Camurus Ab

Good afternoon, everyone. Welcome to CAMUR's first quarter presentation in 2021. It's been a good quarter. We'll go to the next slide, please. And of course, as always, we have forward-looking statements in this presentation. So please read them at your own leisure. I have some technical difficulties here. So, sorry about that. They are now solved. The agenda for today includes a summary of CAMER's first quarter financial and operational results that will be followed by an update about the commercialization of Bovidal and progress of key pipeline programs. And as previously, we will finish off with some key takeaways, followed by a Q&A session. With me on the call today, I have our chief financial officer, Eva Pinotti Lindqvist, and chief commercial officer, Richard Jameson. So let's move to slide number four, an overview of the first quarter results. In the first quarter we continued to make significant progress on key priorities. We had a strong commercial development and progress with Ebuvidal. We continue to expand our commercial platform in Europe and Australia with investments in Spain, France, Benelux and Switzerland. We successfully progressed our lifecycle management activities for Buvidal and received new regulatory approvals as well as patents. And we continued to build the evidence base for the treatment in different treatment settings. We also made good R&D progress with the ongoing phase 3 studies in Acromegaly A phase FDA safe-to-proceed letter was issued for our phase three study in neuroendocrine tumors. I'll come back to that later. And also, we had a scientific advice with the FDA on our polycystic liver disease program. In addition to that, we also had good progress in the early phase development, as well as our partnerships and R&D collaborations. Our financial performance continued to be positive, with a continued strong revenue growth and improved financial results, ending up in a robust cash position. The full-year financial outlook could therefore be left unchanged. And with that I'll move to the next slide, showing the development, and as you can see, in the figure on the left side, our total first quarter revenues have increased strongly since the first launch of Bluedal in 2019. Compared to the first quarter in 2020, our total revenues increased by 155% to 126 million SEK, while our operating expenses increased by 16% to 136 million SEK. This resulted in an operating result overall of minus 26 million compared to minus 77 million in 2020. I want to raise a finger of caution on this note just for you to know that of course our R&D expenses are likely to increase over the rest of the year because of the start of phase three programs as well as other clinical activities. Nevertheless, we have finished the first quarter with a healthy cash position of 428 million SEK and we're maintaining our full year financial outlook that we presented in the fourth quarter report on the 11th February 2021. With it, Short introduction, I will now hand over to Richard for an update on Buvidal. And that is then on slide number six. Thank you. Please take over, Richard.

Thanks, Fredrik. So yeah, just confirmed slide six. And this is just a quick reminder about Buvidal, our flexible weekly and monthly subcutaneous group of morphine for the treatment of opioid dependence. It's an innovative product that provides significant benefits to patient society. Our strong evidence base has demonstrated both treatment outcomes, improved treatment outcomes and patient satisfaction. We've shown a reduced burden of treatment and improved quality of life for patients and addressed many of the other limitations of the current daily treatments and the costs associated with those. We hear many patient stories like the one on the right from Justin, a patient in Australia. who talks in our annual report about how Uvidal has helped him support him in a way out of the cycle of addiction that he didn't have with the daily treatments. So if we move on to slide seven and talk a bit about opioid dependence during the pandemic, the pandemic has undoubtedly had a significant impact and exacerbated the global health crisis. And this can be demonstrated on the graph on the left. side of the slide showing the serious issue with escalating overdose deaths, in this case from the US, and this really emphasized the need for better access to care and new treatment alternatives. I think it's widely accepted now that investment in treatment brings substantial value to society and to patients, of course, and this growing crisis is being recognized through increasing commitment from governments as they tackle these challenges. As examples, there are two cases here that demonstrate the significant investments being made. One, the large £1.5 billion commitment from the Biden government that they're making specifically in the US for substance abuse prevention and treatment as part of the American Rescue Plan Act. As another example, the Scottish government pledging £250 million to address the rising drug-related deaths And as part of this policy, they directly recognize the role long-acting brutanolping can play in this response. So this brings us on to the performance of Buvedal. So please move on to slide eight and our launches across EU and Australia. Despite the very challenging period, in Q1, we've successfully continued to build access and penetration into our launch markets, resulting in strong growth with sales up 156% versus previous year and 20% on the previous quarter. We have exceptional market penetration in Australia and the Nordics after just two years, and are making good progress in UK, Germany, alongside the smaller markets. This is a strong performance in light of the pandemic, which remains a barrier for uptake and has limited our face-to-face access with clinics, though our teams continue to engage with healthcare professionals and other stakeholders through virtual platforms where necessary. With an estimated 18,000 patients in treatment now at the end of the quarter, we continue to receive clear confirmation of the value and benefits Buvedal brings. The importance of the flexibility to match patients' needs is clear alongside the opportunity to individualize treatment for patients across treatment settings from underserved populations such as the homeless through to those more stable in treatment. We continue to expand access to Buvedal and it's now available in 15 countries across Europe, Australia and the MENA region. And we're progressing at further rate launches in wave three markets during 2021. And if we can move to slide nine, please, I can give an update on those. So in the Netherlands and Switzerland, we're in the very final stages of the reimbursement process and plan to launch as soon as possible. in france we had a very positive outcome from the assessment by the has so we're now accelerating the first phase of the launch in q3 in portugal we await the outcome on our reimbursement dossier which has been glazed by the authority due to the pandemic though this is anticipated soon in croatia and slovenia we've made reimbursement reimbursement submissions which are undergoing the country processes and we're on track for launching q3 and we continue to work with our partners in the MENA region with early access programs and regulatory submissions across that area. In New Zealand, we received marketing authorization as part of our good geographical expansion and lifecycle management strategy. On that point, I'll hand back to Frederick for an update on that as we move to slide 10. So, Frederick, back to you.

Thank you, Richard. And over to a brief time-to-time update. We are now on slide number 10 here. So where we will start actually with the regulatory update on Bruvidal and Bricsady in the US and the rest of the world, and also discuss our late stage clinical programs with a focus on CAM 2029. So over to slide 11. As I said, we had a very successful quarter for our regulatory team where we received regulatory approval for Buvidal in New Zealand. We also received a positive opinion from the CHMP for approval of a new 160 milligram monthly dose of Buvidal. adding further to the flexibility for treatment providers and patients with regards to individualizing doses according to patients needs after the quarter we also got an approval for the 160 milligram dose and also aligned the label in Australia with the EU label, allowing direct initiation with Buvilal Weekly without the need for stabilization on daily sublingual therapy first. In addition, a number of regulatory submissions have been processed or prepared in different regions during the quarter. and we are expecting to see the first regulatory approvals coming through after the summer in MENA. In the US, following the December 2020 complete response letter, our partner, Braeburn, has been working closely with their manufacturer and also in close contact with the FDA to address and tackle the CRL issues. And we continue to expect a PDUFA date and approval sometime in the second quarter this year. We also was granted a new US patent for Duvidal, extending the patent lifetime for the weekly formulation to July 2032. Finally, our team is preparing for a market authorization application submission to the EMA for the chronic pain uh indication with an expected submission towards the end of the year so with that over to slide number 10 slide number 12 and an update about the clinical program for our oxidized subcutaneous depots Before going into this, as I mentioned, CAM2029 is designed with the aim to provide enhanced efficacy and improved treatment convenience for patients with rare and chronic disorders, including acromegaly and neuroendocrine tumors. Over to slide number 13. We have an extensive clinical program going with CAM2029. including currently two ongoing studies for acromegaly, and as you will see later on, starting up in NET and polycystic liver disease. Recruitment in our acromegaly study has been impacted by COVID-19, but it's accelerating as more and more clinical sites are opening up. And overall, we expect delays to be limited. We will now move to slide 14 for more details on these development programs. So, as I mentioned, we have two ongoing Phase III studies in ACRIMAG-LA, a six-month placebo-controlled randomized controlled trial, and a 12-month long-term safety study. These remain on track for NDA and MAA submissions in late 2022, And we have initiated early pre-launch activities as well in this area. During the quarter, we received a safe to proceed letter from the FDA, allowing us to start a third phase three study of CAMP2029 to assess the superiority of CAMP2029 in treatment of neuroendocrine tumors. And following the FDA acceptance, this study is now being started. we also completed a scientific advice with the fda regarding the clinical development in polycystic liver disease dld and based on the constructive and positive feedback from the agency we are now developing the last part of the patient reported outcome measures which will be an important end point in this study and finalizing the protocol development of feliz 2 free clinical study which we plan to launch in the second half of this year. Finally, there's a lot of ongoing activities in 2029. We are conducting a pharmacokinetic study where we are comparing the data using our pre-filled syringe configuration that we have used in previous studies with a new autoinjector device, or as it will be referred to, a pre-filled pen format. This study has progressed well and we are expecting all patients to be completing treatment in the single dose part of the study during this quarter. The pre-filled PEN device will be fully validated for clinical and commercial use in July this year and will be introduced also into two of the phase three studies. We believe that this will be a further important differentiator for CAM2029 in the clinical setting, and we greatly simplify administration and improve convenience for patients. So with that summary, let's move over to the news flow on slide 15. So here you can see an overview of expected news flow during the coming year. We are in the final stages of the Buvidal line extension approvals in Australia and Europe, where we are only waiting for the European Commission to give a formal approval for the 160 milligram dose. And we are also on track to deliver the remaining milestones in the first half of the year. In the second half of 2021, we are looking forward to updating on the progress of our clinical programs, as I mentioned. And also, we are waiting for the start of the registration program of the weekly set melanotype product that is developed by Rhythm based on our technology, as well as phase two results for CAM2043 in Raynaud's syndrome. And importantly, of course, we are looking forward to the anticipated US approval of BRICS-ADI. Moving over to slide 16, we are completing this presentation. Now on my final slide, we have outlined our key strategies for value creation, both in the short and medium term. On the commercial and development side, Camrys is already the market leader with Buvidal in a few markets, and we will continue to build our leading position in Europe and Australia and expand into new markets during the coming years. In addition to that, we are looking forward to the US approval, as I mentioned earlier, and through that, potentially becoming a leading global brand in the opioid dependence treatment area. We have also begun our diversification on the commercial side with pre-launch activities, both in the chronic pain and acromegaly area. And we will continue investment in our R&D and pipeline development with the goal to obtain both new regulatory approvals for CAM 2038 and CAM 2029, but also grow our portfolio of innovative medicines in other areas of high unmet need and market potential. On the corporate side, we will continue building and expanding our commercial platform, where we have done excellent work up to now, and add new products. And of course, we're targeting to develop sustained growth over the next few years and also profitability. I look forward to reporting on these further steps of our journey in the next quarterly call on the 17th of July. So with that said, now it is a good time for the question and answer session and I will hand over to the call to the operator. So thank you everybody for listening.

If you do wish to ask a question, please press 01 on your telephone keypad. If you wish to withdraw your question, you may do so by pressing 02 to cancel. Our first question comes from the line of Peter Sehested from Handels Banking. Please go ahead, your line is open.

Hi, Peter from Heather Banking. And let me start by apologizing for the fact that I wrote in my first comment that your revenues were up by 75%. That is, of course, 75 million kroner, but up by 155. So if the share is down for that reason, well, I can only urge to go up and exploit the market efficiency and buy some. But nevertheless, these comments aside, of course, the market is highly interested in knowing about them. um about the progress with quickside in the u.s you do make some comments in the in the in the report but can you say a little bit more on top of what is already mentioned in the in the report thank you very much well yeah what i can say is that there is a good dialogue with the agency and

As I understand it, everything is progressing according to plan in terms of the response and sorting out the issues that have been raised. I do believe there is quite a lot of pressure, if I look at it from the outside, on the agency at this time, but our expectations remain the same. I would also like to say that, of course, there is still a tentative approval for Brickside in the U.S. So the further approval is, of course, just a matter of sorting out this complete response letter, and other issues should be non-controversial. So we are still expecting the approval to come in the second half of the year, unless something completely

different comes in terms of signals but that's our standing now all right have you any way um have you any measures of um of contacting the um the manufacturer uh themselves and finding out you know what's the actual status on uh and and progress that they are making to rectify those issues that were raised by the by the fda

I mean we are bound by confidentiality here and to the extent we know anything, I think that what is clear is that every effort is, this is of course a very important development for all parties involved and every effort is put here. We also know, you know, and we have had a third party looking into the questions that were raised in the CRL, so that is public domain information. And we, in our own interpretation of those, consider them to be addressable within between one and four months. So we are expecting things to move forward, but I don't have any further details from this development that I can communicate now.

All right. I'll jump back out of the queue. Thank you very much. I'll jump back out of the queue and come back later.

Thank you. Thank you. I remind you that if you do wish to ask a question, please press 01 on your telephone keypad. If you wish to withdraw your question, you may do so by pressing 02 to cancel. There will now be a brief pause while questions are being registered. And there are no further questions at this moment, so I'll hand back to the speakers.

Okay. With that said, I think I just want to thank everybody for listening in to our call. It's always an important point of the year to be able to deliver the results of the quarter. And I think I want to especially thank my team for producing such a great result. and all listening in for taking the time to listen to cameras and i look forward to following up on the q2 call in july until then hopefully meet you in other circumstances and have a great afternoon everybody