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Cambiar Aggressive Value ETF Stock Price: Quote, Forecast, Splits & News (CAMX)

Finance

Company Profile

New

Cambiar Aggressive Value ETF Price & Performance (CAMX)

Stock Performance

Updated Mar 18, 8:10 PM UTC

CAMX:AMEX

$30.41USD

0.24% · $0.074

Open

$30.41

High

$30.41

Low

$30.41

Market Cap

$60.11M

P/E Ratio

17.9

Volume

46.00

Year High

$31.71

Year Low

$27.46

Dividend Yield

1.28%

News & Market Insights

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Mar 15, 2025
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Energy markets are experiencing supply challenges as geopolitical tensions impact oil and natural gas production. These disruptions have led to price volatility, affecting both producers and consumers worldwide.

What's Happening

Earnings

Report Date

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Rev Estimate

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Avg 1d Change

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Report Period

Q4 2024

EPS Estimate

—

Implied Move 1d

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Transcript

7m 12s

Before starting, please note our forward looking statements. [indiscernible] So we will begin the presentation today with a short business highlights. Then review the financial performance, followed by commercial and R and D updates. CFO and Richard Jameson, Chief Commercial Officer. Camillus had a rewarding 2024 with good performances across the business. This resulted in high growth and profitability alongside In parallel, we continued the geographic expansion with the establishment of Chemours Inc. In The U. S. Importantly, we remain on track to deliver our five year vision of revenue growth from 2022 and an approximate 50% operating margin in 2027. As a reflection of the solid performance during the year, we delivered continued strong operating revenue growth. As well as you can see on the right hand side here, sustainable high profitability. Our fourth quarter results exceeded previous estimates. With Bivotal growing at double digit rate in own territories, and Brixayty finishing the first full year with strong fourth quarter. Additionally, we established a fully operational U. S. Commercial organization has prepared for the launch of Oaklase in acromegaly. We On the development side, regulatory reviews of CHEM twenty twenty nine continued in The U. S. And EU. With a temporary setback in The U. S. In the form of a complete response letter from the FDA, relating to an inspection of a third party manufacturing facility.

9m 6s

I will come back to this later in the presentation. In parallel with the regulatory reviews, our clinical studies Sorento and Positano continue to advance. And before the New Year, we initiated a new study of our once monthly semaglutide GLP-one product. On the corporate side, we delivered solid financial performance, positioning the company for further expansion and growth in 2025. With this short introduction, I'll leave the word over to John for a financial update. Thanks a lot, Frederic, and good afternoon, everyone. During the quarter, Camorus continued its development delivering a strong growth and financial performance. Now I would like to share the key financial highlights of this quarter.

9m 57s

At the end of the quarter, Camulus achieved SEK353 million total revenue delivering a growth of 48% versus same period last year, with product sales of SEK $469,000,000 growing 28% versus prior year and 11% versus prior quarter. Additionally, Brissade sales in United States represented an SEK83 million, growing 43% versus prior quarter. Looking at full year results, Camorus reached SEK1868 million total revenue representing a growth of 9% versus prior year. Excluding one time revenues in 2023 related to Bricsadia approval in The U. S. By FDA, Total revenue grew 42% versus prior year and Bricks Adi royalty represented SEK $2.00 2,000,000. During 2024, the company achieved an earnings per share after dilution of INR7.20, equivalent to profit after tax of SEK $429,000,000. And company cash position progressed positively ending at SEK2.85 billion. Moving to next slide, we can see the main components of our profit before taxes. Company gross margin reached 94% in the quarter representing an improvement of two sixty seven basis points versus same period prior year, driven by three major factors. Firstly, supply chain efficiencies driven by Bouygues' volumes scale up represented 181 basis points. Secondly, 96 basis points are driven by 10 basic points.

11m 45s

Total OpEx reached SEK357 million representing a 4% decrease versus Semperio prior year, driven by following factors. Marketing and distribution investment to support market penetration in own territories Expansion of UBITDA into new markets and U. S. Operations grew 40% to SEK157 million. Administrative expenses aligned with corporate evolution to substantiate company development, grew 48% versus same period last year, SEK 25,000,000. Pattern investment reached SEK167 million decreasing 27% versus same period of prior year driven by lower social security costs related to long term safety plans and lower study costs in our clinical trials. On a full year basis, R and D investment reached SEK684 million, equivalent to 37% of total company revenue. During the quarter, the company explored potential transaction incurring in one time expenses of SEK8 million regarding advisory fees that are reported in other operating expense lines. Company profit before taxes reached 186,000,000 growing SEK204 million versus Q4 twenty twenty three. On a full year basis, company profit before taxes reached SEK $553,000,000, which excluding one time Mastering revenue impact represents an improvement by SEK409 million, increasing 286% versus 2020 Company cash position at quarter end was SEK 2,850,000,000.00, Camillus improved its cash position by SEK 101,000,000 during the quarter, driven by following four factors: Firstly, company operations generated SEK166 million Secondly, third window of is up SEK21, twenty four program generated SEK18 million, Thirdly, working capital consumed SEK63 million and fourthly, investing activities required SEK20 million.

13m 49s

As end of quarter, Camorus has no debt. Moving now to 2025 guidance. Company has considered the following factors when providing 2025 financial guidance. Market conditions, the current macroeconomic environment, continued investments aligned with the Strategic Vision 2027 in which we imply R and D will continue approximately flat in the level of SEK0.65 billion an incremental investment of approximately SEK0.35 billion to fully deploy U. S. Operation [indiscernible] and support company growth. Social security costs regarding company long term safety programs will vary with the share evolution. And from a capital expenditure point of view, company will invest about SEK 200,000,000.0 in the next three years to develop a second manufacturer to enhance manufacturing capability and support new product launches. Camuto's full year 2025 outlook is as follows: representing a growth of 45% to 61%, profit before tax in the range of SEK0.9 billion to SEK1.2 billion, representing an increase of 63% to 117%. All in all, Camaris closes 2024 with a strong financial solid operational performance, interesting growth opportunities, and remains on track to deliver SEK4.5 billion total revenue at circa 50% operating margin by 2027. Having said that, I would like to pass the word to Richard Thank you, John.

15m 30s

So I will start with the business in Europe, Australia and The Middle East region. In the fourth quarter, the year finished strongly with boobadil sales of $4.00, which was 11% versus the previous quarter and % over the previous year.

15m 44s

For the full year sales of Bouvedel were 1,650,000,000.00, a growth of 27% versus previous year And at the end of the year, we estimate that sixty thousand patients were currently treated with boovidal. In the EU, this was led by the large European market with U. K, France, Germany and Spain. The strong performance was a result of continued execution of key programs that drive penetration and improve access to Boveda. Resulting in continued market share gain and new patient recruitment across all geographies. In Australia, Bouba Down is now established as a first line treatment. The market share of long acting buprenorphine in Australia is now estimated at thirty two percent of all patients and Bouvardel has clear leadership in this segment. This is supported by the efforts to improve capacity and access for patients, For example, with a growing number of pharmacists that are now being trained or are now administering Bouvardel, which creates space for new patients at clinics. Our market expansion continued and in the quarter, we had three new reimbursement approvals that received in Switzerland, Portugal and Luxembourg and will launch Bouvardal in early twenty twenty five in those countries. Additionally, four other regulatory applications are under review.

16m 57s

Now moving across The U. S. First reminder of The U. S. Market where there are an estimated 6,000,000 disorder, of which an estimated $2,300,000 seek treatment in a year and $1,800,000 of those are on buprenorphine. In the fourth quarter, Brooks Adi has strong growth. Net sales grew 43% versus previous quarter resulting in royalties of 80,000,000 and SEK212 million for the full year. The launch continues to outperform previous product launches in this segment.

17m 29s

Patient capture was primarily from the large summingal Bruinorphine segment, while the remainder from transfers from other long acting products and direct initiations into treatment from Brixali by Brixali. So fifteen months from the initial launch, Brixali market share has reached approximately 25% of that long acting segment. And the peak market share potential for XADI is estimated to be above $1,000,000,000 Now to support both Bouvardel and Brizzardi, the evidence based effectiveness in different treatment settings and the economic outcomes continues to grow. In the quarter, we have three important publications. First was Next in patients using high level of opioids. Secondly, a naturalistic study showed a clear preference from patients for Brixioni injection over other long acting injectables. And finally, a paper that explored healthcare professional perceptions that showed high satisfaction for long acting buprenorphine compared to both methadone and daily sublingual buprenorphine.

18m 31s

And this growing evidence base continues being shared through our wide ranging medical education programs and the leading congresses. And on that note, I'll hand back to Fredrik for an R and D update.

18m 44s

Okay. Thank you. I will start with the CAM twenty twenty nine and the developments across the three target indications, acromegaly, gastroenteropancreatic neuroendocrine tumors and polycystic liver disease, DLD. In acromegaly, the two ACTRINOVA Phase III trials have been successfully completed with positive results. The last few patients in the extension study of ACRAINOVA two will be completing treatment in May 2025, followed by data readout and results. In gastroenteropancreatic neuroendocrine tumors, treatment of patients in the randomized active controlled SORENTO trial continued to progress With generally positive experiences communicated from participant investigators and clinical staff. Based on an indication of slower than expected study, especially in this study population of which majority had advanced disease of grade two or three when included in the trial. The estimated time for reaching the target of 194 events for reading out the primary results was updated to late twenty twenty five or early twenty twenty six. In polycystic liver disease, the last patients entered into the final stages of the randomized placebo controlled Positano trial And they are now in the process of completing the core phase of the study. With primary results expected in the second quarter of this year. On the regulatory side, we look forward to an FDA or we looked forward to an FDA approval on the PDUFA date of October 21.

20m 30s

After late stage labeling discussions with the agency, Instead, we received a complete response letter from the FDA FDA, which solely related to a G GMP inspection at the third party manufacturing facility. No concerns were related to CAM twenty twenty nine's safety efficacy or chemistry manufacturing and controls The manufacturer has responded to the observation, so and is currently waiting for the FDA to share the Establishment Inspection Report following a recent OAI classification. This will be used to decide the timing of the NDA resubmission. Which tentatively is planned for the first half of this year. In the EU, our market authorization application advanced according to plan and we expect the CHMP opinion around the mid year twenty twenty five. Followed by decision by the European Commission. On the medical side, efforts have been focused on medical affairs and disseminating results and data from our ACRINOVA Phase three studies. The main result of the ACRINOVA-one trial were published in Journal of Clinical Endocrinology and Metabolism in October and multiple meeting abstracts and new manuscripts have recently been completed and being submitted. Our medical and MSL teams have been very active informing about Camp twenty twenty nine. As well as cameras more generally to the broad acromegaly community and planning for several important events in 2025.

22m 15s

Cameras will be present at key scientific conferences and meetings in 2025 with presentations and symposia. As shown in this slide here. We We are experiencing a large interest in learning more about the product. And doing everything we can to make it available to patients as soon as possible. On the commercial side, continue to preparing for the launches in The U. S. As well as in select countries in the EU. The opportunity for CAMTRX-twenty nine is considerable. With potential peak sales across indications and geographies estimated to above US2 billion dollars annually. [indiscernible] In the early development pipeline, we advanced a number of different programs for long acting incretins, for instance, including a month three semaglutide formulation. A clinical trial application was approved in the fourth quarter and the first patients were enrolled before the end of the year. The study is now up and running, evaluating pharmacokinetics pharmacodynamics, including weight loss, and safety of KAM-two thousand and fifty six versus current commercially available weekly semaglutide in participants with overweight or obesity, are otherwise healthy. In the first part of this study, we are comparing two dosing schedules of KAM-two thousand and fifty six against the dose titration to label schedule, which is Following this, different escalation regimes will be explored And aside from the approved indication of type two diabetes and weight management, I'm sure you have learned that GLP one agonists like semaglutide may also have potential in inflammation neuropsychiatry and of keen interest to Camurus, for the potential treatment of substance use disorder.

24m 22s

Before wrapping up, I can also mention that we have finalized the setting up of our new headquarters in Lund where we're currently sitting. And we have built here a state of the art lab tailored to our different needs from early to late stage development. And this will, of course, be used there to support our plan as planned business expansion during the coming years. Based on a very successful 2024, we have laid the foundation for 2025 where we expect to see increased pivotal penetration acceleration of Bixari sales in The U. S, obtain approvals for CAM-twenty twenty nine in acromegaly deliver clinical results for CAM-twenty twenty nine in polycystic liver disease and also for the new program, CAM-two 56. In addition, we plan to diversify our business through business development activities, and the overall contributing to a positive financial outlook for 2025 which we have shared earlier today and in this presentation by John. Regarding the 2027 vision, we continue progress [indiscernible] U. S. Commercialization, pipeline progress and operating margin. So with this, as a final note, I hand over the call to our operator for Q and A. Thanks. And our first question comes from the line of Victor Zombarschonnuria.

26m

Please go ahead.

26m 5s

Yes, hi. Thanks for taking my questions. So I had one on your guidance.

26m 11s

You gave quite much color on the cost side, but I just wanted to give some get some more detail on total revenue guide. So looking at Bouvedil and the specific markets that you see ex [indiscernible] with reimbursement for long acting. So just wonder if there's any update here or in other key geographies. Also on polycystic liver disease for CHEMPT 2029, it looks quite At the risk study, given the data that we have seen in Saundostat in LARP. But I just wondered what the next steps would be if the study would read out well here in Q1. Could that be registrational or do you need a Phase three and how would that look like in terms of size control arm, etcetera? And just finally, I just wondered also around your M and A strategy. You're being quite forward that you look for M and A opportunities. So any comment if that is still the case? And what kind of assets you think could fit within your company at this stage?

27m 20s

Thank you, Victor. I mean, on the first question, I think we continue to see a lot of the drive in the large European countries, as Richard said, earlier. So that's and that includes, of course, Germany, The U. K. And but also more increasingly we see progress in Spain and also France and other countries So that's I think our focus area from a geographical [indiscernible] When it comes to the politic liberties, of course, that is a very interesting study for us, and this is an [indiscernible] So I think you should regard this as a as we have said, a Phase twothree study in The U. S, we do not believe it will suffer with one study. There is a potential In Europe, but our idea is to based on the data from the Phase two trial from Positano, we should formulate the Phase three trial, which we are currently planning. And we cannot say anything about the details here. We have been working on it for quite some time now and turning the design and also the timelines for the study. And I think we have a really good start point here, but we need the data before we can finalize this and come up with the the powering of the trial and so forth.

28m 48s

But so far, we have done a lot of work and think overall looks interesting. So any follow-up questions on that, Victor, before we move on?

29m 1s

Yes, sorry. Yes. I mean, the M and A strategy remains as previously communicated, we are targeting commercial assets or pre commercial assets and which are synergistic to our Current pipeline or commercial organizations in the different territories where we operate. Victor, any?

29m 29s

Thank you. I jump back into the queue. Thank you. Thank you.

29m 38s

The next question is from Christopher Ude from SEB. Please go ahead. Your line is open.

29m 46s

Hi there, Chris Ruiutte from SEB. Thanks for taking my questions. I guess the first one is on the regulatory situation. Just to if there's any more clarity you could possibly give into so in insight into the reasons for the OAI classification, And is the establishment inspection report all that you need to be able to refile or What else might be necessary? And what if they say there are still deficiencies, what happens Yes, that's a very good question. I mean, overall, just to go back, we were expecting to get the classic much earlier. So in mid December and so forth, it's been [indiscernible] [indiscernible] It's an interesting dynamic right now at the AGS However, I think we have a clear we know, of course, what the 483s are or our manufacturer does, and they were quite satisfied with the state of those being addressed. We are not completely clear on the review history and that's why we need the EIR because we need to get clarity on whether or not there are any of the questions that are outstanding we suppose so. And if so, what the actions we believe are necessary? I think that having studied the 483s, there is nothing that seems to be from a time perspective very extensive in mitigate So I think that we are in a good shape there.

31m 39s

But we simply need the EIR to be able to better clarify whether or not we have resolved everything or if there is anything left to address by the manufacturer. On the positive note, we don't have anything, of course, with regards to the product. The product had we had no objections and no really no comments we were ready with labeling. So we should be able to move very quickly in terms of refiling.

32m 13s

Okay.

32m 14s

And then if I could ask another question around the guidance [indiscernible] I guess in light of this, fair to assume that you're assuming an immaterial contribution from Oakley's in 2025? And then how about Brixati because last year you had sort of indirectly that the guide from your partner was extremely conservative. We try to back that out for this year, what are you expecting for Bouvedil growth in 2025?

32m 49s

No, I think that I mean, starting with the first question, you can regard Oakley's to be quite immaterial in terms of its contribution. When it comes to I'm not really sure about the the comment you made there regarding the partner, but I think that overall, they probably have quite realistic views. I cannot comment their views and therefore I don't want to to split the two components. So I think that you can regard a majority or a very large part of our guidance to be constituted in terms of revenue. Of the two Bivotal and Brixali, but we are not providing them separately at this point.

33m 39s

Fair enough. In terms of I mean you had 4,000 patients this last quarter, is that the new floor?

33m 49s

We don't have a floor. I mean, we have a target and we are tracking towards the target, which is the 100,000 patients in 2027. We don't have a clue. I think it will vary by quarter. So we are not foreseeing that we will have a a constant or have a floor. It will be varying by quarter as we have seen previously. And I think that's yes, But our target remains If I could just ask a couple more questions around the specific markets and I apologize, I had trouble hearing the answer on the remuneration in Germany. But let's say, starting with that, and so the reform, what factors will determine the timing of that? And who or which body decides? And do you have any insight into Yes, the reasons around that timing?

34m 49s

We know the process but we have because we are a commercial company, we have to have a completely hands off approach here. So we are just following this from the sidelines. We understand that the reason among the different parties that are involved, which is the kind of insurance providers, it is the of course the medical community as well as the political dimension There's what we have understood is that there is a consensus that they need to change the current remuneration basis And we think that would be very good for in terms of providing German patients with a much better treatment option. And better treatment options. We We understand from the latest updates that there is still expectations that this will be finalized in 2025. However, all of these processes are externally driven, so that but I think there is positive view on that and positive development Got it. And then I guess So if we talk about England, France, Germany and Spain, which is performing relatively best versus your expectation as started 2024 and which the worst and what gating events in those markets might be required remuneration aside to occur in order to deliver on your guidance?

36m 28s

Christopher, I don't think I mean, I think what in terms of performance, I think we have seen various performances across markets. So we're pleased with all of these markets that I mentioned and actually actually, I mean, we're seeing consistent growth There might be one or two markets that are having a slower pace this quarter, but overall very good performances So we are pleased pleased with that, and we are also pleased with the fact that we are now able to go in and launch the products in three more countries and we have processes ongoing in other countries as well. So we look forward to the market expansion possibility that has come up now both in Portugal and Switzerland. I mean Luxembourg is a very small country, but still they have 1,000 patients there approximately. So that's a very important part. And we will that market expansion process will continue here going forward. But I can't comment on specific countries. Thank you so much.

37m 38s

Next question is from Oscar Hafen Lam from Brian Garnier. Please go ahead.

37m 46s

Hi, team. Alto Hu from BG. Thank you for taking my question. So on Bouvedel, I was wondering if you could provide some granularity on what percent market share you have in major European markets? And if you believe that the uptick in patients added on treatments this quarter will be maintained in the coming year, taking into account the new markets that are to be included? And then my second question would be on the OVESTIG trial. And more precisely, after how many weeks on treatment will you measure the weight loss? And then as a follow-up on that, what would be your estimated threshold for efficacy that would convince you to push the program forward? Thank you.

38m 25s

Yes.

38m 25s

Thank you. I mean, when it comes to the European markets, I think they vary from very high percentages to lower, but maybe Richard, you can give a comment on on the broad So we shared Australia obviously before and that one's there. And as Frederic said, there's a range sometimes it depends [indiscernible] but we're making advances in the methadone So yes, I mean, there's a range from up to 30% in some markets and in in high single digits in others.

39m 5s

I think generally speaking, we can say that in the larger countries, we are around the low double digit range or high single digit range, whereas in the Nordic markets, for instance, we are up to 3035%, even up to 60%, 70% in as we have said before.

39m 27s

The Oscar's original, just to check one aspect, The answer relates to general market shares. Your question was specific to prisons, or to general market shares? The general market shares, yes.

39m 40s

Okay. Thank you.

39m 42s

And then the second one was the VIP one failure.

39m 46s

Yes. So in terms of the GLP-one study, we are conducting that based on toxicology work that we had done before. So it's currently it's for the CAMPA twenty twenty nine, the CAM 2,056 groups, it's twelve week period that we are studying. And of course, that includes any dose titration that you might be expecting.

40m 16s

In terms of the weight loss thresholds, we have not this is a study looking at pharmacokinetics tolerability and weight loss. So it's of course not one isolated topic we are looking at. We are looking at the complete holistic outcomes of the study. So I wouldn't comment on the exact threshold because still an early study. But certainly, we're expecting to see data that will point us in the direction and that we will be able to use for our forthcoming largest trials So I'm not concerned about that at all. I think we will have we have we will be able to read out the results and we have a study population of overweight and obese patients. So we will see we'll get a good picture of of the efficacy also on that note.

41m 22s

Okay, super helpful. Thank you. And maybe just one additional question.

41m 26s

Brexit in The U. S, since we're on topic of the prison system, I mean, considering the large portion of patients that are in the prison system, there would be eligible treatments. I was wondering if that this stage you're already able to give a percentage of patients currently on study that are coming from the system and how you view this segment moving forward this 2025 and onwards?

41m 49s

I can say that the opportunity is, of course, very significant. We're talking about a large number of patients. It varies by the states because I mean in some states, there is established treatment system in place. Whereas other states do not have it. So and that's very much geographically dependent But overall, the opportunity consists is very large. And obviously, Brikside has only been in the market just over a year. So this opportunity is I said, largely untouched in terms of penetration by Brixari. As you might imagine, Yes, it makes sense. That's all from me for now.

42m 45s

Thank you for taking my questions. Next question is from Matthias Hegloom from Handelsbanken.

42m 56s

You so much. Matthias Baumensteinen. Two questions, please. So So regarding the twenty twenty seven targets of DKK 4,500,000,000.0, in revenues. So historically DKK 3,000,000,000 was expected to be derived from Vuvudal Brixol and EUR 1,500,000,000.0 from CHEM twenty nine. With the CRL for acromegalyptide, perhaps more importantly in light of the market size for Geppnet the longer true time of events in Sorrento with submission, as I understand it, targeted for second half twenty six.

43m 27s

I'm curious to hear if you still expect DKK 1,500,000,000.0 contribution from CAM twenty twenty nine by 2027? Or is it fair to say that you perhaps expect a larger contribution from Bouygues Iberia we saw today compared to those initial projections back in 2022 at R and D Day. And then I have a follow-up.

43m 46s

Yes. So I'm not completely sure of your starting point here because as the R and D date, we talked about I think you're referring mainly to the contribution from Bivotal there in your initial number. But so and then the rest was a mixture So no, we don't see obviously, I mean, the acromegaly indication was and remains a small but important indication for us in terms of the CAM twenty twenty nine franchise, But and we still have a component coming in from CAM twenty twenty nine into our 2027 estimates. I don't think we have commented on the size of that, John, have we? [indiscernible] We remain as we say, we remain on track to reach [indiscernible] And that's a mix of the different the different products I referred to, but of course, the largest contribution comes from Brixidea and Bivotal. No discussion about that.

45m 5s

Okay. There's a slide saying Boveda bond penetration, SEK 3,000,000,000 at late stage product candidates $1,500,000,000 So maybe the $1,500,000,000 included Yes, exactly.

45m 16s

That's completely Yes.

45m 20s

That's correct. Because I recall another peak sales potential of buvodal in euros, but maybe historically provided correct me if I'm wrong, is I thought it was €170,000,000 or something like that. [indiscernible] I don't know where that number comes from. But anyway, Okay. All right. The target is reconfirmed no matter what. Okay. And then secondly, looking at the FDA Orange book, there are eight patents [indiscernible] to July 2022. So once CAM-twenty twenty nine is approved, are there patents beyond July 2032 that we should expect to be listed in the Orange Book?

46m 9s

For that product? Or are timelines broadly the same? I know we have received orphan drug designation for P and L from the FDA, but I'm not aware of such protection for GAP net, for instance, in The U. S. Market. So any clarification for MIB would be helpful.

46m 24s

Absolutely. So I mean, in terms of CAM 2029, we we have IP covering at least up to twenty and thirty seven. So it's I mean, there is different IP to that that covers Bivron, of course. And potentially for longer time periods over time. So we do have a number of filings that extend beyond the pivotal timeframe.

46m 57s

That's very helpful. Thank you so much. That's all for me.

46m 59s

Thank you, Mathias.

47m

Thank you.

47m 2s

The next question is from Victor Sombre from Nordea.

47m 5s

Please go ahead, Victor. [indiscernible] please go ahead.

47m 13s

Yes, sorry, I was on mute.

47m 15s

Yes, I just want to had a follow-up on the SORENTO trial also. It seems like you have twice monthly dosing in that trial. Is that a way to boost your arm versus the control arm that's given once monthly, do you expect higher bioavailability of the active compound? And could that, so to speak, there is the readout of this trial since it seems that retrospectively it is the higher bioavailability and its correlation to progression free survival that seem to drive your optimism around this trial? Any comment here would be helpful. Thank you. Yes, it's correct. I mean, the higher bioavailability is definitely consistent also for in the net indication. So in fact, the AUC, the area on the curve, the total exposure of the the treatment period is roughly about seven times higher for, CHAMP-twenty twenty nine at the dosages given in the net trial compared to the reference product And then I have to, of course, refer to the octatype product because in the trial you have both the octratide and the landreotide products So but here I'm referring to the octratide.

48m 36s

What's that, Thomas? With regards to land [indiscernible] any difference there you expect from the smaller trials that's been done are they quite similar in your opinion?

48m 52s

I mean, if you ask the clinical community, they will tell you that they are quite similar. There are some studies, they are all small, They are indicating in some cases that the octreotide arm provides better control and in some cases actually the opposite. So I think we are trying to rely on the basic material that we have internally. But there is there is no good comparative data for Landrytide or Octrotide, I would say, not in a large randomized prospective trial.

49m 35s

Okay. That's very helpful. Thank you.

49m 37s

Thank you.

49m 38s

The next question is from Patrick Ling from DNB Markets. Please go ahead, Patrick.

49m 45s

Thank you. Two short [indiscernible] about commercial and pre commercial assets that you're looking at.

49m 56s

Could you elaborate a little bit on how pre commercial you're actually looking? Are we talking late stage Phase three or maybe Phase two trials?

50m 7s

I mean, basically, late stage is is our target. However, if there are Certain reasons for looking at both the technology we are possessing, so to speak, and also our kind of key interests we could in some cases, also look at Phase II assets. So we are not bound by any, but our clear preference and focus is on commercial stage or late stage. I think that's that's my answer, our answer.

50m 49s

Okay, good. And then how far from where you are today on sort of the different indications would you be willing to to look at assets Well, we are looking at this from a scientific and commercial standpoint. Basically, we can operate within rare disease but our preference is for endocrinology assets, some niche oncology we have talked about and CNS. That's The Topics That We Have Most Interest In. But Naturally, You Have To Look Broadly To Find The Most Interesting Targets Okay, Great. Then My Last Question Is Really About Your New Manufacturing Facility. That You're Going To Invest In. If You Could Elaborate A Little Bit On Is It Europe? Is it U. S? Is it for existing products or new products? Can you give us some color on [indiscernible] capital raise, we mentioned that also in our use of proceeds. But I would like to say that our focus is on building out our capacity and especially then thinking about what is happening, we are targeting to build out The U. S. Manufacturing capacity. So that's and create that we are not manufacturing ourselves, but that's one of the main aims. So that is the process that we have had ongoing and a focus we have had ongoing for the past at least twelve months or so.

52m 48s

To give us flexibility. And we also have new programs entering clinical phase and those, of course, also need clinical manufacturing resources. So that's the target.

53m 4s

Okay, great. Good. Thank you. That's all for me. Next question is from Dana Schutte from Pariato Securities.

53m 13s

Please go ahead, Dan. Thank you for taking my questions. I think Mos has been answered. Just one question on CAM 2,056.

53m 25s

How the enrollment has been going? If that is According to your expectations and if you're seeing any competition with competitors? And if so, do you see any I mean, competition for patients? And if so, do you see any promising competitors aiming also for monthly or longer depots? Thank you.

53m 49s

Well, I mean, essentially, this is a Phase one trial, although we have then characteristics of overweight and obesity as included, but they are otherwise healthy volunteers I think we have had no problem in terms of [indiscernible] So that's [indiscernible] And of course, it's the first study. So we are exploring looking at the competitive side I mean, obviously, there are so many programs going on in this space of various nature and so forth. So So I'm certainly aware of competitors in different ways or forms and shapes. But in terms of month's monthly dosing, In the clinical setting, there is very little [indiscernible] I mean, Amgen has a program that you perhaps But that's a different approach And there has also been an announcement regarding Ascendis But I think that's the earlier stage.

55m 13s

Okay. Thank you very much. [indiscernible] The next question is from Erik Holcord from Carnegie. Please go ahead, Erik.

55m 25s

Yes, hi. I have a question [indiscernible] Average price how that has changed?

55m 36s

Over the course of 2024 and what you see in terms of pricing five in your major geographies. Is there any price cuts in certain markets that you have baked into the guidance?

55m 53s

No, the pricing is flat has been flat for the last couple of years and we predict it remaining so There are no more questions at this time. So I hand the word back to you, Federigan and Rich for some closing comments.

56m 15s

Yes. Thank you, everybody, for a very good Q and A session. I think it's been a very good year for us I'm happy that we have a lot of questions coming up from it. So John, do you have anything last comments, Richard? Thank you, everyone. I'm looking forward Q1 next year.

56m 35s

Yes. We have Q1 coming up, but in May. So thank you, everybody, and have a great afternoon. Before starting, please note our forward looking statements. [indiscernible] So we will begin the presentation today with a short business highlights. Then review the financial performance, followed by commercial and R and D updates. Of course then Q and A. As previous I'm joined in the call by John Gerai, CFO and Richard Jameson, Chief Commercial Officer. Camaros had a rewarding 2024 with good performances across the business. This resulted in high growth and profitability, alongside advances of key pipeline programs, In parallel, we continued the geographic expansion with the establishment of Camillus Inc. In The U. S. Importantly, we remain on track to deliver our five year vision of fivefold revenue growth from 2022 and an approximate 50% operating margin in 2027. As a reflection of the solid performance during the year, we delivered continued strong operating revenue growth. As well as you can see on the right hand side here, sustainable high profitability. Our fourth quarter results exceeded previous estimates. With Bivotal growing at double digit rate in own territories, and Brixaidi finishing the first full year with strong fourth quarter.

1h 11m 26s

Additionally, we established a fully operational U. S. Commercial organization has prepared for the launch of Oclays In Accromegaly. We On the development side, regulatory reviews of CHEM-twenty twenty nine continued in The U. S. And EU. With a temporary setback in The U. S. In the form of a complete response letter from the FDA, relating to an inspection of a third party manufacturing facility. I will come back to this later in the presentation. In parallel with the regulatory reviews, our clinical studies Sorento and Positano continue to advance. And before the New Year, we initiated a new clinical study of our once monthly semaglutide GLP-one product. On the corporate side, we delivered solid financial performance, positioning the company for further expansion and growth in 2025. With this short introduction, I'll leave the word over to John for a financial update. Thanks a lot, Frederic, and good afternoon, everyone. During the quarter, Camorus continued its development delivering a strong growth and financial performance. Now I would like to share the key financial highlights of this quarter. At the end of the quarter, Camulus achieved SEK353 million total revenue delivering a growth of 48% versus same period last year, with product sales of SEK $469,000,000 growing 28% versus prior year and 11% versus prior quarter.

1h 13m 5s

Additionally, Brissade sales in United States represented an SEK83 million, growing 43% versus prior quarter. Looking at full year results, Camorus reached SEK1868 million total revenue representing a growth of 9% versus prior year. Excluding one time revenues in 2023 related to SABI approval in The U. S. By FDA, Total revenue grew 42% versus prior year and Brixhaven royalty represented SEK $212,000,000. During 2024, the company achieved an earnings per share of 30 equivalent to profit after tax of SEK $429,000,000. And company cash position progressed positively ending at SEK2.85 billion. Moving to next slide, we can see the main components of our profit before taxes. Company gross margin reached 94% in the quarter representing an improvement of two sixty seven basis points versus same period prior year, driven by three major factors. Firstly, supply chain efficiencies driven by goodwill volumes scale up represented 181 basis points. Secondly, 96 basis points are driven by Bricksadia royalty. And thirdly, FX represented a negative impact of 10 basic points. Total OpEx reached SEK357 million representing a 4% decrease versus same period prior year, driven by following factors. Marketing and distribution investment to support market penetration in own territories Expansion of UBITDA into new markets and U. S. Operations grew 40% to SEK157 million.

1h 14m 55s

Administrative expenses aligned with core percent versus same period last year, SEK 25,000,000. Adon the investment reached SEK167 million decreasing 27% versus same period of prior year driven by lower social security costs related to long term MESFD plans and lower study costs in our clinical trials. On a full year basis, R and D investment reached SEK684 million, equivalent to 37% of total company revenue. During the quarter, the company explored a potential transaction incurring in one time expenses of SEK8 million regarding advisory fees that are reported in other operating expense lines. Company profit before taxes reached 186,000,000 growing SEK204 million versus Q4 twenty twenty three. On a full year basis, company profit before taxes reached SEK $553,000,000, which excluding one time milestone revenue impact represents an improvement by SEK609 million, increasing 286% versus 2023. Company cash position at quarter end was SEK 2,850,000,000.00, Camillus improved its cash position by SEK 101,000,000 during the quarter, driven by following four factors: Firstly, company operations generated SEK166 million Secondly, third window of its of SEK21, twenty four program generated SEK 18,000,000, Thirdly, working capital consumed SEK63 million And fourthly, investing activities required SEK20 million. Ascent of quarter, Camorus has no debt.

1h 16m 41s

Moving now to 2025 guidance. Company has considered the following factors when providing 2025 financial guidance. Market conditions, the current macroeconomic environment, continued investments aligned with the Strategic Vision 2027, in which we imply R and D will continue approximately flat in the level of SEK0.65 billion, an incremental investment of approximately SEK0.35 billion to fully deploy U. S. Operation [indiscernible] and support company growth. Social security costs regarding company long term safety programs will vary with the share evolution. And from a capital expenditure point of view, company will invest about SEK 200,000,000.0 in the next two years to develop a second manufacturer to enhance manufacturing capabilities as support new product launches. Camuto's full year 2025 outlook is as follows: Total revenues in the range of SEK2.7 billion to SEK3 billion, representing a growth of 45% to 61% profit before tax in the range of SEK0.9 billion to SEK1.2 billion, representing an increase of 63% to 117%. All in all, Camaris closes 2024 with a strong financial position, solid operational performance interesting growth opportunities, remains on track to deliver 4,500,000,000.0 total revenue at circa 50% operating margin by 2027. Having said that, I would like to pass the word to Richard Thank you, everyone, for your attention.

1h 18m 17s

Thank you, John. So I will start with the business in Europe, Australia and The Middle East region.

1h 18m 22s

In the fourth quarter, the year finished strongly with Bouvardar sales of SEK269 million, which was 11% versus the previous quarter and 28% over the previous year. For the full year sales of Bouvedel were 1,650,000,000.00, a growth of 27% versus previous year And at the end of the year, we estimate sixty thousand patients were currently being treated with buvedal. In the EU, this was led by the large European market with U. K, France, Germany and Spain. The strong performance was a result of continued execution of key programs that drive penetration and improve access to Boveda. Resulting in continued market share gain and new patient recruitment across all geographies. In Australia, Bouvardown is now established as a first line treatment. The market share of long acting buprenorphine Australia is now estimated at thirty two percent of all patients, and Bouvardel has clear leadership in this segment. This is supported by the efforts to improve capacity and access for patients. For example, with a growing number of pharmacists that now have been trained or are now administering Bouvardel, which creates space for new patients at clinics. Our market expansion continued In the quarter, we had three new reimbursement approvals, that received in Switzerland, Portugal and Luxembourg and will launch Bouvardal in early twenty twenty five in those countries.

1h 19m 40s

Additionally, four other regulatory applications are under review. Now moving across The U. S. First a reminder of The U. S. Market where there are an estimated 6,000,000 to 7,000,000 people opioid use disorder, of which an estimated two point three million seek treatment in a year and one point eight million of those are on brupinorphine. In the fourth quarter, Brooks Adi has strong growth. Net sales grew 43% versus previous quarter, resulting in royalties of 83,000,000 and SEK $212,000,000 for the full year. The launch continues to outperform previous product launches this segment. Patient capture was primarily from the large Somalignant Bruinorphine while the remainder from transfers from other long acting products and direct initiations into treatment from Brixali by Brixali. So fifteen months from the initial launch, Brixallie market share has reached approximately 25% of that long acting segment. And the peak market share potential for XADI is estimated to be above $1,000,000,000 Now to support both BUBERDAL and Brizardi, the evidence base for effectiveness in different treatment settings and the economic outcomes continues to grow. In the quarter, we have three important publication. First was an exploration of treatment outcome by quantitative urine measures that shows emphasized treatment effect in patients using high level of opioids, Secondly, a naturalistic study showed a clear preference from patients for Brixardin injection over other long acting injectables.

1h 21m 9s

And finally, a paper that explored healthcare professional perceptions that showed high satisfaction for long acting bupropionorphine compared to both methadone and daily sublingual buprenorphine.

1h 21m 19s

1h 21m 32s

Okay. Thank you. I will start with CAM twenty twenty nine and the developments across the three target indications. Acromegaly, gastroenteropancreatic neuroendocrine tumors and polycystic liver disease DLD In acromegaly, the two ACTRINOVA Phase III trials have been successfully completed with positive results. The last few patients in the extension study of ACRINOVA two will be completing treatment in May 2025. Followed by data readout and results. In gastroenteropancreatic neuroendocrine tumors, treatment of patients in the randomized active controlled SIRENTO trial continued to progress. Generally positive experiences communicated from participant investigators and clinical staff. Based on an indication of slower than expected rate of tumor progression in the study, especially in this study population of which majority had advanced disease of grade two or three when included in the trial. The estimated time for reaching the target of 01/2025 or early twenty twenty six. In polycystic liver disease, the last patients entered into the final stages of the randomized placebo controlled BOSITAMA trial And they are now in the process of completing the core phase of the study. With primary results expected in the second quarter of this year. On the regulatory side, we look forward to an FDA or we looked forward to an FDA approval on the PDUFA date of October 21.

1h 23m 19s

After late stage labeling discussions with the agency, Instead, we received a complete response letter from the FDA, which [indiscernible] GMP inspection at the third party manufacturing facility. No concerns were related to CAM twenty twenty nine's safety, efficacy or chemistry manufacturing and controls The manufacturer has responded to the observation. So and is currently waiting for the FDA to share the Establishment Inspection Report following a recent OAI classification. Of the NDA resubmission. Which tentatively is planned for the first half of this year. In the EU, our market authorization application advanced according to plan and we expect CHMP opinion around the mid year twenty twenty five, followed by decision by the European Commission. On the medical side, efforts have been focused on medical affairs and disseminating results and data from our ACRINOVA Phase three studies. The main result of the ACRINOVA-one trial were published in Journal of Clinical Endocrinology and Metabolism in October and multiple meeting abstracts and new manuscripts have recently been completed and being submitted. Our medical and MSL teams have been very as well as Camurus more generally to the broader acromegaly community and planning for several important events in 2025. Cameras will be present at key scientific conferences and meetings in 2025 with presentations and symposia as shown in this slide here.

1h 25m 13s

We We are experiencing a large interest in learning more about the product and doing everything we can to make it available to patients as soon as possible. On the commercial side, continue to preparing for the launches in The U. S. As well as in select countries in the EU. The opportunity for CAM2X-twenty nine is considerable. With potential peak sales across indications and geographies estimated to above US2 billion dollars annually. In the early development pipeline, we advanced a number of different programs for long acting incretins, for instance, including a month three semaglutide formulation. A clinical trial application was approved in the fourth quarter and the first patients were enrolled before the end of the year.

1h 26m 6s

The study is now up and running, evaluating pharmacokinetics [indiscernible] and safety of KAM-two thousand and fifty six versus current commercially available weekly semaglutide in participants with overweight or obesity are otherwise healthy. In the first part of this study, we are comparing two dosing schedules of KAM-two thousand and fifty six against the dose titration to label schedule, which is existing for weekly semaglutide. Following this different escalation regimes will be explored And aside from the approved indication of type two diabetes and weight management, I'm sure you have learned that GLP-one agonists like semaglutide may also have potential in inflammation neuropsychiatry and of keen interest to Camurus, for the potential treatment of substance use disorder. Before wrapping up, I can also mention that we have finalized the setting up of our new headquarters in Lund where we're currently sitting. And we have built here a state of the art lab tailored to our different needs from early to late stage development. And this will, of course, be used there to support our plan as planned business expansion during the coming years. Based on a very successful 2024, we have laid the foundation for 2025 where we expect to see increased pivotal penetration acceleration of Bixari sales in The U. S, obtain approvals for CAM-twenty twenty nine in acromegaly deliver clinical results for CAM-twenty twenty nine in polycystic liver disease and also for the new program KAM-two 56 In addition, we plan to diversify our business through business development activities, and overall contributing to a positive financial outlook for 2025 which we have shared earlier today and in this presentation by John.

1h 28m 22s

So Regarding the 2027 vision, we continue progressing in all four areas and remain on track to meet our target of revenue U. S. Commercialization, pipeline progress and operating margin. So with this as a final note, I hand over the call to our operator Q and A. Thanks. And our first question comes from the line of Victor Zombarsch from Nordea. Please go ahead.

1h 28m 54s

Yes. Hi. Thanks for taking my questions. So I had one on your guidance.

1h 29m

You gave quite much color on the cost side, but I just wanted to give some get some more detail on total revenue guide. So looking at Bouvedil and a specific 25. You previously talked about Germany and the challenges with reimbursement for long acting. So just wonder if there's any update here or another key geographies. Also on polycystic liver disease for KAM twenty nine, it looks quite At the risk study, given the data that we have seen in Sartostat in LARP. But I just wondered what the next steps would be if the study would read out well here in Q1. Could that be registrational? Or do you need a Phase three and how would that look like in terms of size control arm, etcetera? And just finally, I just wondered also around your M and A strategy. You're being quite forward at that you look for M and A opportunities. So any comment if that is still the case and what kind of assets you think could fit within your company at this stage? Thank you.

1h 30m 8s

Thank you, Victor. I mean, on the first question, I think we caught continue to see a lot of the drive in the large European countries, as Richard said, earlier. So that's and that includes, of course, Germany in The U. K. And but also more increasingly we see progress in Spain and also France and other countries. So that's I think our focus area from a geographical perspective. Richard, any more? No, nothing that comes When it comes to the politic liberties, it's of course that is a very interesting study for us, and this is an treatment. So I think you should regard this as a as we have said, a Phase twothree study. In The U. S, we do not believe it will suffice with one study. There is a potential In Europe, but our idea is to based on the data from the Phase two trial from Positano, we should formulate the Phase three trial, which we are currently planning. And we cannot say anything about the details here. We have been working on it for quite some time now and planning the design and also the timelines for the study. And I think we have a really good starting point here, but we need the data before we can finalize this and come up with the the powering of the trial and so forth.

1h 31m 36s

But so far, we have done a lot of work and I think overall looks interesting. So any follow-up questions on that, Victor, before we move on? Yes, sorry. Yes. I mean, the M and A strategy remains as previously communicated, we are chiefly targeting commercial assets or pre commercial assets. And which are synergistic to our current pipeline or commercial organizations in the different territories where we operate. [indiscernible] Into the queue. Thank you. Thank you. The next question is from Christopher Ude from SEB. Please go ahead. Your line is open. Hi there, Chris Rui from SEB. Thanks for taking my questions. I guess the first one is on the regulatory situation. Just to if there's any more clarity you could possibly give in so insight into the reasons for the OAI classification And is the establishment inspection report all that you need to be able to refile or What else might be necessary? And what if they say there are still deficiencies? What happens then?

1h 33m 8s

Yes, that's a very good question. I mean, overall, just to go back, we were expecting to get the classic much earlier. So in mid December and so forth, it's been quite a [indiscernible] It's an interesting dynamic right now at the agency. If I put it that way. However, I think we have a clear we know, of course, what the 483s are or as a matter of fact, they were quite satisfied with the state of those being addressed. We are not completely clear on the review history and that's why we need the EIR because we need to get clarity on whether or not there are any of the questions that are outstanding we suppose so. And if so, what the actions we believe are necessary? I think that having studied the 483s, there is nothing that seems to be from a time perspective very extensive in mitigating. So I think that we are in a good shape there. But we simply need the EIR to be able to better clarify whether or not we have resolved everything or if there is anything left to address by the manufacturer. On the positive note, we don't have anything, of course, with regards to the product.

1h 34m 47s

The product had we had no objections and no really no comments we were ready with labeling. So we should be able to move very quickly in terms of refiling.

1h 35m 1s

Okay.

1h 35m 2s

And then if I could ask another question around the guidance I guess in light of this, fair to assume that you're assuming an immaterial contribution from Oak Place in 2025? And then how about Bricksady because last year you had indicated indirectly that the guide from your partner was extremely conservative. We try to back that out for this year, what are you expecting for Bouvedil growth in 2025?

1h 35m 37s

No, I think that I mean, starting with the first question, you can regard Oakley's to be quite immaterial in terms of its contribution. When it comes to I'm not really sure about the the comment you made there regarding the partner, but I think that overall, they probably have quite realistic views. I cannot comment their views, and therefore, I don't want to to split the two components. So I think that you can regard a majority or a very large part of our guidance to be of the two Bivotal and Bixaidi, but we are not providing them separately at this point. Fair enough. In terms of I mean you had 4,000 patients added this last quarter. Is that the new floor?

1h 36m 38s

We don't have a floor. I mean, we have a target and we are tracking towards the target. Which is the 100,000 patients in 2027. We don't have a floor. I think it will vary by quarter. So we are not foreseeing that we will have a a constant or have a floor. It will be varying by quarter as we have seen previously. And I think that's Yeah. But our target remains.

1h 37m 7s

Yes. If I could just ask a couple more questions around the specific markets and I apologize, I had trouble hearing the answer on the remuneration in Germany. But let's say starting with that, and so the reform, what factors will determine the timing of that? And body decides? And do you have any insight into Yes, the reasons around that timing.

1h 37m 38s

We know the process but we have because we are a commercial company, we have to have a completely hands off approach here. So we are just following this from the sidelines. We understand that the reason among the different parties that are involved, which is the kind of insurance providers, it is the of course the medical community as well as the political dimension There's what we have understood is that there is a consensus that they need to change the current remuneration basis And we think that would be very good for in terms of providing German patients with a much better treatment option. Better treatment options [indiscernible] We understand from the latest updates that there is still expectations that this will be finalized in 2025. However, all of these processes are externally driven. So but I think there is positive view on that and positive development Got it. And then I guess So if we talk about England, France, Germany and Spain, which is performing relatively best versus your expectations as started 2024 and which the worst and what gating events in those markets might be required remuneration aside to occur in order to deliver on your guidance?

1h 39m 16s

Christopher, I don't think I mean, I think what in terms of performance, I think we have seen very strong performances across markets. So we're pleased with all of these markets that I mentioned and actually actually, I mean, we're seeing consistent growth There might be one or two markets that are having a slower pace this quarter, but overall very good performances So we are pleased with that, and we are also pleased with the fact that we are now able to go in and launch the products in three more countries, and we have processes ongoing in other countries as well. So we look forward to the market expansion possibility that has come up now both in Portugal and Switzerland. I mean Luxembourg is a very small country, but still they have 1,000 patients there approximately. So that's a very important part. And we will that market expansion process will continue here going forward. But I can't comment on specific countries.

1h 40m 21s

Yes, that's all for me.

1h 40m 24s

Thank you so much.

1h 40m 26s

Next question is from Oscar Hafen Lam from Brian Garnier. Please go ahead.

1h 40m 34s

Hi, Tim. Altsu here from BG. Thank you for taking my question.

1h 40m 38s

So on Bouvedo, I was wondering if you could provide some granularity on what percent market share you have in major European markets? And if you believe that the uptick in patients added on treatments this quarter will be maintained in the coming year

Key Insights

Strong Financial Performance in 2024: Camurus achieved SEK 1,868 million in total revenue for 2024, representing a 9% growth versus the prior year. Excluding one-time revenues, total revenue grew 42%. The company reported a gross margin of 94% and a profit before tax of SEK 553 million, an increase of 286% versus 2023.
2025 Guidance and Strategic Investments: Camurus provided a 2025 revenue outlook of SEK 2.7 billion to SEK 3 billion, representing a growth of 45% to 61%. Profit before tax is expected to range between SEK 0.9 billion and SEK 1.2 billion. The company plans to invest approximately SEK 200 million over the next two years to develop a second manufacturing facility and support new product launches.
Product and Market Expansion: Bouvedal sales grew by 27% year-over-year, with an estimated 60,000 patients treated by the end of 2024. The company expanded into new markets with reimbursement approvals in Switzerland, Portugal, and Luxembourg, with launches planned for early 2025. Brixadi achieved strong growth in the U.S., capturing approximately 25% of the long-acting buprenorphine market segment.
Pipeline Progress: Regulatory reviews for CAM2029 continued in the U.S. and EU, with a temporary setback in the U.S. due to a third-party manufacturing inspection issue. Clinical trials for CAM2029 in acromegaly, gastroenteropancreatic neuroendocrine tumors, and polycystic liver disease are progressing, with key data readouts expected in 2025. A new study for a once-monthly semaglutide GLP-1 product (CAM2056) has also been initiated.
Vision for 2027: Camurus remains on track to achieve its strategic vision of SEK 4.5 billion in total revenue and an approximate 50% operating margin by 2027, driven by continued growth in Bouvedal and Brixadi sales, as well as contributions from CAM2029 and other pipeline assets.

Recent Transcripts

Camurus achieved strong financial growth in 2024, driven by product sales and market expansion.

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Transcript

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Please go ahead.

26m 5s

Yes, hi. Thanks for taking my questions. So I had one on your guidance.

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But so far, we have done a lot of work and think overall looks interesting. So any follow-up questions on that, Victor, before we move on?

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Thank you. I jump back into the queue. Thank you. Thank you.

29m 38s

The next question is from Christopher Ude from SEB. Please go ahead. Your line is open.

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Okay.

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Fair enough. In terms of I mean you had 4,000 patients this last quarter, is that the new floor?

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Next question is from Oscar Hafen Lam from Brian Garnier. Please go ahead.

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Yes.

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The Oscar's original, just to check one aspect, The answer relates to general market shares. Your question was specific to prisons, or to general market shares? The general market shares, yes.

39m 40s

Okay. Thank you.

39m 42s

And then the second one was the VIP one failure.

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Okay, super helpful. Thank you. And maybe just one additional question.

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Thank you for taking my questions. Next question is from Matthias Hegloom from Handelsbanken.

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Okay. There's a slide saying Boveda bond penetration, SEK 3,000,000,000 at late stage product candidates $1,500,000,000 So maybe the $1,500,000,000 included Yes, exactly.

45m 16s

That's completely Yes.

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That's very helpful. Thank you so much. That's all for me.

46m 59s

Thank you, Mathias.

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Thank you.

47m 2s

The next question is from Victor Sombre from Nordea.

47m 5s

Please go ahead, Victor. [indiscernible] please go ahead.

47m 13s

Yes, sorry, I was on mute.

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48m 36s

What's that, Thomas? With regards to land [indiscernible] any difference there you expect from the smaller trials that's been done are they quite similar in your opinion?

48m 52s

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Okay. That's very helpful. Thank you.

49m 37s

Thank you.

49m 38s

The next question is from Patrick Ling from DNB Markets. Please go ahead, Patrick.

49m 45s

Thank you. Two short [indiscernible] about commercial and pre commercial assets that you're looking at.

49m 56s

Could you elaborate a little bit on how pre commercial you're actually looking? Are we talking late stage Phase three or maybe Phase two trials?

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52m 48s

To give us flexibility. And we also have new programs entering clinical phase and those, of course, also need clinical manufacturing resources. So that's the target.

53m 4s

Okay, great. Good. Thank you. That's all for me. Next question is from Dana Schutte from Pariato Securities.

53m 13s

Please go ahead, Dan. Thank you for taking my questions. I think Mos has been answered. Just one question on CAM 2,056.

53m 25s

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55m 13s

Okay. Thank you very much. [indiscernible] The next question is from Erik Holcord from Carnegie. Please go ahead, Erik.

55m 25s

Yes, hi. I have a question [indiscernible] Average price how that has changed?

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Over the course of 2024 and what you see in terms of pricing five in your major geographies. Is there any price cuts in certain markets that you have baked into the guidance?

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Thank you, John. So I will start with the business in Europe, Australia and The Middle East region.

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And finally, a paper that explored healthcare professional perceptions that showed high satisfaction for long acting bupropionorphine compared to both methadone and daily sublingual buprenorphine.

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Yes. Hi. Thanks for taking my questions. So I had one on your guidance.

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The product had we had no objections and no really no comments we were ready with labeling. So we should be able to move very quickly in terms of refiling.

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Okay.

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No, I think that I mean, starting with the first question, you can regard Oakley's to be quite immaterial in terms of its contribution. When it comes to I'm not really sure about the the comment you made there regarding the partner, but I think that overall, they probably have quite realistic views. I cannot comment their views, and therefore, I don't want to to split the two components. So I think that you can regard a majority or a very large part of our guidance to be of the two Bivotal and Bixaidi, but we are not providing them separately at this point. Fair enough. In terms of I mean you had 4,000 patients added this last quarter. Is that the new floor?

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We know the process but we have because we are a commercial company, we have to have a completely hands off approach here. So we are just following this from the sidelines. We understand that the reason among the different parties that are involved, which is the kind of insurance providers, it is the of course the medical community as well as the political dimension There's what we have understood is that there is a consensus that they need to change the current remuneration basis And we think that would be very good for in terms of providing German patients with a much better treatment option. Better treatment options [indiscernible] We understand from the latest updates that there is still expectations that this will be finalized in 2025. However, all of these processes are externally driven. So but I think there is positive view on that and positive development Got it. And then I guess So if we talk about England, France, Germany and Spain, which is performing relatively best versus your expectations as started 2024 and which the worst and what gating events in those markets might be required remuneration aside to occur in order to deliver on your guidance?

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Yes, that's all for me.

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Thank you so much.

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Next question is from Oscar Hafen Lam from Brian Garnier. Please go ahead.

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Hi, Tim. Altsu here from BG. Thank you for taking my question.

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Key Insights

Strong Financial Performance in 2024: Camurus achieved SEK 1,868 million in total revenue for 2024, representing a 9% growth versus the prior year. Excluding one-time revenues, total revenue grew 42%. The company reported a gross margin of 94% and a profit before tax of SEK 553 million, an increase of 286% versus 2023.
2025 Guidance and Strategic Investments: Camurus provided a 2025 revenue outlook of SEK 2.7 billion to SEK 3 billion, representing a growth of 45% to 61%. Profit before tax is expected to range between SEK 0.9 billion and SEK 1.2 billion. The company plans to invest approximately SEK 200 million over the next two years to develop a second manufacturing facility and support new product launches.
Product and Market Expansion: Bouvedal sales grew by 27% year-over-year, with an estimated 60,000 patients treated by the end of 2024. The company expanded into new markets with reimbursement approvals in Switzerland, Portugal, and Luxembourg, with launches planned for early 2025. Brixadi achieved strong growth in the U.S., capturing approximately 25% of the long-acting buprenorphine market segment.
Pipeline Progress: Regulatory reviews for CAM2029 continued in the U.S. and EU, with a temporary setback in the U.S. due to a third-party manufacturing inspection issue. Clinical trials for CAM2029 in acromegaly, gastroenteropancreatic neuroendocrine tumors, and polycystic liver disease are progressing, with key data readouts expected in 2025. A new study for a once-monthly semaglutide GLP-1 product (CAM2056) has also been initiated.
Vision for 2027: Camurus remains on track to achieve its strategic vision of SEK 4.5 billion in total revenue and an approximate 50% operating margin by 2027, driven by continued growth in Bouvedal and Brixadi sales, as well as contributions from CAM2029 and other pipeline assets.

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