 2b clinical trial has been prepared.

The study remains on track to start in the second half of the year, building on the positive Phase 1b data reported in November. Product design work is also ongoing in parallel, including the validation of an autoinjector 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 analogue 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 Oclaesa 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 2b, and the US resubmission pathway for Oclaesa, 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 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. 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? How should we look at these regions forward?

I'll continue with another question after.

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 UK 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 estimates, or how should we see this?

I think it's difficult to give any predictions about Q3. We don't expect to see, 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.

Perfect. One last question.

It's on the CRL in the US. Could you clarify what is the status of the contract manufacturer you are setting in the US 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 US line with your other partners there? Thank you so much.

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. 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 and 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 Oclaesa US 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. That means remediations in relation to the CRL we received on the 10th of June this year.

As these were, as we said, third-party related. On the other hand, there was a small point also on this oxygen scavenger, and that has been also addressed.

We are hopeful that we will have a resubmission confirmation as soon as possible. We're not giving any further details at this moment.

I think 2026 is clearly an opportunity.

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. 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. We are expecting the agency, most likely we'll do an inspection at some point.

Okay.

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

Yes, I understand. Thank you so much.

Hello there. Thanks so much for taking my questions.

I've got three if I may. Just to continue on the Oclaesa CRL, has the manufacturer communicated that they expect an inspection to definitely happen this time round 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. 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 US and what kind of commercial investments are being made there?

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. 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 UK 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, I think right now we have a process where we have a lot of contributors that behind our growth and we are expecting the UK to develop in a positive direction. It's difficult to give you any direct indications of when this, but we are already seeing some positive trends.

Overall, we think that would be helpful. Obviously there are also other discussions and processes ongoing, we will see how it evolves.

Far, it's looking positive. 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's withdrawing towards the end of this year. You now have 80% market share approximately, do you anticipate capturing those last 20% fairly 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?

I think it's important with continuity of care, and 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, 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 of a vast majority and it's happened in reasonably short notice. I would say that, yes, right shortly after the supply is out in end of '26, there should be a transition 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, and can you talk a little bit 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, to speak.

We see definitely we already have over 30% and adding the patients is about 36% of patients now currently standing on long-acting injectables, it has been a very successful entry into the market. Richard, do 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, getting in there, but we're working very closely with the clinics.

We're doing a lot of programs, for example, pharmacy injection, which release capacity in the clinics, because patients then can go to the pharmacy and have their injection of Buvidal. That's been a successful program in a number of states, and 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, so that is another positive source of potential growth and patients in the future.

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.

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 US launch of Oclaesa, but that's of course now been delayed.

At the same time, you know that you've beefed up your Australian sales force, and obviously you're busy rolling out Oclaesa in the EU. How should we model the cadence of SG&A over the remainder of '26 and into '27?

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.

Anders here. What we saw in the first half just to see it from our side is that we've prepared for the launch, of course, and then we had an increase also across the globe.

Half of the increase in SG&A came from the US and half from the rest of the world. No, it's a balance.

Of course, there were some upfront investments in the US, and that, of course, depend on when we will have a potential approval, when we'll 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 costs we normally take, and then capitalized it. It's around 20 million we've taken in the Q2 numbers for the R&D.

Thank you very much. Then, 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? 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 this is a recent news, but obviously there is somewhere around 4 to 5,000 patients that are currently standing on the other long-acting injectable product and they will reasonably be transferred over the time until the product is fully withdrawn on the market. I think, based on that, I think it's anybody's guess.

I think that's the fundamentals here, unless something surprising happens, but 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 going in taking that right now because it varies very much from quarter to quarter.

Thanks.

Australia is a very 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 2b sema 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,

yeah.

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

Thanks so much.

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

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

Then secondly, wondering if you've seen any recent net price changes for Buvidal or Brixadi?

When it comes to the first question on SORENTO, I think timing of results vis-a-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.

You can take...

On the pricing front 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, but generally in the market, the prices are very stable.

Great. Thank you.

Okay. Thank you, everyone, for attending the call.

It was pleasant, as always, and wishing you all a continued nice summer. Speak next time at Q3 or earlier.