Now we'll hand the conference over to CEO Fredrik Tiberg. Please go ahead.
Thank you, Einar. Hello, everyone. Welcome to our second quarter earnings call. Here are our forward-looking statements. The agenda for our call today is a summary of highlights in the quarter followed by financial and commercial performance reviews, an update on the pipeline and business development, and finishing up with Q&A. With me to provide the financial update is Jon Garay, CFO. Also present are Richard Jameson, Chief Commercial Officer, and Anders Vadsholt, incoming CFO. Camurus had a successful second quarter with good performances across our business. Financially, we delivered all-time record revenues, high profitability, and further strengthening of our cash position for planned expansions and pipeline investments. 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 Buvidal growing in Europe and the rest of the world, Brixadi regaining momentum after a quiet first quarter, and in the R&D pipeline, key milestones were achieved. The EU approval of Oxyceisa for the treatment of acromegaly was a clear highlight, which is now the first of a new generation of products based on our innovative FluidCrystal technology. We also received positive results from the Positano study and the AcroNova extension trials. With this notable progress, I hand over to Jon for his final review of our financial performance. Here, Jon.
Yes indeed, Fredrik. Thanks a lot, Fredrik. Good afternoon everyone. Camurus delivered strong financial performance in Q2 and I would like to share now the main highlights. Camurus achieved SEK 676 million total revenue in the quarter, delivering a 52% growth compared to the same period last year. Product sales reached SEK 470 million, growing 17% versus prior year but declining 3% versus prior quarter. Swedish krona appreciation impacted reported figures negatively by 6% versus prior quarter and 9% versus same period prior year. Brixadi sales in the U.S. represented an SEK 89 million royalty income in the quarter, growing 100% versus prior year and 21% versus prior quarter. Swedish krona appreciation has impacted negatively royalty reported figures by 11% versus prior quarter. Company profit before taxes was SEK 307 million, representing 45% over sales and growing 195% versus prior year.
Earnings per share after dilution was SEK 4.08, equivalent to a profit after tax of SEK 245 million in the quarter. Finally, our cash position was SEK 3.35 billion 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 basis points versus same period prior year. The improvement was driven by two major factors. Firstly, Brixadi royalty and license revenue from collaboration agreement with Lilly represented a 146 basis points positive impact and secondly, FX represented again a negative impact of 40 basis points in the quarter. No material variances occurred in Buvidal gross margin.
Total OpEx reached SEK 343 million, growing 4% versus same period prior year, driven by the following factors: marketing and distribution investment to support market penetration in owned territories, expansion of Buvidal into new markets, and U.S. operations grew 2% to SEK 133 million. Administrative expenses aligned with corporate evolution to substantiate company development grew 118% versus same period last year to SEK 52 million. R&D investment reached SEK 151 million, 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 SEK 307 million, growing 195% versus prior year, representing 45% of our sales. Company cash position at quarter end was SEK 3.35 billion. Camurus improved its cash position by half a billion SEK in the quarter, driven by two main factors.
Firstly, company operations generated SEK 349 million and secondly, a stock option program exercised by employees delivered SEK 126 million. Finally, other minor concepts as mainly less liabilities update represented a negative impact of SEK 5 million. At 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, Jon. I'll start with an update in Camurus' markets and then move over to the U.S. Buvidal continued to grow in Camurus' 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 estimate about 65,000 patients were in treatment with Buvidal. Overall, Buvidal 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% impact and purchase order patterns from distributors and wholesalers, while in the U.K. there was a short-term delay in committed funding reaching the clinics. As part of our expansion plans for Buvidal, 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 has been very positive. We have a clear opportunity to gain meaningful market shares over the coming years. Based on the current market development for Buvidal, 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 to the U.S., where Brixadi gained momentum in the second quarter, our royalties on net sales grew 21% versus the first quarter and reached SEK 89 million, a quarter-on increase of 32% at constant exchange rate. The renewed growth reflects our U.S. licensee Braeburn'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 Brixadi 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 exempts substance use disorder patients from the work requirements. On that brief update, I'll hand back to Fredrik.
Okay, thank you Richard. Then over to a pipeline update starting with CAM2029, which is under development for treatment of acromegaly, gastroenteropancreatic neuroendocrine tumors, and polycystic liver disease. In the quarter, we were pleased to receive a positive opinion from the CHMP recommending approval of Oxyceisa, the EU trade name for CAM2029 in acromegaly. This was followed by a final approval by the European Commission on June 30th 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 Sandostatin and Somatuline and provides a really good starting point for establishing Oxyceisa as a first-line treatment of acromegaly.
In preparation for the launch in the first EU markets, estimated to be 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 AcroNova 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. Adding to the existing evidence base for CAM2029, in the quarter we received new compelling results from an extension study of AcroNova 2 from a subset of patients that were treated for an additional 12 months with CAM2029 to a total of two years.
These patients constituted two different groups: those who continued treatment with CAM2029 directly after finishing the AcroNova 2 main trial, illustrated on the left side, and patients who were reinvited to treatment with CAM2029 after an intermediate period back on treatment with 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 1 time upper limit of normal after switching from standard care to treatment with CAM2029 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 CAM2029, and then this was of course reversed going the other way.
The improvement that we see in the response rate may very well be related to the high octreotide exposure provided by CAM2029, which is of course potential and very interesting for other trials including the Sorrento study. As in previous studies, treatment with CAM2029 also resulted in improvements in acromegaly symptoms and treatment satisfaction, further emphasizing the potential benefits of the CAM2029 treatment for patients with acromegaly. 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. CAM2029 has orphan drug designation for isolated autosomal dominant polycystic liver disease in the U.S.
and Europe, and 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 3-arm study of 2 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 CAM2029 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 1 and safety, of course. 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 CAM2029-treated patients. The relative change between CAM2029 and placebo groups increased, and that's on the right-hand side, to a mean of -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. 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 Camurus' own developed PLDS questionnaire and other patient-reported outcome measures. We also saw a robust decrease of plasma IGF-1 levels with CAM2029 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 core phase. In summary, for CAM2029, significant progress was made during the quarter. I n acromegaly, t he EU approval of Oxyceisa was of course the highlight.
The corresponding application in the U.S. is ready for resubmission f ollowing 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 GEP-NET, the Sorrento Phase III trial has progressed according to plan, and the randomized part of the trial is expected to be completed in the early part of 2026 as communicated earlier. As we already have alluded to in PLD, we are preparing for an end of Phase II meeting with the FDA to discuss the design of a registration Phase III program of CAM2029 in polycystic liver disease. Alongside the advances in the CAM2029 programs, we have progressed the Phase I study of our once-monthly semaglutide formulation CAM2056 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 strategically important collaboration as noted before, a licensing agreement with Eli Lilly for the development of and commercialization of long-acting incretins in the cardiometabolic space, and 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 agonist, 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. In return for the agreement, Camurus 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. Camurus had an excellent quarter with record high revenues. We received EU approval for our second commercial product Oxyceisa in a new therapeutic area, got positive results from both the Positano and the AcroNova extension studies, and signed a strategically important license agreement with Lilly. I would like to thank you all for listening and then 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 key five on your telephone keypad. The first question is from Christopher Uhde 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 Brixadi and I guess it's in sort of parts because I'm really just trying to understand the dynamics of the market there. 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 in particular about why your market share of injectable buprenorphine has plateaued and what steps can be taken to gain gross share? You mentioned in the report that the oral buprenorphine decline came as a result of injectables growth. My question is, did the oral buprenorphine decline come as a result of injectables growth only, or were there other meaningful factors at play? Thanks. That's the first one.
Thank you, Christopher. Overall in the U.S., I think the most important conclusion from this report is that growth is back in the U.S. in terms of Brixadi, and it was a very strong quarter we had. We were not sure how quickly this would return, but we are pleased with the growth that we have seen in the second quarter. The reason for this, I think, 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. 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. 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. I think that's the response I have. Any further comments from the team here? Does that answer your questions, Christopher?
Yeah, that's great. If I could ask a quick one on Oxyceisa for acromegaly in Europe, how should we think about the early ramp up?
We will follow a country by country approach, similar to what we have done with Buvidal. We see a large interest in the market, but obviously this is a smaller indication. The interest is very large. It will be a country by country approach.
Okay, great. What are potential conferences you're considering to submit an abstract to ? 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, E-A-S-L, and I think it will be in May next year. The abstracts are due, I think, early January. 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 ADPKD patients, the ADPKD-associated PLD, and the ADPLD 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. You had two dose levels, right?
Yes. W e 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. Overall, it seemed to be a similar response between the two dose groups.
Got it. My last question would be on just the incretins. What was your spreadsheet CTA time, if I may phrase it that way, for semaglutide? How long ago did you expand the development work to include other incretins?
In terms of, we had a very rapid process from which was the start of our preclinical program for semaglutide and the clinical trial. I don't want to go into that. It was a quick process and I assume that you are alluding to or thinking about the next steps and so forth. I mean it's ideally it can be done quite quickly.
Okay. Should we be thinking like a year or less or more?
I don't want to give, I mean, if you're trying to, you know, use that for our partners' timelines, I think it's better to report them once they occur.
Okay, thank you so much.
Thank you.
The next question is from Suzanna Queckbörner from Svenska Handelsbanken. Please go ahead, Suzanna. Your line is open.
Hello. Thank you for taking my questions. I want to ask a few regarding Buvidal. I noted that you had 2,000 net additions of new patients in Q2. That's an average of 3,000 patients. I think seasonally Q2 is also expected to be quite strong. 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 affected in the quarter, as I said, by various factors including some stock, the distribution wholesalers and their ordering patterns. There was a short term delay in the U.K. as the committed funding by the government hasn't reached the clinics yet. We're expecting that in the next three quarters and that will accelerate from there. Yes, it was a little light, but I think we'll catch up going forward.
This is the stocking effect and delay effect. It's not something representing saturation of the market or something like that?
Correct.
Okay. As a follow up question, I wanted to ask about the Eli Lilly deal going forward. What kind of ability will you actually have to shed progress in this? Are we going to get any press releases or is the new float completely owned by Eli Lilly?
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. We are expecting to be able to report continuously on more important events, but perhaps less so.
Finally, on your guidance that you haven't changed since the beginning of the year, given the weaker Brixadi sales in Q1, and now the upfront payments of the Eli Lilly 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 Buvidal and Brixadi, or how do you expect to reach your top line guidance?
I think it's important that we have stated, and this is also the information we have received from our partner in the U.S., that we are expecting, you know, growth to continue in the third and fourth quarter. Richard just said that we are also expecting to see growth in the second half of the year for Buvidal. Both of those are, of course, key considerations when we have reviewed and updated our guidance, and they are major components of that.
Okay, thank you.
Thank you so much.
The next question is from Shan Hama from Jefferies. Please go ahead. Your line is open. He disappeared. Your line is open, Victor.
Okay. Hi. Thanks for taking my question. Yes, a quick one maybe on Buvidal. You mentioned U.K. with delayed funding. Will that be back already in Q3, or do you believe 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, the government had committed the funding for treatment in opioid pensions for this coming year. It really is just a bureaucratic slowness in that money moving from government departments into the clinic. That's why we're positive that it's going to change. We expect it to come in the next three quarters because the NHS year runs from March to April. We certainly expect to see the next two quarters this year, a pickup as that money comes in. Oh, in Germany. Germany, we're progressing. We still have the same reimbursement 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 are ongoing pilots in a number of areas. We're watching the space carefully on that and are expecting a resolution relatively quickly, hopefully.
Okay, thank you. Also, a question here on the Lilly deal. I know how much you can disclose around this, but I just wanted to get some more details around how this deal materialized. Did you speak to other parties here before this deal was done? 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. Any comment you can give on the rationale of the financial structure of this deal is 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, et cetera?
I just wanted to get some more details there, if it's possible. Thanks.
Sure. On the financials, first of all, on the financials, I can say that we focus on other things than the short term. Our financial situation is, as you see, strong. We have focused on other aspects of the transaction. That's the main reason for the milestones. When it comes to other discussions, I cannot, unfortunately, Victor, as you understand, comment on that. 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, yes, I fully understand and also had a final question. I guess the market now sees a bit more of your platform potential after the Lilly deal. I just wanted to ask a quick question of your program with your gonadotropin releasing hormone agonist with FluidCrystal technology. What's the next step here? What's the opportunity in terms of perhaps market size, unmet need, et cetera, especially in comparison with other current long-acting formulations, CAMCEVI, as you know, every six months administration will also have leuprolide in this space, et cetera. I don't think any comment here would 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, any comment? 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. We will certainly prioritize that. In short, it's not the time for those announcements today.
Okay, thank you very much.
In a structured fashion, thank you.
Shan Hama from Jefferies, please go ahead. Line is open.
Hi, thank you. Just a few from me, please. I believe, if I remember correctly, the aim was to have over 100,000 Buvidal treated patients by 2027. Obviously you'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? What is the potential for methadone switches? That's my first question.
Yeah, I think I'll leave that question to Richard.
Yeah, I think it's a good question. Our ambition still remains to 100,000 patients by the end of 2027. Clearly, we're working across the major geographies to try and address the funding and improve access to Buvidal. I think what's clear is that the benefit that Buvidal 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. We hadn't seen that with sublingual necessarily, but we've certainly seen with Buvidal that patients are interested in moving over because of the benefits that long-acting product preparations confer to patients. 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. We continue to expand into new markets as well.
I talked about Portugal. That's a big opportunity for us. The 100,000 still remains our ambition, certainly still achievable. We have some plans to try and address the hurdles that are preventing them.
Brilliant. Thank you. Was that by the end of 2027?
Yes.
Okay, great. Just on Brixadi, where do you stand in terms of long-acting injectable buprenorphine market share versus your peers?
The last time we have actually announced market share, we'll see now, you know, once our peers have reported, but we said that it was in the region of 25%. We haven't made any further developments there or talked about it. That was, I think, in the end of Q4 in the Q4 report.
Understood, thank you so much. Finally, sort of given your cash position strength and particularly on the Lilly front, 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. However, they will not be communicated until they have been settled, so to speak. We have a very active agenda ongoing.
Got it. Thank you so much. That's all for me.
The next question from Oscar Haffen Lamm from Stifel. Please go ahead. Your line is open.
Thank you for my question. My question would be, you know, how should we think in terms of forex impact for the H2? 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.
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 scenarios in our guidance. We don't see any problem. As discussed in prior earnings call, we apply hedging. We have a rolling hedging structure implemented already three years ago. That's why, from a profitability point of view, we have limited impact on FX fluctuation regarding the rates we use. When we provide guidance, we don't disclose the rates. We provide the guidance, but we provide guidance at reported rates. The scenario is the same. We work with three banks, 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 appreciation of Swedish krona, somehow we were already anticipating it and we hedged for that. The main impact has been in U.S. dollars, where we have been impacted by 11 points quarter-on-quarter. The Brixadi growth more or less at constant rate is 32%. The second one is Buvidal, where we have been impacted in Australian dollars, GBP pounds, and euro, and it is something like six points quarter-on-quarter. That's a bit of the overview.
You're very clear. Thank you. 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 III?
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 II meeting with the FDA, which we are preparing for.
Okay, thank you. Very clear. That's all for me.
The next question from Jon U. Garay Alonso from ABG Sundal Collier, please go ahead. Igor.
Hi, this is Georg Tigalonov from ABG Sundal Collier, thank you for taking my questions. I have one left. Given the recent development of Brixadi sales, could you perhaps provide some insight into when we might expect the first sales milestones from Braeburn? Does this to any extent factor into your decision not to revise the 2025 guidance? Thank you.
The information that we have provided in regards to the milestones is that there are three milestones at different sales levels, and all are, you know, 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, Jon, or is it?
No. We have not disclosed if our guidance includes milestones or not. We are working closely with Braeburn 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.
That is the amount of information that we have available at this moment. Are you okay with that, Georg?
Okay, thank you.
Thank you.
The next question from Christian Glennie from Stifel, please. Go ahead, Christian. Your line is open.
Hi guys. Thanks for taking the question. Follow up on the Stifel side, a couple, please. Just maybe around some points of data point, I guess, clarification as much as you can. If we look at prescription data for Brixadi in the U.S., it's up about 14%, 15%. You've done double or you implied sort of double, double that in terms of absolute sales. 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. First of all, as we know, the numbers that come by IQVIA and other data providers, it's a limited data set and it doesn't cover the full market, especially not specialty distributors. That may be one source of the kind of disconnect between the data provider numbers and the numbers that we provide. I should, of course, also comment on the fact that our numbers are from our partner. 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. 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 to clarify what you seem to be implying, as much as you're aware, on the CGS part of the market, the funding, the budget issues, it seems to be, you seem to be saying that has at least stabilized. Has it improved through the second quarter, do you think?
I think the effect has absolutely stabilized. Improvement is difficult to give you a view on right now. Can you give me a little bit more clarity into your question? Maybe I'm missing something.
Do you want to take more around? We know that the.
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. As much as you can read across from IQVIA on orals, it looks about flat in the second quarter. Obviously, you're referencing some claims data. Is there anything that might be different there in terms of the disconnect between those two, and are you in that same data? The implication is that LII has taken that share. Is there something else that might explain that minus 5%?
I mean, there is clearly a gain in share from Buvidal versus oral, at least in our data sets. Again, there is quite a disconnect between data providers in their coverage. I cannot say this is the data we are using. It's possible that IQVIA data or whatever you are 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 in 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 delay, so I reconnect the telco and we go forward in a second. Now we are ready to take Richard Ramanius question from Redeye. Please go ahead. Your line is open.
Good afternoon. I had two questions about your clinical development programs. Firstly, your multi-semaglutide CAM2056, will you have to do at least three studies after the Phase I before approving for an approval, and CAM2029 in PLD. Could you give us some more details about the timeline for the Phase III study?
On the first question, we have not. There are possibilities to go into a larger study very shortly after the initial, because this is really a Phase IB study. However, we haven't announced anything and we have a number of activities ongoing. To further elaborate on that, when this 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. It will be depending very much on the outcome with the regulatory authorities. 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 Uhde 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. 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?
Richard said that one of the important things is that the kind of Medicaid, the patient percentage remains, at least to our understanding, remains unchanged. That is a positive. There has been the work requirement, which to my understanding, the Big Beautiful bill kind of exempts the substance use disorder treatments population from that requirement. That is also a positive. There is another detail on that, and that is the more frequent authorizations that would be required. That is something that probably can be handled by the stakeholders involved in the treatment. Overall, I think that it looks quite positive in the context of the general political development in the U.S.
Okay, that's very helpful. Just one last one on the guidance, just kind of following on from Suzanna's question, which was, 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. That's not the case.
Okay, thank you very much.
There are no more questions from the telco at this time. 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 Jon for his contributions through these meetings over the years and it's greatly appreciated and we also welcome Anders, of course, to take his place going forward. Great to have you.
Thanks a lot.
With that said, I wish everybody a wonderful summer and speak to you in Q3 or before. Thank you.