Camurus AB (publ)

Good day everyone and thank you for taking the time to join our first earnings call for 2024. So before starting the presentation please notice our forward looking statements. So the agenda for today's call includes first quarter highlights, financial results, we will then move to commercial and pipeline updates and finish off with a Q&A. And with me on the call today, as previously, are John Garay, our chief financial officer, and Richard Jameson, our chief commercial officer. So starting out with our highlights in the quarter, cameras had a productive first quarter with strong profitability and pipeline progress. Total revenues grew by 37% year-on-year to 390 million SEC, which is the midpoint of our provided guidance. with profit before tax in the quarter of close to 100 million SEC. Our financial position was further strengthened by a successful directed share issue to support inorganic growth opportunities to accelerate U.S.

commercial preparations for CAM 2023. and neuroendocrine tumors and polycystic liver disease, and enhance our manufacturing capabilities. From a commercial perspective, we continue strengthening our leading position in opioid dependence treatment across geographies, Juvenile sales increased by 29% year-on-year to $364 million at reported rates. In the U.S., Bricsad shows strong and accelerating growth, resulting in an approximate threefold the increase in sales and reliability in the first quarter versus Q4 of 2023. So on the R&D side, we received FDA acceptance for the review of NDA Proclays in in October this year. The corresponding application has now been submitted to the FEMA, and outside the Afgromegaly area, We progressed the surrender study of CAM 2029 in Rwanda and completed patient recruitment in the positive terminal class. including completing Preclinical assessments of non-verbal and non-multiple formulations of stem microtypes. We are preparing for our first clinical study, planned to be started towards the end of this year.

And with this short introduction, I will hand over to John for the finances.

Thanks a lot, Frederick, and good afternoon, everyone. During this quarter, Camorus continued its development, delivering a strong profitability and remaining on track to meet 2024 market guidance and 2027 vision. I would like to share now key highlights of our financial performance this quarter. Camurus achieved 390 million SEK total revenue in the quarter, delivering a growth of 37% versus same period last year, with product sales of 364 million SEK, growing 29% versus prior year, and basically aligned with prior quarter. Swedish kronor appreciation has impacted negatively reported figures by 1% year-on-year basis and 3% versus prior quarter.

Brick-sized sales in the U.S. represented a 26 million SEX royalty income in the quarter following its commercial launch in September last year. Company profit before taxes was 97 million SEK, achieving an earning per share after dilution of 1.32 trillion SEK. equivalent to a profit after tax of 78 million SEK in the quarter. Finally, our cash position has progressed positively, still reviewing the quarter ending at 2.3 billion SEK in 2017. including 1,026 million SEC-obtained V.I. Directed Shared Issue carried out in January in the size of 2 million shares. Moving to the next slide, we can see the main components of our profit before taxes. The company gross margin reached 92.1% in the quarter, representing an improvement of 222 basic points versus the same period prior year. The improvement was driven by three major factors. Supply chain efficiencies driven by Gubidal volumes scale up represented 200 basic points. Secondly, 60 basic points are driven by Brisa deroyality. And thirdly, FX represented a negative impact of minus 45 basic points. Total OPEX reached $289 million on SEC, representing a 57% increase versus the same period prior year, driven by the following factors. Marketing and distribution investment to support marketing penetration in non-territories. Expansion of Google into new markets. and U.S. operations grew 23% to 93 million seconds. Administrative expenses aligned with corporate evolution to substantiate company development grew 73% versus the same period last year to 16 million seconds. R&D investment reached 180 million SEC, growing 81% versus previous prior year, driven by recruitment completion, positive trial, and progress in our preclinical and clinical pipeline.

Company profit before taxes reached 97 million SEC, growing 26% versus prior year. Company cash position at quarter end was 2.3 billion SEC. Camorus improved its cash position by 1,084 million SEC in the quarter, driven by following factors. Firstly, company operations generated 139 million SEC. Secondly, working capital increased by 102 million SEC, driven mainly by inventory and receivables growth. Thirdly, company carried out a direct share issue, providing net proceeds of 1,026 million SEK after transaction cost. And finally, the company executed AGM 2021 authorization to hedge employee stock option social security costs, obtaining 22 million SEK.

At the end of the quarter, TAMURUS has no debt. All in all, Acamurus closed its first quarter 2024 with a strengthened financial position, interesting growth opportunities, and is on track to deliver 2024 market guidance. Instead of that, I would like to pass the word to Richard. Thank you, everyone, for your attention. Thank you, John. So we move over to a commercialization update. I'm going to start in the cameras market, and then I'll give an update. in the U.S. So in quarter one, invoice sales grew at 29% versus previous year, 30% at constant exchange rate, and plus 3% versus Q4 at constant exchange rate. After a strong Q4, we saw softer sales in January and February. However, as expected, in March, we exited the quarter strongly. Importantly, though, underlying in-market demand remains strong. and grew at 5% quarter-on-quarter, which more accurately reflects performance in the countries. Sharpened execution on our strategies and plans by the team across countries is driving both access to Bufordel and penetration in clinics and criminology. And we continue to hear the positive impact that Bupedal is having on treatment outcomes for patients with opioid dependence. To give some more granularity, we had good progress in the UK, where in the market we continue to grow significantly. high single digit and recruit new patients alongside accelerating access in criminal justice settings as NHS funding comes through. That said, this was slightly delayed in that NHS funding due to the NHS year end. end that finished in March. In Australia, the recent government changes have reduced copay for patients, and we see both numbers in treatment and the numbers on long-acting injectable buprenorphine growing, and we maintain our strong in the quarter, and we remain on track for our market guidance for product sales.

We now estimate we have more than 50,000 patients being treated with Buvidal at the end of the quarter. which is approaching 30% of the Buprenorphine segment where we have access, though, of course, with an estimated 750,000 patients in treatment in Europe and Australia, there remains a large opportunity for Buvidal in the region. We also continue to expand geographically, and in Q1 achieved reimbursement approval in Ireland, which will allow us to expand Buvidal use in treatment clinics across the country, and we have ongoing processes for both reimbursement and market authorizations in other countries. Now moving to the U.S. with the launch phase of Brixardi. Performance in the quarter in the U.S. saw accelerated penetration as shown by the large increase in our royalty stream from partner Braeburn. Royalty for the quarter was 26 million sec and based on information from Braeburn, after about six months since launch there we already have an estimated 7,000 patients on treatment with Brixardi.

Early progress reflects the acceptance of the strong product profile and demand for BricsRD in the country with a higher medical need. The compelling messaging around BricsRD is clearly resonating with U.S. healthcare professionals and BricsRD continues to focus on the launch strategy and execution with a commercial team of more than 100 people. And they have strong pair coverage already on par with other long-acting injectable products in OUD and a channel development that provides quick and reliable access to bruxardi. And based on the strong performance of BRICS-RD in the U.S., our expectations of reaching peak sales above $1 billion has been reinforced. We also continue to build and share the evidence base to highlight the advantage of BRICS-RD for those seeking treatment for opioid dependence. and data that supports the differentiated product profile. First, the recent publication of an opioid blockade affirms the need to individualize treatment and titrate doses for optimal treatment outcomes. and demonstrated blockade across the dose range for buprenorphine. Other publications from Australia show how long-acting buprenorphine is individualized in the broad utilization of all treatment doses in real clinical practice. So on that note, I will hand back to Frederik for an update on the pipeline. Thank you so much, Richard, and I'll give a link to the state's development update and focusing here on Chemtrails. And during the quarter, we continued to advance 2029 across top-rated indications, which are acromegaly, gastroenteropatria, and the neuroendocrine tumors, of course, as you have heard. were previously here, polycystic liver disease, and the problem that is designed for both enhanced efficacy, improved patient convenience, and also quality of life.

Our clinical program have progressed with positive study data outcomes. Our expectations for CAMP 2029 across the indications has been reinforced. So, moving to a short update on each program. In Acromegaly, we have completed treatment of all patients in Acruinova. to our long-term safety and efficacy study and will provide updated study results at the end of the second quarter building on the previously communicated positive interim results in parallel the fda review of occlase has been progressing and we recently submitted a corresponding market authorization application for camp 2029 to the european medical agency

In GetNet, after completing enrollment at the end of last year, we are now collecting data and monitoring progression-free survival events until we reach the target of 194 to read out the primary survival. are the endpoints. And in PLD, we completed during the quarterly enrollment of all 72 patients in the randomized study, which primary endpoint is to demonstrate reduced liver volume and improved symptoms in patients with symptomatic polycystic liver disease. So we continue to meet our objectives and timelines for CHEM 2029 across indications and have several important milestones ahead of us in the coming year. These include final results from the core phase of BlackBerry Nova 2. which we expect to be able to present at the end of June. And FDA approval decision for by the date of the 21st of October, 2024. followed by the planned U.S. launch of Oclase for treatment of acromagality in the U.S. around the year end. In GEPNet, we are expecting to finalize the core phase of the surrender trial in the first half of 2025, and then after obtained top line results on the progression-free survival and other key endpoints. This will and should allow an NDA submission to the FDA sometime during the second half of next year, and an application in other geographies they would, of course, follow as closely as possible. Finally, top-line results from Positano in the PLD indication are expected early 2025.

So, in parallel with the advances of the registration programs, we continue to build our U.S. commercial organization to prepare for the planned O'Klays launch. The estimated market opportunity for CAM 2029 across indications is significant and estimated in the region of about 1.5 billion US dollars. During the period, we started onboarding key functions in medical affairs, marketing and commercial. We also signed a lease for our new office space in Princeton, New Jersey. Market research has been ongoing, primarily for the AcromegADM net indications, providing insight on patient, prescriber, and payer perspectives, and enabling the team to build out their launch plan.

We have also been active with payer engagement and setting up the distribution and patient support model. Medical affairs activities have been accelerated in the quarter, and this has been reflected in the numbers. events that we are participating in with cameras and study investigators. We're sharing data from the ACRI-NOVA program and updating on surveillance and post-trial trials at scientific meetings throughout 2024. Key upcoming conferences include the European Congress of Endocrinology in Stockholm in the coming week. And later on in May, we are attending the ENDO meeting in Boston. which will be starting, I think it is the 30th of May this year. So with that short presentation, update on the basis of cameras. I'm pleased with the performance of our teams and the partners that we are working with. Continuing execution, which in the quarter has delivered revenue and profitability in line with guidance. robust in-market growth for Buvidal, and a very strong momentum for Bricsady in the U.S., which we are very pleased with. The off-taste NDA was accepted for review by by FDA, and we are on track for an anticipated approval decision in October. In parallel, we have made significant progress on other pipeline programs, including the ones I mentioned earlier today. ended the quarter with a strengthened cash position of $2.3 billion to support future organic growth and also inorganic initiatives. So, with that, I thank you for your attention, and I leave it over to Eirik Hultgård here to please start out the Q&A.

Thanks, Erik. If you wish to ask a question, please press pound key five on your telephone keypad. The first question comes from the line of Erik Hultgård from Carnegie. Please go ahead. Your line is open.

Yes, hi there. Thanks for taking my questions. I have a few, if I may. First on Buvidal, the pace of quarterly patient growth slowed to 2K from being stable at 3K the past two years. And I think you mentioned UK funding delay, but I assume it can't explain the full delta. So can you please provide some color here and more specifically if you're starting to see a saturation in some of the early launch markets. And then I have two on the monthly SEMA project.

First, have you looked in preclinical models on whether your fluid crystal technology can enable higher exposure of sema versus the origin of products in animals. I think as a reference, with octetide use, with the higher exposure with CEMS 2029 compared to some of the stuff in R. So I was just wondering if this could be the case 12 for SEMA. And then just the short final one, When do you plan to publicly share the clinical data generated on the monthly seminar today? Thank you. Thank you. So I think we'll let Richard start with a question about the softening in January and February. Yes, I'm happy to take that. Yeah, we did see a slight slowdown in the first two months to the quarter. the UK and some of the changes that are happening in Australia. Overall, I think it's just a slight slowdown for the quarter.

We're back to growth now. We

And we believe that we're going to pick up that growth rate the same as we were. I don't think it's around saturation. As I said, there's a lot of patients needing treatment in Europe. And we still have a long way to go and a lot of opportunities. And I think we're seeing increasing demand from patients for long-acting treatments as well, so we only see that accelerating in the future. moving over to your question about higher exposure I think what we see is that we have quite good flexibility in terms of exposure and I can say that I don't think that's the least limiting aspects for our technology in terms of .

So, I mean, there are many other considerations, of course, in this treatment, and they have to be considered, but I think we can say that with strong confidence that we can provide significant overall exposure during the treatment period. um whether or not it from a bioavailability perspective because that's that's the difference we are seeing with in the camp 2029 case i i don't think i can give you the indication that we have a significantly better bioavailability because here we're comparing a non-form essentially non-formulated system which theoretically should have 100 by availability compared to a formulated system is that

Yeah, so you mean, so in terms of buy availability, it's fair to assume that you will have some type of trade-off when you go from, when you go to formulate the sort of version of the market. No, I don't think you, that assumption is not kind of confirmed. On the contrary, I mean, with 1039, it's So we don't have, I would say that, but having it improved, it's something I cannot confirm. All right. My message is we can reach therapeutic levels across the current dose range. All right. Thank you. The next question is from Brian from Jefferies. Please go ahead. Your line is open. Hey. Thank you, guys. First question. around BrickSardi. So strong launch. I couldn't see anything in the release. Just wanted to check if you saw any impact in the change to healthcare cyber attacks on BrickSardi in voicing new patient starts as indeed if you had reported that to be the case to them or sublocate. Stacking this up again on that GLP-1 phase 1 study, I guess, what is the limit to the molecular size with your or blue crystal test, could you potentially go greater than 40 amino acids? And then just on the study, is this partnered with Novo Nordisk? So what are the economics? And I've got a third question, but I'll stop there now. Okay.

So, I mean, if we start with your first question here, I don't think we have seen and we haven't heard any reports that we had any impact of a cyber attack. On the other hand, yeah, so this has not been anything that we have been communicated by our partner in the U.S., Now we haven't asked specifically regarding this topic, but we haven't heard any information about that. So when it came to, yeah, the second topic.

Can you... The second topic is which is the limit of the molecule size?

Oh, yeah. Sorry. I mean, I think we have successfully formulated and performed preclinical studies for peptide or small protein compounds, at least up to 20 kilodaltons. But, you know, it's always difficult to generalize.

So... of course, much more than 30 amino acids. So that is not the limit. When you're talking about these things, you have to consider many different aspects, but I would say that we are not limited to 30 amino acids, for instance. Yes, I mean, we have not announced anything about part or relationships with other parties in relationship to the type project. Got it. And I just... Thirdly, on the GetNet study, we got first half of 25. It is tough to understand how the tougher patient population in the Sorento study could mean that the comparator arms standard Yeah, we are not assuming the performance from the for the comparison of arms. Of course, it depends on which study you're referring to. Definitely, if you're referring to the clarinet study, which is a form. I mean, there you had a progression of his pre-survival, which was very long. I would say that in that study, it was essentially the lower majority of patients were grade 1 patients. with low proliferation rates when it comes to tumor proliferation, so below 2. We have a much broader and, in a sense, more representative population in sorrento with a majority, actually, of grade 2 patients.

So from that aspect, they have more advanced neuroendocrine tumor states, and we also have higher KI67 proliferation index values. So I think that's the basis that we have had in our assumptions, and I think the population We assumed when we started the study, it's very much reflecting the population that we now have in the study after recruiting all patients. Anything else, Brian? Great. That's fantastic.

The next question is from Mattias Hegde from Handelsbanken. Please go ahead. Your line is open.

Yeah, thanks so much for taking my question, Mattias. I have two questions, please.

So on my calculation, sales of Hovedal in your largest market, Australia, declined in local currencies by 14% sequentially during the quarter. You referred to inventory fluctuation. But can you share what in-market sales growth you saw in Australia, or was there an additional dynamic in the quarter that explained the performance in Australia? And then secondly, I guess on the Can you say anything about why now? Because GP1 and animals have been listed for molecular classes where . I think all of the vaccines 2018. technology breakthrough that you couldn't accomplish before, or is there time left of IT that now has accelerated this program? So thanks a lot, Mattias, regarding your question about if we look at the in-market performance, including the SX impact, and then the seasonality of the stocks. Just remember that Australia is going to change the supply model at the moment. The in-market trend that we see in the Australian market is in the range of 8%. So, yeah, when it comes to the breakthrough in this case, first of all, I should say that We have been working with this program for some time. I cannot go into details about that. We have made some significant optimization efforts and, of course, done quite a number of studies. So when we are It was more because we had taken the decision to move ahead towards the clinic. But we have optimized the formulation.

work and we have got the preclinical data that we felt was required for us to take the next step in various different preclinical settings and models.

That's clear.

And then I have one follow-up. No. Yeah, regarding the intellectual property question. So, I mean, semis, as we understand it, depends on geography, but it's an interesting time range, 2029, I think the original patent expires, but they have patent extension term that goes to 3132. We'll see how that finally will pan out, but it's a good time and phase to look into this development.

Thank you. Yeah, that's good. I have one follow-up, or rather not related to this, but Coming back to BrickSolid and the impressive ramp and royalty generation in the first quarter. So is there any risk that there is some kind of stocking in Q4?

Q1, that growth is three times sequentially increased.

I guess another way of asking, is the royalty triggered by sales into the channel, including potential stocking, or is it driven by in-market sales? The royalty is not driven by... what is put into the channel is what the channel is distributing to the customers. This doesn't mean that all the merchandise can be distributed to patients, because there can be small levels in the channel. I'm trying to reply to your question, Matthias. If we go into this question also, I don't think there is any tendency that this should be represented by a large stock up. On the contrary, the patient numbers that have been provided or patient numbers from Braeburn and they are reflective of the fact that the stock is being used in the market. Thank you. That's very clear. Thanks so much. Okay. Thank you. The next question is from Maria Vara from Brian Garnier and Company. Please go ahead. The line is open. Hello, good afternoon. Thank you for taking my question. I just wanted to have a bit of an update on the build-up of the U.S. organization and sales force. How is this moving along in regards to the launch of COMP 2029 in the U.S.? ? You may be reminded of the sales reps that you will be targeting. Thank you. So, yeah, we are going ahead, and it's going very well.

Right now our focus is very much on the medical affairs side, and of course the whole system backup. So we have everything from compliance to other functions are now put in place in the US. In terms of the strategy going forward, I think I'll leave over to John. Maybe you can just give a summary of where we are with the strategy of the same strategy in the US.

Yes, so where we are in terms of the sales strategy and sales team is we are going to build it up on a phase side. We are bringing in, and we already have, as we have disclosed, our US president, but we also have the head of marketing and sales, our VP in the market, and right now we are working in parallel to start developing how the product will be distributed into the market, so supply chain model, patient hub model,

and which are the partners that we are going to support into this area. In parallel, we are working quite intensively with payers to try to be sure that the product can be accessed as soon as possible. in the market, and that's where it's our focus for, I would say, Q2 and probably Q3. Then, after a few days, all the sales force will be on board, and we are trying to work that can be in our company. And I think to that, of course, you also asked about, you know, the target thing. of the product in the market, and we have been working very intensively with that. Both the own studies, we have had a number of regional studies to perform and identify the prescribed risk and also the central stuff of largest interest. So that is an activity that has been prioritized and we are continuing. Further questions from you? Maria? Yeah, great. That's super helpful. Thank you. Okay. That's all from my side. The next question is from Christophe Lude from SCB. Please go ahead. You're welcome. Hi there. Thanks for taking my questions. So you've previously enumerated why 2024 will be back and loaded, and yet in Q1, you delivered in line with the midpoint of the top line guidance. So why have you not raised the guide? to mean that you're less confident about the favorable factors impacting market access and reimbursement in the EU5 actually transpiring than you maybe were previously? That's my first question. What we're saying and what we're communicating is that we are basically tracking along the middle of our guidance.

That's the response that we have provided now. And if you're looking, I mean, obviously we'll have different models, but I think we have not found a reason to change our guidance at this point. And we are expecting to follow this track going forward. I mean, John, do you have anything that you would like to add there?

No. So far, our major investment areas are the U.S. It's public information. We disclose we intend to increase our investment level by 300 million SEC, mostly related to the U.S. And we are progressing online with our activities. So the investment will increase, especially in the second half of the year. And right now, we are aligned with the guidance we have provided.

In the top line, if I remember okay, our company revenue has grown 37%, which is exactly the midpoint of providing guidance for the full year, 33% to 42%. true that our profit before taxes has been strong. The market was expecting 97 million cheques. But we have nine months to vote and we expect to reach the investment of 1.3 or 1.3 billion assets. We provide it in our guidance. So right now we, is the first quarter, three months have started. see so many resources to change. I don't know about that. Okay, great. And then I guess my second question would be, so one of your competitors recently talked about partnerships with pharmacy grocery chains to be able to enable patients to administer the product in more convenient locations, so I guess close to the patient's Is this something that you guys are working on? Do you see it as a potential key driver or is it just one more piece of the puzzle? And then I guess while I'm still on the subject of OUD, In terms of competition in some of your early launch markets, you now have more than you had before, perhaps. To what extent are you feeling or noticing this I think that's the last question. Can you repeat that? Yeah, sure. Of competition, I guess you have other long accuracy. Okay. Are you noticing it? Okay. That's a good question. That's a very good question.

so yeah i mean we can start with that i i think that in most of our markets or all of our markets we are we haven't seen the competitive landscape change uh very significantly uh i would say in any geographic territory yet so of course us is a new situation but otherwise uh in the markets where we are very strong like finland uh extremely strong we are we we continue to see growth so which we of course are very happy with and we haven't seen a big penetration of any competitor product yet when it comes to you know alternate pathways and and distribution models in the us

I would say that we have, and I think we have mentioned this in earlier presentations, that we have developed a kind of pharmacy chain injection model which is being used especially in the Australian territory because there were kind of a or there was a digital capacity limitation, you could say, in specialty clinics. And this model is being applied elsewhere. And I think there's very important room This is also an important initiative for patients in our different markets. Similarly, in the U.S., I cannot speak about this topic here, but I understand that it's the model that Indivior is developing, for instance. And of course, it's reasonable to expect that other parties are are using similar approaches. But it is a very important thing because, I mean, we should optimize the pathways for these patients and make treatment as accessible as possible, both regionally and in the large cities. And I think there's a large possibility in just improving these systems going forward. So I can't really confirm the importance of this. Okay, great. Thanks. And then I guess my last question would be on the pipeline. What can you tell us about the additional GLP-1N including whether any is proprietary. And for semaglutide, would you seriously consider taking this to market without a partnership with Noble? Thanks. That's all from me. Okay.

The first question we will communicate, you know, as we go along, specifics.

At this point, I think this is not our intention, but we have some interesting programs going forward. They are still a little bit earlier in terms of development, so therefore we are not choosing to communicate. um yeah on on that note when it came what was the second question oh yes i mean we are we have only decided to develop the product up to and beyond first clinical trial whether or not you know we will change our focus and and do phase two or long other trials this would be a topic for for the future but obviously we are not expecting to be marketing products in the large indications here but this is something that we will think about and communicate going forward but our primary intent is not to break

bring this to commercialization. Thanks very much. I cannot comment on the normal question. The next question is from . Hi there, and thank you for taking my question. So first of all, congrats on the quarter and particularly the development in the U.S. and And I have two questions. So the first one is on the GLP-1 study related disk. And I guess the idea here is to open up for monthly shots. But is there also other benefits to this? And can you say something? thinking about the potential. And secondly, I understand that development in Bovidal may be affected by stocking. Is this again related to the development in your working capital for the quarter? Yeah, well, starting out with the first question about GFP1, of course, there are multiple considerations there. I mean, everything from... process to therapeutic levels or to dose increases to convenience of weekly or monthly treatments and this is all Also, depending on the patient group, of course, the longer duration problems have specific and maybe the highest interest in groups where compliance is challenging. But I mean, as you general rule, the larger the time frame between administrations, the better for the patients as long as you have the correct PK profile. So I think the

The benefits can be everything from compliance, titration, up to the efficacy and exposure range that you are able to cover with the product. So, and we are, of course, looking into all of these aspects. I think the second question I'll just leave over to John. Are you, is that sufficient on the GLB-1? John? All good.

And regarding working capital, the answer is yes. Actually, the increase in our inventories is due to that. But also, we have made a conscious decision to try to increase the stock levels in raw materials aspect. So this is a conscious company decision. So it's a combination of both.

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

There are no more questions at this time, so I'll hand the word back to you, Fredrik. Okay. Thank you so much. I think all I want to say is thank you for joining this conversation. I look forward to giving you the next update in June or July the 17th.