Camurus AB (publ)

Now we'll hand the conference over to CEO Fredrik Thibard. Please go ahead.

Thank you, Einar, and hello, everyone. Welcome to our second quarter earnings call. Here are our forward-looking statements. So the agenda for our call today is a summary of highlights in the quarter, followed by financial and commercial performance reviews, then an update on the pipeline and business development before finishing off with Q&A. With me to provide the financial update is John Garay, CFO. Also present are Richard Jameson, Chief Commercial Officer, and Anders Walshorp, incoming CFO. Cameroon has had a successful second quarter with good performances across our business. Financially, we delivered all-time record revenues, high profitability, further strengthening our cash position for planned expansions and pipeline investments. And on the corporate side, we entered a strategically important license agreement for long-acting incretins with Eli Lilly, as you know, a world leader in cardiometabolic disease. Commercially, our teams continued execution with Bovidal growing in Europe and the rest of the world, Brixhadi regaining momentum after a quiet first quarter, and in the R&D pipeline, key milestones were achieved. Of course, the EU approval of Oxisa for the treatment of Acromegaly was a clear highlight, which is now the first of a new generation products based on our innovative fluid crystal technology. We also received positive results from the Positano study and also the AcroInnova extension trials. So with this notable progress, I hand over to John for actually his final review of our financial performance. So here, John.

Yes, indeed, Frederik. Thanks a lot, Frederik, and good afternoon, everyone. Camurus delivered strong financial performance in Q2, and I would like to share now the main highlights. Camurus achieved 676 million SEK total revenue in the quarter delivering a 52% growth compared to the same period last year. Product sales reached 470 million SEK, growing 17% versus prior year, but declining 3% versus prior quarter. Swedish Krunor appreciation impacted reported figures negatively by 6 points versus prior quarter and 9 points versus same period prior year. Bricsaddy sales in the US represented an 89 million SEK royalty income in the quarter, growing 100% versus prior year and 21% versus prior quarter. Shuri's Kronor appreciation has impacted negatively royalty reported figures by 11 points versus prior quarter. Company profit before taxes was 307 million SEK, representing 45% over sales and growing 195% versus prior year. Earning per share after dilution was 4.08 Swedish kronor, equivalent to a profit after tax of 245 million SEK in the quarter. Finally, our cash position was 3.35 billion SEK at the end of the quarter. Moving to next slide, we can see the main components of our profit before taxes. Company gross margin reached 93.9% in the quarter, representing an improvement of 106 basic points versus same period prior year. The improvement was driven by two major factors. Firstly, Brizadi royalty and license revenue from collaboration agreement with Lilly represented a 146 basic points positive impact. And secondly, FX represented again a negative impact of 40 basic points in the quarter. No material variances occurred in bubidal gross margin. Total OPEX reached 343 million SEG, growing 4% versus same period prior year, driven by following factors. Marketing and distribution investment to support market penetration in own territories, expansion of bubidal into new markets and US operations grew 2% to 133 million SEG, Administrative expenses aligned with corporate evolution to substantiate company development grew 118% versus same period last year to 52 million SEK. R&D investment reached 151 million SEK, representing a 13% decline versus same period prior year, driven by lower milestones in our ongoing clinical trials and acromegaly study ramp down. Company profit before taxes reached 307 million SEK, growing 195% versus prior year, representing 45% of ourselves. Company cash position at quarter end was 3.35 billion SEK. Camurus improved its cash position by half a billion SEK in the quarter, driven by two main factors. Firstly, company operations generated 349 million SEK. And secondly, a stock option program exercised by employees delivered 126 million SEK. Finally, other minor concepts, as mainly less liabilities update, represented a negative impact of 5 million SEK. As end of quarter, Camurus has no debt. All in all, Camurus closes first half of 2025 with a solid financial position interesting growth opportunities, and based on financial performance to date, the company maintains the full year guidance. Having said that, I would like to pass the word to Richard. Thank you everyone for your attention.

Thank you, John. So I'll start with an update in cameras markets and then move over to the US. So Boverdahl continued to grow in cameras markets, increasing 3% quarter on quarter and 26% year on year at constant exchange rates, with performance being led by Australia, Spain and the Nordics. At the end of the period, we estimated about 65,000 patients were in treatment with Boverdahl. Overall, Boverdahl sales are growing in accordance with internal expectations and are aligned with its contribution to our guidance. In the quarter, reported sales were affected by exchange rates with a 6% points impact and purchase order patterns from distributors and wholesalers, while in the UK there was a short-term delay in committed funding reaching the clinics. As part of our expansion plans for Boverdale, we also initiated the launch in Portugal, which has nearly 20,000 patients in opioid dependence treatment. The interest and the feedback from healthcare professionals have been very positive. We have a clear opportunity to gain meaningful market shares over the coming years. based on the current market development for booberdale we expect improved growth in the second half of the year as we address funding hurdles improve access to treatment and order flows are stabilized now moving across the us where brixardi gained momentum in the second quarter our royalties on net sales grew 21 versus the first quarter and reaching 89 million sec a quarter on increase of 32 percent a constant exchange rate The renewed growth reflects our US licensee Braver's continued execution and the easing of the first quarter headwinds, including seasonal prescription authorizations and the impact of last year's cuts in federal funding in the criminal justice system. Braeburn expects Brookside to continue its growth in the coming quarters, supported by state-level initiatives to expand and improve access to OUD treatments, and of course, long-acting injectable buprenorphine. Furthermore, the federal medical assistance percentage for Medicaid seems to remain unchanged at current levels, and the budget reconciliation bill exempt substance use of disorder patients from the work requirements. So on that brief update, I'll hand back to Frederick.

Okay, thank you, Richard. And then over to a pipeline update, starting with CAMP2029, which is under development for treatment of acromegaly, gastroenteropancreatic neuroendocrine tumors and polycystic liver disease. So in the quarter, we were pleased to receive a positive opinion from the CHMP recommending approval of Oxuisa, the EU trade name for CAMP2029 in acromegaly. This was followed by a final approval by the European Commission on the 30th of June for the indication of maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues. This is aligned with the product information of current standard of care with stanostatin and somatoline and provides a really good starting point for establishing Oxy-ISA as a first-line treatment of acromegaly. So in preparation for the launch in the first EU markets estimated to early 2025, we have been active meeting with stakeholders, including having advisory boards, engaging with payers, preparing commercial and medical affairs readiness. And we have had a significant presence at key scientific meetings to communicate AcroInova results and inform about our product. including at the European Society for Endocrinology meeting in Copenhagen in May, and at last week's International Pituitary Society Congress and the ENDO meeting in San Francisco. Overall, we're getting excellent feedback. This has included both oral presentations, posters, as well as educational programs. So adding to the existing evidence base for CAM2029, in the quarter we received new compelling results from an extension study of ACRINOVA2 from a subset of patients that were treated for an additional 12 months with CAM2029 to a total of two years. And these patients, they constituted two different groups, those who continued treatment with CAMP2029 directly after finishing the ACRINOVA2 main trial, that they are illustrated on the left side, and patients who were re-invited to treatment with CAMP2029 after an intermediate period back on treatment with the standard of care. The interesting thing with this study is that for both groups, clear improvements were seen in the response rate, IGF-1, below one time upper limit of normal after switching from standard of care to treatment with CAMP2029 for two or one years. Interestingly also, as you can see on the right hand side, a clear decrease in response rate was seen for re-invited patients when they were switched back to treatment with standard of care following a period on CAM 2029. And then this was of course reversed going the other way. So the improvement that we see in the response rate may very well be related to the high octreotide exposure provided by CAMP2029. It's of course potential and very interesting for other trials, including the Sorrento study. As in previous studies, treatment with CAMP2029 also resulted in improvements in acromegaly symptoms and treatment satisfaction. further emphasizing the potential benefits of the CAM-2029 treatment for patients with acromegaly. So in the quarter, we also received positive results from the Positano study in patients with polycystic liver disease. PLD is a rare genetic condition associated with progressive growth of cysts in the liver that can cause a range of symptoms and reduce the quality of life of patients. There is currently no approved treatment available for these patients. CAM-2029 has orphan drug designation for isolated autosomal dominant polycystic liver disease in the US and Europe. Applications are also under review for PLD associated with polycystic kidney disease, which is the larger proportion of patients with this disease condition. The Positano study was a 53-week randomized placebo-controlled three-arm study of two dose groups of CAM2029 versus placebo in patients who had symptomatic polycystic liver disease. The primary endpoint was the relative liver volume change from baseline to week 53 between the combined CAM29 groups and the placebo. Secondary endpoints included total cyst volume, kidney volume change, polycystic liver disease symptoms and quality of life scores, as well as pharmacokinetics and pharmacodynamics, including insulin growth factor one and safety, of course. So the study met the primary endpoint showing a statistically significant relative reduction of the height adjusted liver volume from baseline to week 53 of 4.3% with a p-value of 0.044 for the combined groups versus placebo. This was also supported by sensitivity analysis. The time evolution of the liver volume change versus placebo is shown on the figure on the right. Interestingly, in the study, we also measured the change in total liver cyst volume, which was suggested by the FDA as an alternative endpoint to total liver volume. This has, to our knowledge and also to our investigators, not been assessed in previous polycystic liver disease trials. As can be seen in the graph on the left hand side, the total liver cyst volume continued growing for 53 weeks in the patients on placebo, whereas it was stabilized in CAM 2029 treated patients. The relative change between CAM2029 and placebo groups increased, and that's on the right-hand side then, to a mean of 8.7, minus 8.7% at week 53 in favor of CAM2029 with a p-value of 0.016. Going forward, we are continuing to monitor these outcomes in the two and a half year extension study that is currently ongoing. So overall, we are really pleased with the outcome of the Positano study, which met the primary endpoint, as well as indicated other important outcomes, including the cyst volume, and provided symptom improvements as measured by CAMERA's own developed PLDS questionnaire and other patient-reported outcome measures. We also saw a robust decrease of plasma IGF-1 levels with CAM-2029 versus placebo. The safety profile was consistent with that of other injectable somatostatin receptor ligands and overall both treatment and study retention was high in the trial and all eligible patients chose to enter the two and a half year extension period after the court phase. In summary, significant progress was made during the quarter. In Acromegaly, the EU approval of Oxisa was the highlight. The corresponding application in the US is ready for resubmission. Following the announcement of an upcoming routine GMP inspection of the third-party manufacturer by national authority here in Q3, We have decided to appropriately await this inspection before submitting the NDA to the FDA. We believe the submission will be done during September. In Geppnet, the Sorento phase 3 trial has progressed according to plan. The randomized part of the trial is expected to be completed in the early part of 2026, as communicated earlier. Finally, as we already have alluded to in PLD, we are preparing for an end of phase two meeting with the FDA to discuss this design of a registration of phase three program of CAM 2029 in polycystic liver disease. So alongside the advances in the CAM 2029 programmes, we have progressed the phase one study of our once monthly semaglutide formulation, CAM 2056 in patients with overweight or obesity. The last patient visit is scheduled in the third quarter and results are expected in Q4. In addition, we have entered a strategically important collaboration, as noted before, a licensing agreement with LI Lilly for the development and commercialization of long-acting incretins in the cardiometabolic space. This license agreement includes up to four Lilly proprietary compounds, which are then selected from one of the three groups, dual-GIP GLP-1 receptor agonists, triple-GIP glucagon GLP-1 receptor agonists, and an option to include amylin receptor agonists. The agreement does not include our semaglutide development, which we intend to continue to develop separately from the Lilly collaboration. So in return for the agreement, Camrys is eligible to up to 290 million in license fees, development and regulatory milestone payments, 580 million in sales based milestone payments, and on top of that, a tiered mid single digit royalty on global net product sales. We are really delighted to enter into this agreement with Lilly and look forward to a productive and successful collaboration. To conclude, Cambridge had an excellent quarter with record high revenues. We received EU approval for our second commercial product Oxy-ISA in a new therapeutic area. Got positive results from both the Positano and the Acrinova extension studies. and signed a strategically important license agreement with Lilly. So with this, I would like to thank you all for listening and move over to Q&A. Einar, can you please take over the call?

Yes, thanks, Fredrik. As a reminder, if you wish to ask a question, please press pound key five on your telephone keypad. The first question is from Kristoffer Ude from SEB. Please go ahead. Your line is open.

Hi there, thanks for taking my questions. I have a few. The first one is on BRICSATI and I guess it's in sort of parts because I'm really just trying to understand the dynamics of the market there. So do you continue to expect an acceleration of growth over the remainder of 2025 and what can you tell us about the market dynamics in general and then in particular about what your or why your market share of injectable buprenorphine has plateaued and what steps can be taken to gain, grow share again. You mentioned in the report that the oral buprenorphine decline came as a result of injectables growth, sorry, sorry, sorry, that the, so did, what my question is, did the oral buprenorphine decline come as a result of injectables growth only?

were there other meaningful factors at play um thanks that's the first one uh thank you uh christopher well i mean overall in the u.s i mean i think the most important conclusion from this report is that growth is back in the u.s in terms of brixaris and it was a i think very strong quarter We were not sure how quickly this would return, but we are pleased with the growth that we have seen in the second quarter. Of course, the reason for this is a combination, as I indicated in the report, of the headwinds being largely overplayed in terms of the seasonal authorizations and the other points I raised in the previous quarter. And I think looking at the positive dynamics, there is a number of states that have prioritized substance use disorder treatment. I think it's 19 states that have initiatives ongoing to increase access to treatment. So I think that can certainly be one important component of the growth drivers. When it comes to market share, I think our most interesting question or the most interesting question is, of course, to gain share from sublingual buprenorphine because that's the bulk of the market and that's where we can grow. As regards to the share of the long-acting injectable space, I believe We have been in a static phase in Q1 and I think that will come and change over time. I'm expecting to see continued growth in the segment as well. But I think that's the response I have. Any further comments from the team here? Does that answer your questions, Kristoffer?

Yeah, that's great. If I could ask then a quick one on Oxias for Acromegaly in Europe, how should we think about the early ramp up?

So, I mean, we will follow a country by country approach similar to what we have done with Bovidal. So we see a large interest in the market, but obviously this is a smaller indication But the interest is very large. So, but it will be a country by country approach.

Okay, great. And then, so, Positano, what are potential conferences you're considering to submit an abstract to? And have you seen any signs of a dose response or differences between responses in ADPLD and ADPKD that you can kind of share?

When it comes to conferences, there are not any really important conferences in the late autumn or winter period. Our focus will be on the main event of the year, EASL. I think it will be in May next year. The abstracts are due, I mean, I think early January. So that's going to be our focus for the main results from the study. In terms of the response, we did not see a difference between the AD-PKD patients and the... So the AD-PKD associated PLD and the AD-PLD patients. Of course, you have to consider the fact that this was a small study, so you might have to have larger numbers, but our analysis did not show any difference between those patient groups.

Okay, and you had two dose levels, right?

Yes, and we will come into that later. In one parameter there is a difference, but we need to further understand that and whether or not it's more of a chance effect due to the small groups or if it is a real effect. But overall it seemed to be a similar response between the two dose groups.

Got it. And then my last question would be on just the in cretins so what was your spreadsheet to cta time if if i may phrase it that way for semaglutide and how long ago did you expand the development work to include other increases oh well i i mean in terms of we had a very rapid process from which was the start of our

our preclinical program for semaglutide and the clinical trial, but I don't want to go into that, but it was a quick process. And I assume that you are alluding to or thinking about the next steps and so forth. But I mean, ideally, it can be done quite quickly.

Okay. I mean, should we be thinking like a year or less or more?

I don't want to give... I mean, because if you're trying to use that for our partners' timelines, I think it's better to report them once they occur. But I think... Thank you so much. Thank you.

The next question is from Susanna Quekburnen from Svenska Handelsbanken. Please go ahead, Susanna. Your line is open.

Hello, thank you for taking my questions. I want to ask a few regarding Boveda. I noticed that you had 2,000 net additions of new patients in Q2. That's an average of 3,000 patients. And I think seasonally Q2 is also expected to be quite strong. So perhaps starting with that, maybe Richard, you could say a few words about that.

Yeah, sure. Yeah, I mean, underlying the demand remains strong, I think is the point to get across. I mean, it was affecting the quarter, as I said, by various factors, including some stock, the distribution of wholesalers and their ordering patterns. And there was a short term delay in the UK, as the committed funding by the government hasn't reached the clinics yet. But we're expecting that in the next three quarters, and that will accelerate from there. So yes, it was a little light, but I think we'll catch up going forward.

So this is a stocking effect and delay effect. It's not something representing saturation of the market or something like that.

That's correct.

Okay. As a follow-up question, I wanted to ask about the Eli Livy deal. Bearing forward, what kind of ability will you actually have to share progress in this? Are we going to get any press releases or is the new float completely owned by Eli Lilly?

Well, I mean, we will report material developments as a part of our obligations as a listed company and that will be things relating to revenue streams as well as major clinical events or clinical events, I would say. So we are expecting to be able to report continuously on more important events. But perhaps not on less so.

Finally, on your guidance that you haven't changed since the beginning of the year. Given the week-above BRICS value sales in Q1, But now the upfront payment for the ELA delivery deal, you haven't made any revisions. How should we think about the second half of the year? Is there going to be a clear pickup from both Buvedal and Brixardi, or how do you expect to reach your top line guidance?

So I think it's important that we have stated, you know, and this is also the information we have received from our partner in the US is that we are expecting growth to continue in the third and fourth quarter. uh richard just said that we are also expecting to see uh growth in the second half of the year for biblical so both of those are of course key considerations when we have reviewed our uh and updated our our guidance and and they are major components of that okay thank you

Thank you so much. The next question is from Sean Hama from Jefferies. Please go ahead. Your line is open. Ah, he disappeared. Your line is open. Victor?

Okay, yes. Thanks for taking my question. Yes, so a quick one maybe on Buvidal. You mentioned UK with a lane funding. Will that be back already in Q3 or will you believe that that will linger on for some more quarters? I didn't really understand your answer to an earlier question. It would also be nice to get any update on Germany and that reimbursement situation as well. Thank you.

Yeah, sure. I mean, so the government have committed the funding for treatment in opioid dependence for this coming year. And it really is just a bureaucratic slowness in that money moving from government departments into the clinic. So that's why we're positive that it's going to change. And we expect it to come in the next three quarters because the NHS year runs from March to April. So we certainly expect to see in the next two quarters this year a pickup as that money comes in. In Germany, we're progressing and we still have the same remuneration challenge, but we know there's movement. It's not something we're involved with, of course, but there's movement there to try and resolve that issue. There's ongoing pilots in a number of areas, so we're watching the space carefully on that and are expecting a resolution relatively quickly, hopefully.

Okay, thank you. And also a question here on the Vili deal. I know how much you can disclose around this, but I just want to get some more details around how this deal materialized. Did you speak to other parties here before this deal was done? And also in terms of the upfront at face value, you know, it's a great deal, but it just looks like the upfront is quite small compared to other deals done in this space. So any comment you can give on the rationale of the financial structure of this deal? the upfront versus the longer term milestone dynamic that because of the sales potential royalties that could come up from this in the future is that what attracted you and made you do the deal in the structure that you did rather than demand a bigger upfront etc. I just wanted to get some more details there if it's possible thanks.

Yeah sure I mean on the financials first of all on the financials I can say that we focus on on other things than the short term. Our financial situation is, as you see, strong. So we have focused on other aspects of the transaction. So that's the main reason for the milestones When it comes to other discussions, I cannot, unfortunately, Victor, as you understand, comment on that. But we are very pleased with the structure of the transaction that we have now because it fulfills our purpose with the deal. I can't say more than that.

Okay, I fully understand. And also the final question, I guess the market now, sees a bit more of your platform potential after the Lilly deal. So I just wanted to ask a quick question of your program with your gonadotropin releasing hormone agonist with fluid crystal. What's the next step here? What's the opportunity in terms of perhaps market size and met need, et cetera, especially in comparison with other current long acting formulations?

um you know camcv has you know every six months administration uh we'll also have a loop running this space etc i don't think i mean the comment here would be yeah to be to be quite frank it's not the focus area for us right now it's more of an opportunistic approach to that we have other developments that are prioritized

Okay, so any comments? What's next, do you think, in line after the programs that you have in focus here that you are prioritizing?

We will come up with that at our upcoming meetings, so we'll certainly prioritize that in short, but it's not the time for those announcements today.

Okay, thank you very much.

We'll be in a structured fashion. Thank you.

Sean from Jefferies, please go ahead. The line is open.

Hi, thank you. Just a few from me, please. So I believe, if I remember correctly, the aim was to have over 100,000 Buvidal-treated patients by 2027. Obviously, we're currently at 65,000. So that requires a bit of a step up if by 2027 means at the beginning of that year. which countries can we expect to actually drive this acceleration? And then what is the potential for a methadone switches?

So that's my first question. I think I'll leave that question to Richard.

Yeah, I think it's a good question. Our ambition still remains for 100,000 patients by the end of 2027. Clearly, we're working across the major geographies to try and address the funding and prove access to Buberdell. But I think what's clear is the benefit that Buberdell is bringing to patients, families and society. And there's no doubt that's continuing to build demand for the product. And that includes demand for the methadone segment as well. You know, we hadn't We've seen that with sublingual necessarily, but we're certainly seeing with Buvedal that patients are interested in moving over because the benefits that long-acting product preparations confer to patients. And we're very active at the moment supporting clinics on how to transfer. It's not such an easy transfer from sublingual, but we're supporting that through medical education and ongoing programs to help that. We continue to expand into new markets as well. I talked about Portugal. That's a big opportunity for us. So yeah, the 100,000 still remains our ambition. certainly still achievable, and we have some plans to try and address the hurdles that are preventing them.

Brilliant, thank you. And that was, you said, by the end of 2027?

Yes.

Okay, great. And then just on Brixardi, so where do you stand in terms of long-acting injectable buprenorphine market share versus your peers?

Well, I mean, the last time we have actually announced market share, and we'll see now, you know, once our peers have reported, but we said that it was in the region of 25%. So we haven't made any further developments there or talked about it. And that was, I think, in the end of Q4, in the Q4 report.

Understood. Thank you so much. And then just finally, sort of given your cash position strengths and particularly on the Lilly upfront, has that sort of increased your appetite for M&A or is the focus sort of on preserving optionality and reinvesting within the pipeline?

We are very active on the BD side and looking at different target opportunities. We are not looking to be a serial acquisitor, but we are definitely working hard on that. I think there are interesting opportunities. uh however they will not be communicated until they have been settled so to speak so so um but but we have a very active agenda ongoing got it thank you so much that's all from me the next question from oscar hoffenlam from stiffen please go ahead your line is open thank you for my question um

So my question would be, you know, how should we think in terms of Forex impact for the H2? So basically, you know, what type of impact are you seeing based on the current exchange rates? And then maybe as a follow-up, what was the exchange rate you did use for the current guidance? Thank you.

So, I mean, Oscar, so in terms of second half of the year FX impact, we are working with three banks. We usually review within the estimates every month. but we are not using any specific scenario we are simulating a number of scenarios and we know that we are in between these these scenarios in our guidance so we don't see any problem as as discussing prior earnings call we apply hedging we have a rolling hedging structure implemented already three years ago so that's why in profitability point of view we have limited impact on on fs fluctuation regarding the rates we use when we provide the guidance we don't disclose the rates we provide the guidance but we provide guidance at reported rates and the scenario is the same we work with rebanks we simulate something like 20 30 scenarios and we are pretty sure that we are inside those scenarios even today even in q2 with the head appreciation of should this crew not Somehow we were already anticipating it and we hedged for that. The main impact has been in US dollars, where we have been impacted by 11 points quarter on quarter. So the BRICS study growth more or less at constant rate is 32%. And the second one is Buvidal, where we have been impacted in Australian dollars, GBP pounds and euro, and is something like six pounds quarter on quarter.

So that's a bit of the overview.

Yeah, very clear. Thank you. Then maybe a second question on the PLD program. Do you already have some kind of idea what type of clinical endpoints you might be using in the upcoming phase three?

Yes, we have an idea and they will likely reflect the endpoints or at least some of the endpoints that we have been referring to today. Before going into that, we will await our end of phase two meeting with the FDA, which we are preparing for.

Okay, thank you very much. That's all for me.

The next question is from Georg Tegalon of Bjarke from ABG Sundal Collier. Please go ahead, Georg.

Hi, this is George Tegalon from ABG Sundal Collier. Thank you for taking my questions. I have one left. So given the recent development of the Bixali sales, could you perhaps provide some insight into when we might expect the first sales milestones from Braeburn? And does this to an extent factor into your decision not to revise the 2025 guidance? Thank you.

So the information that we have provided in regards to the milestones is that there are three milestones at different sales levels and all are within what we call very reasonable sales levels, whether or not they will be impacting This year I don't think we have had any discussions. Would you like to comment on that, John?

No, we have not disclosed if our guidance includes milestones or not. We are working closely with Brebon and we need to see the sales performance in the second half of the year and we will provide more information at the right time.

So that's the amount of information that we have available at this moment.

you okay with that george okay thank you yeah thank you the next question from christian glennie from stiffen please go ahead christian your line is open yeah hi guys uh thanks for taking the question follow up on the steeple side a couple please just maybe around some points of data point i guess clarification as much as you can so if we look at prescription data for brixardi in the us It's up about sort of 14, 15%, but you've done double or you implied sort of double that in terms of absolute sales. So is there something else going on here that might explain that disconnect? Is there other parts of the market maybe things like CGS is getting better or could there be some restocking going on here? Typically, you obviously see some destocking in Q1. Just trying to understand a bit of that disconnect or quite significant disconnect between what's showing in prescriptions versus what you're implied by your royalty number.

Yeah, that's a very good question. So, I mean, first of all, as we know, the numbers that CAMBI, IACUVIA and other data providers. It's a limited data set and it doesn't cover the full market, especially not specialty distributors. So that may be one source of the kind of disconnect between the data provider numbers and the numbers that we provide. Then I should of course also comment on the fact that our numbers are from our partner. So we haven't got full detail into the actual sources of all growth drivers and whether or not there is a component of re- or destocking in the data. I cannot comment on at this stage. We haven't had any signals of that. But I think the most important thing is that there is, generally speaking, a disconnect between the overall market and what is available through data providers.

Thank you. just in terms of just to clarify what you seem to be sort of implying as much as you're aware on on the sort of cgs part of the market the the funding the budget issues it seems to be you seem to be saying that sort of has has at least stabilized has it has it improved through the second quarter do you think i think it's i think the effect

uh has has absolutely stabilized but improvement this is difficult to to give you a view on right now so can you can you give me a little bit more clarity into your question and maybe i'm missing something oh you do you want to take more around you know we know that the so so i mean i think the important thing is that On the federal level, we know financing has not improved. The consequence of the reduction has disappeared. However, on the state level, there is a large interest in the CGS sector.

Fine, thank you. Another data point would be the minus 5% for oral buprenorphine in the second quarter. Again, as much as you can read across from IQVIA on orals, looks about flat in the second quarter. Obviously, you're referencing some claims data. Again, anything that might be different there in terms of the disconnect between those two. And are you in that same claims data? The implication is that LII has taken that share. Or is there something else that might be explained that minus five?

I mean, there is clearly a gain in share from LIS versus oral, at least in our data sets. Again, you know, there is quite a disconnect between also between data providers in their coverage. So I mean, I cannot say this is the data we are using. It's possible that IQVIA data or whatever you're referring to are representative as well, or maybe even more representative. That's not for me to say. But our data supports a slight decrease, but a better stabilized situation compared to Q1.

Okay. Thanks, guys. Appreciate it.

Before we go into the last questions, I just reconnect. We seem to have a short, short delay. So I reconnect the telco and we go forward in a second. Now we are ready to take Richard Romanious question from Redout. Please go ahead. Your line is open.

Good afternoon. I had two questions about your clinical development programs. Firstly, your Montesemaglutide, CAM 2056. Would you have to do a phase three study after the phase one before approving for an approval? And CAM 2029 in PLD. Could you give us some more details about the timeline for the phase three study?

Well, I mean, on the first question, We have not... I mean, there are possibilities to go into a larger study very shortly after the initial... Because this is really a phase 1b study. However, we haven't announced anything and we have a number of activities ongoing to further elaborate on that. When it comes to the second study on the PLD program, it will depend on the timeline and the amount of time that will be needed to kind of secure the as you saw in some data there is a continued increase between placebo and active so it will be depending on very much the outcome with the regulatory authorities so i i think that's at the level that we can communicate now we will update on this in the next quarter or at least in the next half of the year as things get more clear instead of speculating.

All right, thank you. Thank you.

The next question from Christopher Udo with a follow-up from SEB. Please go ahead, Christopher. Your line is open.

Hi, thanks for taking my follow-ups. Obviously, we've had some news from the Trump administration, I guess a little bit more clarity over the past quarter around Medicaid. And what can you tell us about your thoughts around the potential impact on the opioid dependence market from any changes in access as a result of Medicaid cuts?

So, I mean, Richard said that one of the important things is that the kind of Medicaid, the percentage remains, at least to our understanding, remains unchanged. So that is a positive. And then there has been the work requirement, which, to my understanding, the big, beautiful bill kind of exempts the substance use disorder treatments from population from that requirement. So that's also a positive. Then there is another detail on that, and that's the more frequent authorizations that would be required. But that's something that probably can be handled by the, you know, the stakeholders involved in the treatment.

overall i i think that you know it looks quite positive in the context of of the you know general political development in the us okay that's that's uh very helpful and then just one last one on the guidance just kind of following on from uh susan suzanne's question which was um uh so i mean if you have this 100 million milestone 115 million milestone that's almost 50% or 40% or so of the range on pre-tax profit. Is it a fair assumption that without that you would have had to lower the pre-tax profit guidance?

No, that's probably not a fair assumption. I would say that we haven't communicated whether or not the milestone was part of our original thinking. But you could very well consider that, so that's not the case.

Okay, thank you very much.

There are no more questions from the telco at this time, so I hand the board back to you, Fredrik, for closing comments.

Okay, thank you everybody. It's been a pleasure today and I'm sure everybody is looking forward to some relaxing weeks coming forward. Before ending I would just like to thank John for his contributions to these meetings over the years and it's greatly appreciated and we also welcome Anders of course to to take his place going forward. So great to have you. Thanks a lot. And with that said, I wish everybody a wonderful summer and speak to you in Q3 or before. Thank you.