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,

accelerate U.S. commercial preparations for CAM2020-9 in neuroendocrine tumors and polycystic liver disease. And enhance our manufacturing capabilities. From a commercial perspective, we continued strengthening our leading position in neuroendocrine treatment across geographies. The total sales increased by 29% year on year to 364 million SEC at reported rates. In the U.S., Bricsana shows strong and accelerating growth, resulting in an approximate threefold increase in sales and reliability in the first quarter versus Q4 2020. On the R&D side, we received FDA acceptance for the review of FDA proclase in October of this year. The corresponding application has now been submitted to the EMA. And outside the grammatically area, we prepared the surrender study of CAM2020-9 in neuroendocrine Importantly, we also started to advance several early development programs, including completing and previewing the assessments of the novel type. Based on the data received, 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, Camourous continued its development, delivering 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. Camourous achieved 390 million SEC total revenue in the quarter, delivering a growth of 37% versus same period last year, with product sales of 364 million SEC, growing 29% versus prior year and basically aligned with prior quarter. Shredded Scrun or appreciation has impacted negatively reported figures by 1% -on-year basis

and 30% versus prior quarter. Brixby sells in the US, delivering a 26 million SEC realty income in the quarter following its commercial launch on September last year. Company profit before taxes was 97 million SEC, achieving an annual per share after dilution of 1.32. Scrun or equivalent profit after tax of 78 million SEC in the quarter. Finally, our gas position has progressed positively, delivering the quarter ending at 2.3 billion SEC in 2020, including 1026 million SEC obtained by direct investment with shared issue carried out in January in the size of 2 million. Moving to the next slide, we can see the main components of our profit before taxes. Company gross margin reached .1% in the quarter, representing an improvement of 222 basic points versus 70. The improvement was driven by three major factors. Firstly, supply chain efficiencies driven by the Gobi-Darv volume scale up represented 200 basic points. Secondly, 60 basic points driven by the Brixby royalty. Thirdly, FX represents a negative impact of minus 45 basic points. Total objects reached 289 million SEC, representing a 57% increase versus .5% prior year, driven by the following factors. Marketing and distribution investment to support marketing penetration in own territories, expansion of Gobi-Darv into new markets, and US operations grew 23% to 93 million SEC. Administrative expenses aligned with corporate evolution to substantiate company development grew .5% versus .5% per year to 16 million SEC. R&D investment reached 180 million SEC, growing .5% versus .5% prior year, driven

by recruitment completion, positive trial, and progress in our pre-clinical 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. Camoros 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 SEC after transaction cost. And finally, the company executed AGM 2021 authorization to hedge employee stock options and social security costs, obtaining

22 million SEC. At the end of the quarter, Camoros has no debt. All in all, Camoros closed its first quarter 2024 with a strengthened financial position, interesting growth opportunities, and an easy contract to deliver 2024 market guidance. Instead of that, I would like to pass the word to Richard. Thank you everyone for your attention. John? So, we move over to a commissionization update. I'm going to start in the Camoros market and then I'll give an update on the state of Brickstar in the US. So, in quarter one, invoice sales improved. Algorithm at 29% versus previous year, 30% at constant exchange rate. 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 equal to the Q4. Importantly, though, underlying in-market demand remained 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 Bouvadelle and penetration in clinics and criminal justice settings. And we continue to hear the positive impact that Bouvadelle is having on treatment outcomes for patients with opioid dependence. To give some more granularity, we had good progress in the UK. We're in market, we continue to grow single digits and recruit new patients alongside accelerating access in criminal justice settings as NHS funding comes through. So, that said, this was 10% slightly by delays in that NHS funding due to the year end, the finished in March. In Australia, the recent government changes have reduced co-pay for patients and we see both numbers in treatment and the numbers on long-acting injectable broadband in Brooklyn Orphan growing. Also in the Nordics, France, Spain and the Meenu region all

grew well 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 Bouvadelle at the end of the quarter, which is approaching 30% of the Brooklyn Orphan 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 Bouvadelle in the region. We also continue to expand geographically and in Q1 achieved reimbursement approval in Ireland, which will allow us to expand Bouvadelle 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 US with the launch phase of Bricsardy, performance in the quarter in the US 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, though, we already have

an estimated 7,000 patients on treatment with Bricsardy. This excellent and thoroughly-programmed progress reflects the acceptance of the strong product profile and demand for Bricsardy in the country with a high medical need. The compelling messaging around Bricsardy is clearly resonating with US healthcare professionals and Braeburn continues to focus on the launch strategy and execution with a commercial team of more than 100 people. They have strong pair coverage already on par with other long-acting and general products in OUD and a channel development that provides quick and reliable access to Bricsardy. Based on the strong performance of Bricsardy in the US, 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 Bricsardy to prove our brings for those seeking treatment for a good attendance and data that supports the differentiated product profile. Firstly, a recent publication of an opiate-based product is showing a broad range of firms in need to individualise treatment and to hydrate doses for optimal treatment outcomes. And demonstrated blockade across the dose range for Bricsardy and Dull. Other publications from Australia show how long-acting Bricsardy is individually utilised in the context of broad utilisation of all treatment doses in rural clinical practice. So on that note, I will hand back to Frederick for an update on the pipeline. Thank you so much, Richard. I'll give a late update on the state's development update and focusing here on Camp 2020-29. During the quarter, we continue to advance the 2019 across-time indications, which are And the project is designed for both enhanced efficacy, improved patient convenience and also quality of life. As the clinical programme

has progressed with positive study data outcomes, our expectations for Camp 2020-29 across the indications have been reinforced. So moving to a short update on each programme, in Acromegaly, we have completed treatment of all patients in Acroenova to our long-term safety and efficacy study and we 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 Eau Claire has been progressing and we recently submitted a corresponding market authorisation application for Camp 2020-29 to the European Medical Agency. In Geptsnet, after completing enrollment at the end of last year,

we are now collecting the results. So we continue to meet our objectives and timelines for Camp 2020-29 across the indications and have several important milestones ahead of us in the coming year. These include final results from the core phase of Acroenova 2, which we expect to be able to present at the end of June. And FDA approval decision for Acromegaly by the 2nd of August, 2021, followed by the planned US launch of Oklesvá for treatment of Acromegaly in the US around the end of year end. In Geptsnet, we are expecting to finalise the core phase of the surrender trial in the next year.

So in parallel with the advances of the registration programmes, we continue to build our US commercial organisation to prepare for the planned Eau Claire's launch. The estimated market opportunity for Camp 2020-29 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 Acromegaly and 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 number of events that we are participating in with cameras and study investigators, sharing data from the Acro Innova programme and updating on surrender to a positive sample trials at scientific meetings throughout the year. The key upcoming conferences include the European Congress of Endoprenology in Stockholm We have a short update on the business of cameras. I am pleased with the performance of our teams and the partners that we are working with, continuing execution We have a very strong momentum for residing in the US, which we are very pleased with. The old NDA was accepted for review by the FDA and we are on track for an anticipated approval decision in October. In parallel, we have made significant progress on other pipeline programmes, including the ones I mentioned earlier today. Thank you for your attention. I

leave it over to Erik Hultgård to start out the Q&A.

Thanks, Erik. If you wish to ask a question, please press the pound key 5 on your telephone keypad. The first question comes from the line of Erik Hultgård from Carnegie. Please go ahead, your line is open.

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. I think you mentioned UK funding delay, but I assume it can't explain the full delta. So please provide some colour 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 FEMA project. First, have you looked in pre-clinical models on whether your fluid crystal technology can enable higher exposure of FEMA versus your original product in animal? I think as a reference with Oxford, I just achieved the higher exposure with CAMS 2029 compared to some of the stuff in LAR. I was just wondering if this could be the case at 12 for FEMA. And then just the short final one, when do you plan to publicly share the pre-clinical data generated on the monthly FEMA 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 say that. We did see a slight slowdown in the first two months to the quarter. Partly, as we said, it's the UK and the funding delay coming in there and some of the changes that are happening in Australia. Overall, I think it's just a slight slowdown in the quarter. We're back to growth now. We exit the quarter strongly. 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 there. 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. OK. 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 don't think that's the limiting aspect for our technology in terms of

semi-glutide. So 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. Whether or not from a bioavailability perspective, because that's the difference we are seeing in the Camp 2029 case, I don't think I can give you the indication that we have a significantly better bioavailability. Because here we're comparing essentially a non-formulated system, which theoretically should have 100% bioavailability compared to a formulated system. Does that answer your question,

Erik? Yes. So you mean in terms of bioavailability,

it's fair to assume that you will have some type of trade-off when you go from a formulated version after the monthly version. So it's fair to assume that. No, I don't think that assumption is not a kind of conform. On the contrary, I mean, with Camp 2029, we have 100% bioavailability. So we don't have...I would say that having improved bioavailability is something I cannot confirm. All right. I think my message is we can reach therapeutic levels across the current dose range. All right. Thank you. The next question is from Brian Balkin from Jeffries. Please go ahead. Hey, thank you, guys. The first question is around Bricsardie. So strong launch. I didn't see anything in the release. I just wanted to check if you saw any impact in the change to healthcare spiral attacks on Bricsardie in voicing new patient starts as in the...if you had reported that to be the case to them or subliquate. So again, what is the limit to the molecular size with your crystal test? Could you potentially go greater than 40 amino acids? And I'm just on the study. It's just partnered with Novonorbit and so what are the economic... And I've got a lot of questions, 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 on the cyber attack. On the other hand, yeah, so this has not been anything that we have been communicated by our partner in the US. Now we haven't asked specifically regarding this topic, but we haven't heard any information about that. So when it came to the second topic,

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

Oh, yeah. So, 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 kilodartons, but it's always difficult to generalize.

So that's of course much more than 30 amino acids. So that is not the limit. When you talk 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. That's a question if we see this part that we know. Yes, I mean, we have not announced anything about partnering or relationships with other parties in relationship to the -a-view type project. Got that. And then just thirdly, on the get-net that we got first half of 2025. Yes. So, we are not assuming that the performance is from the same level as the comparison of arms. And of course, it depends on which study you are referring to. Definitely, if you are referring to the clarinet study, which is 10 to the 12th. I mean, there you have the pressure of this pre-survival, which was very long. I would say that in that study, a lot of majority of patients were grade one patients with low proliferation rates when it comes to tumor proliferation. So, below two, we have a much broader and more representative population in Sorrento with a majority of the grade two patients.

So, from that aspect, they have more advanced neuroendocrine tumor estates. 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, is 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 Mathias Hegbrun from Hammersblanken. Please go ahead. Your line is open.

Thanks so much for taking my question, Mathias Hegbrun from Hammersblanken. I have two questions, please. So, on my calculation, sales of Huwe Dal in your largest market was slightly declined in low-to

-low currencies by 14% sequentially during the quarter. You referred to inventory fluctuation, but can you share what in-market sales growth is? So, in Australia, or was there any additional dynamic in the quarter that explained the performance in Australia? And then secondly, I guess on the monthly salmon, can you say anything why now? Because G1 and animals have been listed for molecular classes where food is listed. I think the presentation was already back since 2018. So, have you achieved a technology breakthrough that you couldn't accomplish before, or is there time left of IP that now has accelerated this program? So, thanks a lot, Mathias. Regarding your question about Huwe Dal, I think it's more appropriate to describe the Huwe. We look at the in-market performance, excluding the FX impact, and then the seasonality of the stocks. Just remember that Australia is going through a change of the supply model at the moment. The in-market trend that we see in the Australian market is in the range of 8%. And the technical, from question to answer, nobody needs to break through. And that's class. Yeah, that is class. 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, quite a number of studies. So, when we are speaking about this time, it was more because we have taken the decision to move ahead towards the clinic. So, we have optimized the formulation work. And we have got the pre-clinical data

that we felt was required for us to take the next step in various different pre-clinical settings and models.

That's clear. And then I have one for you.

Regarding the intellectual property question. So, I mean, SEMA, 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 face to look into this development.

Thank you. And then, yeah, that's clear. I have one follow-up. Or rather, not related to this, but coming back to Bricsodium and the impressive ramp and royalty. Is there any risk that there is some kind of stocking in Q4? The one that drove this three times sequential increase. I guess another way of asking is the royalty triggered by sales into the channel including potential stocking or is it driven by market tests? The royalty is not driven by what is put into the channel. It's what the channel is distributed to the customers. This doesn't mean that some of the merchandise can be distributed to patients. There can be a small difference in the channel. I'm trying to reply to your question, Matthias. If we go into this question, I don't think there is any tendency that this should be represented by a large stock up. On the contrary, the patient numbers have been provided. The patient numbers from Braeburn and they are reflective of the fact that the stock is being used. That's very clear. Thanks so much. Thank you. The next question is from Brian Garnier and Company. Please go ahead. Hello. Good afternoon. Thank you for taking my question. I just wanted to have a bit of an update on the buildup of the US organization and sales force. How is this moving along in regards to the launch of COMP 2020? You may be reminded that the sales force will be targeting you. Thank you. We are going ahead

and it's going very well. Right now, our focus is very much on the medical affairs side. Of course, the whole system backup, 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 same strategy in the US.

Yes. 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 it in and we already have our US president, but we also have the head of marketing and sales, our VP in the market. Right now, we are working in parallel to start developing how the product will be distributed into the markets. Supply chain model, patient model, and we are going

to support. In parallel, we are working quite intensely with failures to try to be sure that the product can be accessed as soon as possible in the market. And that's where is our focus for, I would say, Q2 and probably Q3. Then after the PEDUFA date, all the systems will be on board and we are trying to work with the head of the PEDUFA date to identify the relevant talent that can be used in our company. And I think to that, of course, you also asked about the targeting of the product in the market and we have been working very intensively with that. We have had a number of regional studies that performed and identified the prescribed libraries and also the center of the product. That is an activity that has been practiced several times and we are continuing. Any further questions from you, Maria? That's super helpful. Thank you. Okay. The next question is from the Ludo from STP. Please go ahead. Hi there. Thanks for taking my questions. So you previously enumerated why 2024 will be back in loaded and yet in Q1 you delivered in line with the midpoint of the top line guidance. So why did you not raise the guide? Should we interpret this to mean that you're less confident about the favorable factors impacting market access and reimbursement in the PEDUFA? I'm actually transpiring than you maybe were previously. That's my first question. I think what we're saying and communicating is that we're

basically tracking along the middle of our guidance. That's the response that we have provided now. If you're looking, obviously we'll have different models, but I think we have not found a reason to change our guidance at this point. We are expecting to follow this track going forward. John, do you have anything that you would like to add there? No.

So far our major investment areas are the US's public information. We disclose we intend to increase our investment level by 300 million SEC, most related to the US. 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. So if I remember okay, our company revenue has grown 37%,

which is likely the midpoint of the provides we get. The market was expecting 97 million SEC. But we have nine months to go and we expect to reach the investment of 1.3 billion SEC. We provide it in our guidance. So right now we are the first one to export it. Three months have started and we don't see so many reasons to change our guidance. Okay, great. And then I guess the second question would be, one of your competitors recently talked about partnerships with pharmacy grocery chains to be able to enable patients. To be able to administer the product in more convenient locations. So I guess close to the patient's home. 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. What extent are you feeling or noticing this impact? I think I understand the last question. I think I understand the last question. Can you repeat that? Yeah, sure. So to what extent do you feel this impact on what? On competition, I guess you have other long-term. Are you noticing it? Okay, that's a good question. That's

a very

good question.

So, I mean, we can start with that. I think that in most of our markets, or all of our markets, we haven't seen the competitive landscape change very significantly. I would say in any geographic territory yet. So, of course, the US is in a new situation, but otherwise in the markets where we are very strong, like Finland, extremely strong, we continue to see growth, which we, of course, are very happy with. And we haven't seen a big penetration of any competitive product yet. When it comes to alternate pathways and distribution models in the US, I would say that we have, and I think that 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 stock up or a... There was a difficult capacity limitation, you could say, in special clinics. And this model is being applied elsewhere, and I think there is a very important room scale. This is also an important initiative for patients in our different markets. And similarly, in the US, I cannot speak about this topic here, but I understand that it's the model that in India is developing, for instance. And of course, it's reasonable to expect that other parties are using similar approaches. But it is a very important thing, because, I mean, we should optimize pathways for these patients in the main treatment that's accessible, as possible, both regionally and in the large cities. And I think there is a large possibility in just improving these systems going forward. So, I can only confirm the importance of this. Okay, great. Thanks. And I guess my last question would be on the pipeline. What can you tell us about the additional GLP-1N, a lot of which you have been mentioning, including whether any is proprietary? And for some agglutide, would you seriously consider taking this to market without a partnership with Noble? Thanks. That's all for me. Okay. The first question we will communicate 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. On that note, when it came, what was the second

question? A partnership with Noble.

Oh,

yes.

I mean, we have only decided to develop the product up to and beyond first clinical trial, whether or not we will change our focus and do phase two or other trials, this would be a topic 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. Our primary intent is not to bring this to commercialization. Thanks very much. I cannot comment on the Noble question. The next question is from John H. from Tinder. Hi there, and thank you for taking my questions. So first of all, I'm glad that's on the quarter and particularly the development in the US. And I have two questions. So the first one is on the GLP-1 study related to the Noble Nordic Disc. 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 about the potential? And secondly, I understand that the development in BVD may be affected by stocking. Is this again related to the development in your working capital for the quarter? Okay. Starting out with the first question about GLP-1. So of course there are multiple considerations there. I mean everything from the titration process to therapeutic levels. I mean, I think the compliance is a bit different. And maybe the highest interest in groups is where compliance is challenging. But I mean, as you know, the general rule, the larger the timeframe between administrations, the better for the patients as long as you have the correct PK profile. So I think

the

benefits can

be everything from compliance, titration up to the efficacy and exposure range that you are able to cover with the product. And we are of course looking into all of these aspects. I think the second question I'll just leave over to John. Is that sufficient on the GLP-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 from me.

There are no more questions at this time. So I hand over to you, Fredrik. Okay. Thank you so much. I think all I want to say is thank you for joining this call. I look forward to giving you the next update in June, the 17th.