Camurus Ab

Hello, everyone, and welcome to our third quarter earnings call. I'm pleased to present another productive and financially strong quarter for Camerus. Before starting the presentation, please note our forward-looking statements. So here is today's agenda, which includes a short introduction with third quarter highlights, followed by financial, commercial, and R&D updates. With me on today's call is our CFO, John Garay, and our Chief Commercial Officer, Richard Jameson. As I mentioned, we had a good third quarter. Financially, it was our best to date, where we delivered positive operation results for the third quarter in a row. And strong cash flow contribution of 90 million SEC. Based on the development, we raised our guidance for full-year operations result by 45 million SEC in the interval midpoint. Privadol continued to gain market share. We reinforced our leadership position in the opioid dependence market in Europe and Australia and continued our market expansion efforts with new regulatory and pricing approvals. On the R&D side, we continued to progress our late-stage pipeline programs including variation applications to expand the indication for Bovidal to include chronic pain. We reached a significant milestone of finalizing recruitment in our ongoing phase 3 trial in acromegaly, and we also started dosing of patients in a phase 2b study in polycystic liver disease. Finally, we held our capital markets and R&D day in Stockholm, and presented our five-year vision for growth and innovation for cameras. And here I want to thank you, everybody who participated in this meeting and made it such a great event. So with this very brief introduction, I'll hand over to John for a financial update.

Thanks a lot, Fredrik, and good afternoon, everyone. We would like to share with you now the main highlights of our financial performance this quarter. From a total revenue point of view, Camurus achieved 241 million SEK in the quarter, delivering a growth of 57% versus same period last year and with product sales of 241 million SEK growing at 58% versus prior year and 7% versus prior quarter. Operating result for the quarter was positive and reached 41 million SEK meaning a 48 million SEK improvement versus third quarter last year. And the trend, displayed by the chart, shows our commitment to profitability. Company achieved an earning per share in the quarter before dilution of 0.63 kronor, equivalent to a profit-added tax of 35 million SEK in the quarter. On a year-to-date basis, company revenue was 688 million SEK growing 65% versus prior year, delivering a 53 million sec operating result and a 42 million sec positive profit after taxes. If we now move to next slide, we can see the main components of our operating result this quarter once revenue has already been covered. Gross margin reached 217 million sec, improving 360 basic points versus same period prior year. and delivering at 89.1% year-to-date. Three factors explain our gross margin improvement. Firstly, 200 basic points driven by efficiencies in our manufacturing and supply chain operations. Secondly, 85 basic points driven by better country and price mix. And finally, 79 basic points driven by FX. On the OPEC side, company reached 184 million SEC which is a 32% increase versus same period prior year, driven by following three factors. Firstly, marketing and distribution investment to support our market penetration in own territories and expansion of Boobidal into new markets. Secondly, administrative expenses driven by corporate functions development. And thirdly, R&D progress in the three indications of our CAN 2029 programme. Company operating results became positive by 41 million SEK in the quarter and 53 million SEK GR to date, mainly driven by sales growth and gross margin improvement. As we continue our investment in our pipeline to bring product candidates to market, it may still take a couple of quarters to see our profitability stabilizing. At this point, Frederick and I want to communicate to you all an improvement in our operating result full GR guidance. from revised guidance range of minus 20 million SEK to plus 40 million SEK to an improved range of plus 40 million SEK to plus 70 million SEK. If we now move to next slide, our cash position at quarter end was 520 million SEK, delivering a 22% growth versus same period prior year. Camurus generated 90 million SEK cash in the quarter, mainly driven by strong operations, generating 55 million SEK cash, and warrant program exercised by our employees, generating 37 million SEK. As you may see in the graph, our business growth has almost required no investment in working capital. And as end of quarter, Camurus has no debt. Our guiding principles for capital allocation continue being, firstly, reinvest in our business with two clear objectives. On one hand, to accelerate booby-dung market penetration and geographical expansion, and on the other hand, bring CAN 2029 program to market as planned. And our second guiding principle is to support our company strategy in the area of synergistic M&A opportunities, enhancing our company value. Thanks a lot, everyone, for your attention. And now I would like to pass the word to Richard.

Thank you, John. As already mentioned, Boverdale sales grew 58% year on year and 7% versus the previous quarter. As expected, growth was impacted by the vacation period in some markets in Europe, with fewer patients initiating treatment, but then picked up again in September. Notable growth was seen in the UK, where a new funding started to become available after the government's decision to invest in improving the treatment system. In numbers, we passed the milestone of having sold more than 1 million Buvedal units since launch and now have more than 32,000 patients in treatment at the end of the quarter. Our market expansion success continued with new regulatory approvals in Egypt and Saudi Arabia, where Buvedal became the first approved maintenance treatment for opioid dependence. and launches are planned in Q4 in those markets. We also expanded our reimbursement in Belgium, taking away hurdles and opening up for distribution by our community pharmacies, and announcing a very high interest among prescribers in that country. In addition to granted approvals, we have five additional regulatory applications under review with expected approvals in 2023. We remain committed to share the growing evidence for treatment with Buvedal at international meetings and congresses, And as you can see, our medical teams are very active across our geographies. In addition, we see continued flow of publications describing use and treatment outcomes with Buvidal, and we have several new publications underway. Moving to the next slide and an update on information about the market expansion process in the US, where our latest news from Rayburn is that The FDA inspections of Braeburn's third-party manufacturer are about to be completed after various interruptions, including COVID and other external factors. We're now waiting for information about the inspection outcomes and time for resubmission of the Bruxardi NDA to the FDA. As we've mentioned previously, the nominal time for resubmission to approval is two or six months, depending on the FDA's classification. In waiting for the treatment to come available in the U.S., we are pleased that more than 2,000 patients have or will receive Brixardi in ongoing investigator-initiated trials, generating more experience and building the evidence base across the clinical settings in the US. On that brief update, I'll hand back to Fredrik for the R&D.

Thank you so much. And let's move over to an update of our latest R&D developments. And here are our phase three and phase two clinical programs for CHEM 2029. in rare diseases continued to progress during the quarter, along with programs for CAM4072 in genetic obesity diseases, as well as CAM2043 in Raynaud's disease. We begin with an update on 2029, our octreotide subcutaneous depot product. It's being assessed as an investigational treatment in three rare disease indications, as I mentioned, acromegaly, gastroenteropancreatic neuroendocrine tumors, and polycystic liver disease. The goal is to develop a best-in-class therapy with potential for enhanced efficacy as well as improved patient convenience and quality of life, and in the case of PLD, the first approved treatment. In acromegaly, we have made good progress with our two phase 3 trials during the quarter, Recruitment has been completed in the randomized phase three efficacy trial, and we reached our enrollment goal of 70 new patients in the long-term safety study. Based, among other things, on requests by patients and investigators, we have recently extended the study, the long-term safety study, by an additional 12 months period. to continue to follow patients in the study in parallel with our regulatory submissions. We have a really exciting year ahead of us. Top-line phase three results expected around the end of the second quarter 2023, followed by long-term safety results in the second half of the year. And then submissions of the first regulatory applications late 2023, early 2024. In parallel, we will be ramping up our pre-launch preparations, including building a US commercial organization in time for a possible NDA approval late 2024. So we also had very good progress in our phase three trial in neuroendocrine tumors. The study is uniquely designed to assess superiority in progression-free survival with CAM2029 versus current standard of care with octreotide LAR or lanreotide autogel. This is the largest randomized controlled phase 3 trial performed in this indication area today, and we have now recruited over 25% of the target 302 patients that will be enrolled in the study. Patient recruitment is expected to be completed mid-2023. And the efficacy part of this study will be completed after 194 progression events have occurred. Based on the expected progression-free survival for the two groups, we are planning for regulatory submissions in 2025 in this indication. We have a large and growing interest in the study among investigators and patients, and a great steering committee of leading international key opinion leaders as well as uniquely a patient representative who brings important patient perspectives into the trial and also the study conduct. So talking about neuroendocrine tumors, today is the 10th of November. It is the World Net Cancer Day, supported by Camuris, among others. And the purpose of this day is to improve awareness of neuroendocrine tumor cancers. pushing for scientific advancement with focus on identified unmet medical needs for patients and promoting the 32 member organizations from 26 countries located around the world. So this is, I think, a very interesting initiative. Moving over to our last indication, polycystic liver disease, we have during the quarter started dosing of patients in our phase two trial for treatment of PLD. PLD is a rare genetic and chronic disease with high unmet medical need and currently no approved medical treatment. Here we have started a three-arm randomized trial with primary endpoint being to study liver volume. And a key secondary endpoint in the study is KAMURI's in-house developed patient reported outcomes symptoms tool, which we call PLDS. This has been developed in close collaboration with the US FDA. We plan to complete enrollment in this study during the first half of 2023 and are expecting top line results in 2024. So all in all, we have an impressive clinical program ongoing with 2029 and many near and mid-term value triggers. Before I conclude, I would just like to mention two other programs in our pipeline. First, I mentioned that earlier, CAM4072. our long-acting formulation of Cetmelanotide, which we have in development, or which is being developed by our partner, Rhythm Pharmaceuticals, for treatment of rare genetic obesity diseases. Rhythm has been progressing a phase 3 trial of CAM-472 during the quarter. It's a switch study from daily injections, and we are expecting top-line results here sometime in 2023. In addition, they are planning to start a second phase 3 trial. Now it's scheduled for the first half of next year. That's slightly delayed compared to the previous plans. In the quarter, finally, we also completed the clinical trial report for our phase 2a study for the Trepostinil Depot CAM2043. where one of the most interesting observations in the study was the significant effect seen in the Reynolds condition score after a single dose of CAM2043, and actually up to 15 days post administration. Following discussions with investigators, key opinion leaders, and also performing updated market research, we are now planning to start a follow-up clinical study next year in this indication. So with that, let's finish off with some key takeaways from the third quarter. I'm very pleased with the overall development and performance in a challenging environment where we have shown good top and bottom line growth and were profitable for the second consecutive quarter. We continued our market expansion with approvals in EU and MENA. opening new possibilities and strengthening our position outside our core markets. Our late stage pipeline progressed according to plan and we have several important milestones coming ahead of us, including top line results from up to three phase three trials next year. Finally, we raised our company operating results guidance confirming profitability in the full year 2022. So with these last remarks, let's move over to Q&A. And operator, please take over the call.

Thank you. If you wish to ask a question, please dial 01 on your telephone keypads now to enter the queue. Once your name has been announced, you can ask your question. If you find it's answered before it's your turn to speak, you can dial 02 to cancel. Our first question comes from the line of Susanna Quekborna of Handelsbanken. Please go ahead. Your line is open.

Hello, Susanna Quekborna, Handelsbanken. Thank you for taking my call. I have three questions. First of all, you shared a graphic of 37,000 patients by the end of the year. with currently 2,000 patients added during Q3, that takes you to 32,000. Do you think it's still possible to actually reach your estimate of 37,000 by Q4? Is this appropriate?

Oh, thank you, Susanna. Yeah, sorry. Please go on.

No, no, please. I think maybe one at a time is easier.

Yeah. Yeah. Yeah, I think, I mean, our view is that this is still possible. It is slightly challenging, but we have, our projections are not deviating at this moment. So let's see when we end the year. We're working hard, or Richard is.

Great. Okay. And then how should we think about CAM 2029 with the clinical trials going forward? At the CMD, you signaled that post 2023, number of active um cam 2029 trials would decrease but now um you talk of the long-term safety study is being extended to allow treatment and assessment of patients for a further 12-month period um i i believe that that co innova 2 and so that would mean it would potentially spill into 24 and 25 and i know you said that doesn't necessarily impact your regulatory um timeline but How should we think about this decision? Will this support your regulatory submission? And why is there need for this additional expense?

A very important reason, of course, is that these patients will be able to continue staying in treatment for a longer period of time the time that the submission is being reviewed and before approval. And basically, the additional cost of this, we think, is well compensated by the value that this is providing. So this is nothing that impacts our timelines from an approval standpoint, but it's something that will yield a lot of valuable information to us, also about the long-term use of CAMP 2029 In these studies, we are studying a lot of patient-reported outcomes, and this is valuable information once we are in the launch mode. I think it's well-invested money, and it's covered by our projections.

Okay, and then a final pipeline question on CAM 2047. I remember from the Q2 report, but now again, that you were unable to reach the primary endpoint for the phase two trial here. And I'm trying to understand why or how you're still pursuing this rather than other reformulations, for example.

Well, I mean, we are certainly working with a lot of other, you know, early phase programs and that's not impacted by this. The outcome of our discussions with our investigators and as well as key opinion leaders and having performed the market research makes us, you know, take the decision that we want to progress with another study to resolve and understand a few things that are outstanding for us. And then possibly going into a registration study. So that's the situation right now. And we will, of course, update on this. But we think it is a wise decision to take, of course. Otherwise, we wouldn't have.

Okay. Thank you.

Thank you. Our next question comes from the line of Victor Sambay of Nordea. Please go ahead. Your line is open.

Yeah, hi, and thank you for taking my questions. I have three questions, if I may. So on R&D costs, I noticed that they were down quite a bit in this quarter versus last quarter. So I just wanted to understand what's driving that, if you can elaborate a bit on that, that would be helpful. Thanks.

Yeah, overall, I mean, I can leave over to John here soon, but I mean, Our clinical studies and costs are very milestone driven. So they are going a little bit up and down, but I'll leave it over to John to talk about the details there.

Basically, Victor, that's the answer. So in Q2, we were reaching certain milestones in acro study mainly. In Q3, we were not planning to reach those. We have planned them in mid-October, in which, as Fredrik has announced, the screening and patient enrollment in the 63 study is completed, and this is where we have the the milestone. Nothing strange for us is normal to have this up and down in the R&D driven by milestones, Victor.

Okay, perfect. Thank you. And also, I'm a bit curious here also about Australia. So I was a bit surprised that Australia did not deliver high LSAVEs given the favorable favorable FX movements in the quarter. So I just wonder what the dynamic was for the Australian market in this quarter.

Yes, I think if I can be wrong, but if I remember well, we do not disclose Australia and sales separately. I think we disclose Asia, including Oceania, which is Australia. And perhaps what you are referring to is that in this segment, in Q2, we had 93 million SEC And sorry, in Q3, we have 93 million SEC, and in Q2, we have 105 million SEC. So you see a slight decline in there. Is this the topic you are referring to, Victor? Yeah, that's correct. Yeah. So yes, so the topic is, it has nothing to do with Australia. It has to do with our expansion in Middle East and Africa. You may remember in Q2, Frederick and Richard mentioned that we obtained a price and reimbursement in Kuwait. And we were able to supply the first order into Kuwait. So that's why we had 93. Sorry, we had 104. In Q3, Federic has shared with all of us that we have been able to obtain Saudi energy, price and investment, but the orders for those countries, they have not been delivered in Q3. They are in progress. So that's why you see this facing that from our point of view as a company is normal when we are expanding into Middle East and Africa region.

Okay, great. Thank you. And my final question was just, I'm a bit curious if you can give any more details on the rollout in the UK, which is going very well at the moment, I'm hearing. So I just wanted to get some more color on the sales momentum in the UK. If that's okay, thank you.

Yes, I mean, we had, as Richard here, we had a strong quarter in the UK and that is because the money is now making its way into the frontline treatment services from the government initiative. It's initially focused in some key target areas of which, off the top of my head, I think there's about 100, where that would be focused. And as that continues to go, we have the more opportunity of patients being initiated on to move it out.

And also, I think we have seen very good feedback in the UK market across the board. So it's a combination, of course, of Great feedback, but also that we are seeing allocation of money coming through.

Okay, great. Thank you very much.

Thank you. Currently, we have one further question in the queue. So just as a reminder to participants, if you do wish to ask a question, please dial 01 on your telephone keypads now. The next person in the queue is Peter Ostling of Pareto Securities. Please go ahead. Your line is open.

Yes, thank you for taking my question. A couple of ones, some of them quite short. Just referring to the increased guidance that implies around that Q4 will be around either minus 13 to plus 17 in Can you just describe what the moving pieces will be that makes you ending up in the low or high range of your guidance?

Thanks a lot, Peter, for your question. The main leverage is the progress or acceleration in our R&D pipeline. As we have explained a few minutes ago, Our main programs are based on milestones, and the earlier we can reach those milestones, the earlier we will have the triggering event, and as a consequence, we will need to put a milestone in our books. That's the main reason behind it.

Okay, so the previous guidance for R&D of around half a billion, that could be pushed out into early 2023 instead, some of those protocols?

Yes, I mean, keep in mind, we are talking about half a billion, which is a huge number. So yes, we may be talking around 480, 470. And yes, it will be a pure facing topic. So that's right.

Okay. And just two quick ones on CAM 2043. You seem to go... along with that, keeping that project. And I was just wondering, the next one that you will do in Reynolds, will that be a similar size kind of study as the first one? And also, what is your plan within the larger indication, pulmonary arterial hypertension? Thank you.

Good question. What we are looking at is a smaller study to resolve a couple of outstanding questions relating to repeat dosing and exposure. So it would be an intermediate study exploring those details. that study can be started relatively quickly. And it will also be the foundation for a possible decision for the pulmonary arterial hypertension, the indication.

Okay. Are you still talking about the new study for Raynaud's? also form the basis for if you will go along with yes i mean it's a new study for cam 2043 yes that's correct okay and and finally in the sorrento study in the control arm is there any risk that in the readout if you get an unbalanced between somatoline and It seems like that somatoline is a little bit efficacious than sandostatin if you go through the literature. Could there be a risk if there is an imbalance in the control arm that you may have more difficulty to reach your primary endpoint?

Well, I mean, we are, of course, you know, stratifying for a number of different parameters. So that will be looked into. I think, you know, which product is most efficient in this case? I think if you talk to experts, I don't think there is any clear idea. But we feel comfortable that, I mean, when we started the study, we were, of course... looking also to the prospect of quite a number of patients would end up in the somatoline arm so i think that was part of our original uh hypothesis here around the study and and also the plants but i mean there's no guarantees in in these type of studies but we feel you know through our different interactions with both statisticians and and the clinical community We feel that the design is likely to result in a positive outcome. But that remains to be seen. Okay. Okay. Great. Thank you.

Thank you. And we've had one further person join the queue. It's a follow-up from Susanna Kwekborna of Handelsbank. Please go ahead.

Hello. I have one follow-up question on the European growth VCX suite. can you give me a breakdown of, uh, what countries are contributing and to what extent, and maybe also in terms of, um, large, larger or, um, institutional customers versus, uh, smaller customers.

Thank you. Yeah, sure. So, um, um, In Q3, obviously, we were impacted by the holiday period in some markets, some more than others. We had good growth in the larger markets in UK and in Germany in the quarter, as we're seeing better access and better penetration into those markets. Sorry, was there a second part of the question, Susanna? Did I miss?

Yes, I wanted a proportion of how much each of these countries is contributing as they speak.

I don't think we've given that granularity.

Okay.

Thank you. And currently there are no further questions from the phone lines at this time. So I'll hand back to our speakers.

Okay. It was a pleasure to, to have you all listening into this call today. Thank you again for your interest. And thank, I wish you all a very nice day and welcome back to our Q4 call on the 14th of February. It will be an exciting day. So thank you very much.