Camurus AB (publ)

Thank you so much, Einar, and good day, everyone. Thank you for joining our first quarter earnings call. As previously, please note our forward-looking statements. So the agenda for today's call is as follows. We start with business highlights, followed by reviews of financial and commercial performance, then finish off with a short R&D update before moving over to Q&A. So as previously with me today are John Garay, our Chief Financial Officer, and Richard Jameson, Chief Commercial Officer. So overall, Canberra's had a productive and highly profitable first quarter 2025. This was driven by continuous commercial execution in Europe and Australia, strengthening our leadership position in opioid dependence treatment, Bividual sales increased to 485 million SEK, increasing 6% versus the previous year at constant exchange rate. Brixari royalties from the US increased 185% versus previous year, however, were flat versus previous quarter at CET. Notably, the overall buprenorphine OUD market in the US was down 13% during the same period. In the R&D pipeline, dosing was initiated in a phase one study of R1's monthly semaglutide. The phase three Sorrento-Positano studies of CAMP2029 in neuroendocrine tumors and polycystic liver disease progressed according to plan. And in addition, after the period, we received positive CHMP recommendation for approval of CAMP2029 in acromegaly in the EU. under the trade name Oxyisa. Financially, we had a strong first quarter with operating results growing 204% year on year to 239 million SEK. In parallel, we continued strengthening our sustainability profile, inaugurated our new headquarters in Lund and R&D laboratories. And after the period, we announced the appointment of Anders Wadsholt, as our next CFO, joining Camurus on the 1st of July, thereby ensuring a smooth transfer over from John. With that said, let's move over to the financial update.

Thanks a lot, Fredrik, and good afternoon, everyone. Camurus delivered a strong financial performance in Q1, and we would like to share now its main highlights. Camurus achieved 558 million SEK total revenue in the quarter, delivering a growth of 43% versus same period last year, with product sales of 485 million SEK, growing 33% versus prior year and 3% versus prior quarter. Swedish kronor appreciation has impacted reported figures negatively by three points versus prior quarter. Bricsaddy sales in the U.S. represented a 74 million SEG royalty income in the quarter, growing 185% versus prior year and 1% versus prior quarter at constant rate. Shredded scroller volatility has impacted negatively royalty reported figures by 12 points versus prior quarter, hence the minus 11% growth you can see in our reported numbers. Company profit before taxes was 254 million SEK, representing 45% over sales and growing 162% versus prior year. Earning per share after dilution was 3.29 Swedish kronor, equivalent to a profit after tax of 197 million SEK in the quarter. Finally, our cash position was 2.9 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% in the quarter, representing an improvement of 88 basic points versus same period prior year. The improvement was driven by three major factors. Firstly, geographical mix represented 29 basic points. Secondly, 40 basic points are driven by BRICS-ADI royalty. And thirdly, FX represented a positive impact of 19 basic points. Total OPEX reached 289 million SEC remaining flat versus same period prior year driven by following factors. Marketing and distribution investment to support market penetration in known territories. Expansion of Woobidal into new markets and US operations grew 25% to 116 million SEC. Administrative expenses aligned with corporate evolution to substantiate company development grew 158% versus same period last year to 42 million SEK. R&D investment reached 131 million SEK, 27% below same period prior year, driven by lower milestones in our ongoing clinical trials and acromegaly study ramped down. Company profit before taxes reached 254 million SEK, growing 162% versus prior year and representing 45% over sales. Company cash position at quarter end was 2.9 billion SEK. Camurus improved its cash position by 25 million SEK in the quarter, driven by following four factors. Firstly, company operations generated 246 million SEK. Secondly, working capital increased by 168 million SEK, driven by receivables growth, payables and liabilities reduction, following R&D milestones and company bonus payout. Thirdly, company invested 34 million SEK in new headquarters and technological activities. And finally, company balances translation represented a negative impact of 12 million SEK. Ascent of quarter, Camurus has no debt. All in all, Camurus closes first quarter 25 with a strong financial performance, interesting growth opportunities, and is on track to deliver 2027 vision. Having said that, I would like to pass the word to Richard. Thank you everyone for your attention.

Thank you, John. I'll start with the cameras markets and then move across to the US. So starting with cameras markets, which include Europe, Australia and the rest of the world, we continue to deliver strong performance across geographies with net sales growing 33% versus previous year and 6% versus previous quarter at constant exchange rate. At the end of the quarter, we estimate close to 63,000 patients are in treatment with Buvidal. Growth was seen across our markets, led by UK, Australia, Germany, and Nordics, as our teams continue to successfully improve access for patients through addressing funding by demonstrating the value Buvedal brings to healthcare and society, the growing awareness of innovative treatment options, and supporting informed choice for patients and those outside of treatment. Alongside this, our sales teams continue to execute on their plans to drive penetration at a clinic level. We further expanded into new markets with launches and first patients treated in both Switzerland and Luxembourg and finalized reimbursement process in Portugal and have launched at the beginning of Q2. Additionally, we received regulatory approval in Serbia and have initiated a reimbursement process and three other regulatory applications are under review. Now moving across the US, as John has already said, the royalty from Brixardi grew 185% year on year and grew 1% in the quarter at constant exchange rate with an FX headwind of minus 12 in the quarter. The U.S. Buprenorphine market was challenging as down 13% compared to the previous quarter. This is likely due to a combination of transient headwinds, including the unwinding of Medicaid continuous enrollment that was set up during COVID, ongoing budget restrictions in federal prisons limiting access of long-acting Buprenorphine, alongside the usual seasonal impact on new authorizations. Our licensee Braeburn expects Brixardi to deliver renewed growth in the coming quarters as these headwinds diminish. So on that I hand back to Fredrik.

Okay, thank you Richard. Over to a short R&D update then. And beginning with the progress with CAM 2029 across our three indications. Starting with Acromegaly and the clinical program there, we have previously completed and reported positive results from the AcroInnova1 efficacy study, as well as the core phase of the long-term safety and efficacy study AcroInnova2. During the first quarter, dosing of the last patients in the extension of AcroInnova2 was completed and results will be presented at upcoming scientific meetings and in publications. In gastroenteropancreatic neuroendocrine tumors, the Sorento study has progressed according to plan, and we expect to reach the target number of PFS events early 2026 to start reading out the primary results from the trial. Finally, in PLD, we have completed treatment in the randomized part of the Positano study and expect to present top-line results later in this quarter. To remind you, Positano is a 53-week randomized three-arm study of two doses of CAM2029 versus placebo. The study has included 71 patients with symptomatic polycystic liver disease. The primary endpoint is height-adjusted liver volume And the key secondary endpoint is patient-reported symptoms, determined and reported by PLDS questionnaire, which has been developed internally by CAMERAS based on FDA guidance and our also collaborator. In addition, there are multiple secondary endpoints assessing, for instance, cyst volumes, quality of life and safety for patients treated with CAM 2029. Based on the results of the Positano study, we will initiate discussions with the FDA and EMA about the pathway to registration of CAMP2029 in polycystic liver disease. If approved, CAMP2029 could be the first pharmacological treatment available for people living with polycystic liver disease. Moving over to the regulatory side, The registration processes for CAM 2029 in Akromegaly continue to progress in the quarter. As a consequence, we were pleased to announce a positive CHMP opinion for EU approval of CAM 2029 in Akromegaly. The email review process has progressed very smoothly, faster than we were hoping for initially, and a final market authorization decision is expected from the European Commission during June. Regarding the US registration process, we are ready to resubmit the NDA as soon as we have received comfort about the CRL resolution at the third-party manufacturer. For this purpose, we have instituted an independent audit of the manufacturer. This is scheduled to the end of this quarter. As soon as possible after that, we will resubmit the application. Ahead of potential regulatory approvals and launches of CAMP 2029, our medical team has been busy disseminating results from our clinical trials at key scientific meetings and conferences. We've got excellent response. As an example, about 600 participants attended our satellite symposium at the European Society for Endocrinology meeting in Copenhagen this previous weekend. The coming weekend, our US team will be attending ACE in Orlando. And later in July, we have the big endocrinology endo meeting coming up in the US. In parallel, we continue working with pre-launch activities in the US and Europe. including payer interactions. In the early pipeline, we advanced our clinical study of our once monthly semaglutide formulation in participants with obesity or overweight, as well as R&D activities relating to other long-acting incretin candidates. In the clinical study, all participants in the randomized part A have now been dosed with CAM2056 or weekly semaglutide comparator. And most patients in the dose escalating part B trial of the study have also been included and received at least one dose of CAM2056. Top line results from the study are expecting in the second half of the year. So with that, it's time to wrap up. I want to finish by saying that Chemers had a solid first quarter, with record high profitability from operations. Continued bivouac growth in Europe and the rest of the world. Riksari US sales held up in a challenging US OED market. And in addition, we started dosing in a phase one study of CHEM 2056. After the quarter, we received a positive CHMP opinion for Oxuisa in Acromegaly in the EU. And with this, I would like to thank you for listening. And Einar, let's move over to Q&A.

Thanks. The first question comes from the line of Susanna Queckburner from Handelsbanken. Please go ahead. Your line is open. Susanna.

Hello, Susanna Quekburner here from Handelsbanken. Hi. I'd like to ask my questions one at a time, please, starting with the Australian market. So your Australian sales have reached 187 kroner in the quarter. That's over 90% year-on-year growth and a large step up compared to Q4. Given that Australia is actually quite a mature market, I'm curious to understand whether this is a timing of order situation and maybe something that's worth quantifying from your side. Help me understand this better and how that would impact Australian sales going forward.

Well, I think I'll leave the question over to John.

Thank you very much, Frederic. Thanks a lot, Susana, for your question. To the best of my knowledge, we do not disclose the Australian cells. If I remember okay, on page 30 of our report, note 4, what we disclose is Africa, Middle East and Asia, including Oceania. And if you refer to the sentence below the table, it refers to customer. We don't disclose in which country is this customer. But what you may reassure is compared with prior year, and this is public information, last year the Australian government implemented a pharmaceutical benefit scheme starting by the second half of 23 and finalizing in the first half of 24. And we were very transparent that all the pharmaceutical providers in the country, they would have ups and downs last year in their sales to the government. So that's what happened last year. Coming back to your question about the market performance, we are very confident on our execution and the execution by our team in Australia. And we continue having a successful market share of 80%. So far, we are delivering according to our plan. Is that right, Richard? Thank you very much.

Maybe just stress that we are expecting to see continued growth over the next quarters in Australia.

Right, okay. Then just as a quick follow-up question to that, so with this extraordinary customer, is it fair to assume that they may not just supply to one geographic region?

We are not disclosing the speed of our customers by region and no one, Susana. The information public by region for competitive intelligence reasons is the one disclosing in the note form.

Susanna, are you there?

Then I'll get back in line. Thanks.

Yes.

Sorry, Victor is coming up here now. Yes. Hi, this is Victor from Nordea.

Hi, Victor.

Yes, you ready to take questions from you, Victor?

Yeah. Hi, can you hear me? Yes. Yes. Yes. Hi. Thanks for taking my questions. Yeah. Yeah. So you asked a question here on your US market. I know it's your partner responsible for that, but just any color here would be appreciated. So on Medicaid Unwind, I mean, this has been going on quite some time, also last year, and it seemed to impact your partner, Braeburn's competitor in the U.S. in Q3, Q4, et cetera, but was never mentioned from your side. But was it also impacting your growth last year, as many patients lost Medicaid for a shorter period of time when this Unwind process was ongoing? I think I start there.

I think that is highly likely. I mean, all the industry was impacted by this provision, the unwinding of the Medicaid continuous enrollment provision. However, the growth rate of anxiety was so high and actually it was not the factor that we had raised to us at that time point by from the information we received, so to speak. But obviously it became more clear in the data coming out here from the first quarter. So we believe that this effect is diminishing over the year. It's probably from the data we have looked at now, it probably was maxed out in the first quarter. And we believe it's still diminishing going forward. Our licensee has also informed us that they are expected to see renewed growth in the coming quarters. Are you hearing me?

We seem to have a short delay.

Okay, thank you. And how good visibility do your partner have here? I mean, we have April in the book. Yeah, well, I mean, we have...

We have also established visibility through our third-party providers of data. So, Viva is now supplying us with the data on these topics. So, we have a visibility here from both angles.

Yeah, thank you. I think my question was cut off a bit. I also wondered, you know, I've seen that states can continue to unwind Medicaid until June 2025, if I'm informed correctly. So as you said, was it maxed out here in Q1 and you don't expect much in Q2 to happen? And then I guess I had a second question. FX has of course moved quite a lot here versus when you put out your guidance for the full year. Do these mean that you have seen even stronger underlying growth that will offset FX headwinds, or how should we interpret your guidance with regards to foreign exchange movements? Thank you.

so so thanks a lot for your question victor when we provided our guidance in mid-february we already simulated different effects scenarios so at the moment we are working inside those those scenarios that our partners banks they provided to to us so our guidance has stated in our report at the moment is maintained Are you there, Victor?

Okay, thank you. And I just had a quick final also on polycystic liver disease. Can you give some that in LAR has had some good data, but this readout, could it be enough for any kind of approval, or should we see more? Should we need to see more in order for approval here? And maybe just a quick word on the commercial load. outlook for this indication that don't currently have any approved products, it could be helpful as well. Thank you.

Yeah, so when it comes to the registration route and we have already said that we don't expect that there will be an approvable trial for the US and for the Europe, it's also, I would say, still It's quite optimistic to believe that one phase two slash three trial will be a registrational in this indication. However, we haven't had that discussion with the European authorities yet. So the intent is to start a registration of phase three trial as soon as we can after reading out the data. And when it comes, did you ask about the market?

Okay, thank you very much. Yes, I also asked about, you know, commercial outlook. Sorry for the bad quality.

It's very hard to... Yes, we have provided... Yeah. We have provided our market estimates for the polycystic liver disease indication, and it is, what is it, in between acromegaly and the neuroendocrine tumor indication. So in our previous estimates that we have shared, it's between 3 and 400 million US dollars peak market potential estimated.

Thank you very much. I'll jump back in the queue.

The next question is from Ricard Romanius from Redeye. And I'm sorry about the delay. So when speakers are handing the word over to the analyst, there is a delay, but not on the other way.

Hello, good afternoon. I have four questions, starting with you. Have you noticed any impact of the label change for your competitors' products that was announced in February?

No, we have not seen any impact. Of course, it would be indirect impact, but we haven't seen any so far.

Okay, good. And then a question about CAM 2029 in Exomegaly. When would you expect to get the PDUFAD date of your submission and when do you think you could start selling the product? I know it's a long registration of product to get it registered on all the European markets.

There are two possibilities, theoretically. The class one resubmission route, which will be two months after resubmission. And the other is a six-month process, which would be more aligned with... If there is a requirement of re-inspection of the manufacturer, then it's more likely that it will be a six-month process. So two to six months is the answer to your question. Any other questions?

Yes, I have two financial questions. You mentioned the incremental capital investments of 0.35 billion SEC to fully deploy use operate is capitalized. And how much of that is cost, registered cost?

Sorry, sorry, Ricard. There is a lot of noise on your line. I could not understand your question. Would you mind repeating it?

Yes, the question was, you mentioned the incremental investment of approximately 0.35 billion SEC to fully deploy US operations. I wonder how much, if any, of this is capitalized. I mean, how much of it ends up on the balance sheet?

None. In our market guidance, the point 25 was not only to deploy U.S. operations, was to support the launch of Acromegaly in U.S. operations and globally as well. All of it is OPEX, Ricardo.

Okay. I also wonder about your... transaction you plan to do, do you think that's going to be a transformative large transaction where you might need to use more than just the cash on hand, or do you think it would be more of an accretional deal like a licensing deal?

Well, I think Both are possibilities at this stage. We are continuing our work on the M&A side and it could be both transformative and additive. So we haven't given any specific direction there. Both possibilities.

Okay, very good. Thank you. That were all my questions.

The next question is from Sian Hama from Jefferies. Please go ahead. Your line is open.

Hi there. Just a few from me as well. We can take them also one at a time. So firstly, could you give us perhaps a rough estimate or just some, I guess, qualitative color of how much Bricsadi sales come via the criminal justice system channel. And then if possible, how much of that is from federal prisons versus from state prisons?

Thank you, Sean. Actually, for competitive reasons, we do not provide that information from our partner. We have informed that Medicaid is the single largest payer in our mix, followed by commercial, and then we have Medicare and finally then federal. So it means that likely it's not one of the largest, it's not a large fraction in the mix, but noticeable.

Understood. Thank you so much. And then what gives, I guess, obviously this is more for Braeburn, but what gives you and your partner Braeburn sort of confidence to return to growth for Brixazi, and obviously by extension your royalties over the coming quarters? It seems like some of the headwinds, such as the budget cuts, are potentially unlikely to resolve.

Well, yes, I mean, as you said, the question is perhaps not directed to us specifically, but I would say that the medical need consistently is there and still have over two million people in need of treatment. And if you look at the development over the course of the last quarter, even though it's been very tough, it's there has been an increase in the market share for long acting injectables in this climate. And I think that gives a good position once things are easing off and these transient issues are being slowly addressed. I think we have only had really one quarter with these numbers for Bricsati. So it's been a short and process so far.

Good, thank you so much. And then just one clarification from me. So in your 2025 guide, you include a small portion of revenues from Oclays. Is this EU only or both EU and US?

so so if i remember okay uh sean in our market guidance for 25 we have not provided clarity uh if there is any amount for a place analyst yes you are assuming or place and and so on but in our guidance we have not disclosed and provided any i would say any direction about how much is your place and if it is only us and europe so i at the moment i would like to stay at that at that stage

thank you so much there are no more questions from the telco so i hand the word back to you frederick john and richard thank you i would just like to thank everybody for listening in and i look forward to meeting you after this update and hopefully also next quarter so thank you very much for joining the call and have