Camurus Ab

Thank you so much, and hello everybody from hot and sunny Sweden. And welcome to Canberra's second quarter and half-year results presentation, where we will give an update on our financial and business progress. Before we begin, please be aware that the presentation contains forward-looking statements, which are subject to risks, uncertainties, and different assumptions. Slide three, please. So our agenda today includes an update on strategic objectives, an overview of CAMERA's second quarter and first half year results, commercial development by Richard, and a short update on R&D and the progress in our key pipeline programs. As usually, we will finish up with some key takeaways, followed by a Q&A. With me today is our CFO, Eva Pinotti Lindqvist, and Chief Commercial Officer Richard Jameson. So before going into the results, I will give a quick recap of our mid- to long-term strategic objectives. Slide four, please. It is now a little bit over two years since Camry started the journey as a commercial company through the launch of Buvidal in the initial European markets. As you see, we have come a long way since then in our efforts to improve access to treatment and establish Buvidal as the leader in opioid-dependent treatment. In parallel, we have made significant progress towards bringing new innovative medicines to the market to build and diversify our business. Going forward, we will continue to grow our pipeline through patient-centric innovation collaborations and acquisitions of commercially attractive and complementary assets in strategic areas. These include addiction, endocrinology, oncology and chronic pain. Finally and importantly, we will continue to build our commercial infrastructure, drive operational execution excellence with the aim to deliver sustainable profits from 2022. With that said, let's look at our achievements and results in the second quarter and first half year. Slide five, please. In the second quarter, we continue to deliver strong operational performance despite the impact of the pandemic. This is really the credit to the commitment and resilience of our teams, which are doing really a terrific job on our markets. We have executed on our commercial objectives with a robust revenue growth in challenging market conditions. We have had several progress in the lifecycle management and achieved new approvals and published compelling clinical results for Bovidal in leading peer-reviewed journals. Importantly, we continue to experience a strong interest in and a demand for Buvidal in all markets, and we are steadily improving access. Our pipeline has progressed well during the quarter with highlights including the FDA acceptance of Braeburn's NDA for Bricsari with the PDUFA date of 15 December 2021. We advanced our registration programs in acromegaly, neuroendocrine tumors, and polycystic liver disease, as well as the early pipeline and partnerships. Our financial development continued in a positive direction. Quarterly revenues increased to 138 million SEK and half-year revenues were 264 million despite the conditions that have prevailed during this first half-year. The operating loss in the quarter was 60 million which is higher than the previous quarter and previous year due to high activity in our ongoing phase three programs. So we ended the period with a solid cash position of 422 million SEK, which is a strong base for executing on our strategic and commercial objectives. With that said, let's move to slide six for a closer look at our financial development. So as you can see here, revenues continue to grow well in the year. And I've already mentioned the pressure of the pandemic, which has prevailed. In the second quarter, second half of the year, we experienced increased growth of product sales and total revenues. as conditions in the markets develop. Operating expenses have increased in the last quarter from a stable base in 2019 and 2020, and this really reflects the progress of our phase 3 programs. Overall, we see a positive trend towards profitability, which we expect to reach in 2022, as I said before, without the contribution of milestone payments from the US. Finally, our full year guidance is maintained based on the predicted growth in the second half of the year as the impacts of COVID-19 continue to wane. With this brief overview, I'll hand over to Richard now for a commercial update. Slide seven, please.

Great, thank you, Frederick. Good morning, good afternoon, everybody. In the next few slides, I'll give you an update about the commercial progress of Bovedal, our flexible weekly and monthly long-acting group at Nortine. I'll focus on an update on sales, and we'll share with you some of the growing support and opportunities we see in our markets as we build patient access, driven by the significant benefits Bovedal brings to patients and society, which are becoming increasingly recognised across stakeholder groups. So if we could move to slide eight, please. So starting with Bhuvana sales, they've continued to develop well, particularly in countries spared from the restrictions of COVID. However, some markets were impacted by the pandemic where lockdowns restricted our access to healthcare professionals and many patients were not accessing clinics. And this, of course, limited opportunities for new patient starts during the quarter. Currently, we have about 19,000 patients in treatment with Buvidar at the end of the quarter, a patient share of about 5% in our current markets. In those markets where we've addressed hurdles, we do see significant penetration. In Finland, as an example, we have clear market leader status now with 60% share of the total patient population now treated with Buvidar. And in Australia and Scandinavia, we've rapidly moved beyond double-digit market share all within two to two and a half years of launch. And we have a very strong position in Australia, which is the market where the two injectable buprenorphines are available. In other launch markets, our penetration is slower, but there's also a strong demand for Buvidal, and we continue to make good progress. And we're getting share as we move those access hurdles patients are facing and release funding for treatment. I will cover some examples of this later on. There's significant potential remaining in these countries with about 300,000 patients in treatment for opioid dependence. We're also prepared for further expansion with planned launches in a further seven new markets, which will also represent a large opportunity for Buvedal with more than 200,000 patients in treatment. We're in the final stages of the pricing and reimbursement processes, and whilst these have seen some temporary delays due to the understandable focus of health authorities in managing the pandemic, we do expect launches in Q3 and Q4. And we've received wide support and collaboration from key opinion leaders, who are eager to have Boobedale available and are supporting our applications. Furthermore, we continue to work closely with our partner Newbridge in the MENA region, preparing for both regulatory approvals and launches in several countries. The positive feedback received daily from clinics, alongside the growing evidence base for real-world reports of the impact Buvidal is having on patients and the treatment system, is creating growing awareness and increasing the support for patient access to Buvidal across our markets. Action is being taken by government, policy makers, healthcare professionals and patient advocacy groups to address the patient access. So moving to slide nine, if we can, I can share some of these. Firstly, several government initiatives have been announced during the quarter which will accelerate a patient access. With examples in Scotland, the Minister for Drugs announced in the Parliament new increased funding specifically for Buvedal alongside other investments in treatment. likewise we've seen additional funds become available for long-acting treatment from public health england as part of an additional funding stream for harm reduction measures and again in england an independent review for treatment of substance misuse sponsored by the government has been completed with a clear recommendation for significant investment over the next five years and the recommendation is for an additional 552 million pounds which by year five and if approved, will double the current expenditure. We believe this will allow accelerated access to innovative treatments. Processes are also ongoing in Germany and Sweden to improve the healthcare professional remuneration system, which has some restrictions on access. The criminal justice system is also a key focus for us, with an estimated 100,000 patients in treatment at any time in prisons, and of course, many patients passing through the criminal justice system. Reports and publications from Australia, Germany and Scotland, the forerunners in this area, have clearly shown the benefits of Buvidal in this setting. And I think a quote from the research report recently published by the Scottish Government on their experience with a large cohort of patients, its reference on the slide here, is compelling. At its date, and I quote, high levels of satisfaction about Buvidal were reported by almost all patients. And health care staff continue to be enthusiastic about the positive impact Buvedal can have on patients' lives. So these reports, alongside new published evidence and health economic analysis and real world experience, that show the value promise of Buvedal are creating significant media attention. And as you can see with some examples on the left hand side, where Buvedal is in the media often described as a life changer or game changer. And I don't think in my 30 years in the industry, I've worked with a product that self-generates so many positive media reports and patient cases histories. So if we can go back to the published evidence, then moving on to slide 10. As mentioned earlier, in Q2, we grew our scientific evidence base with two new important publications. And you can see the titles on the left-hand side here. The first, the DEPU study. that demonstrated superiority in patient-reported outcomes with buvidal compared to sublingual buprenorphine naloxone was published in JAMA Open Network alongside an editorial by Nora Volkow, the head of the National Institute of Drug Abuse in the US, where she recognized the importance of PROs as an outcome in opioid dependence and also the value of this study. The second study, the UNLOCK-T study, demonstrated the utility of buvidal in custodial settings and the advantage it brings over existing treatments. We continue to share our evidence-based and real-world experience through many scientific congresses. Many of these have been pushed to the second half of the year. Now we see easing up of the restrictions from COVID. And these are alongside presentations at local meetings and webinars. So with that overview on the progress and significant opportunities for Buvidal, please move to slide 11 and I hand back to Fredrik.

Thank you, Richard. And let's move over to an update on the progress of our pipeline where I will start with the lifecycle management side and market approval processes for Buvidal and Bricsadi and then move over to the progress of our clinical programs. During So, next slide. During the second quarter, we received market approvals for a new, higher 160 mg Boogadal dose in Australia, the EU and the UK. Further extending the dose options for patients needing higher than the highest labeled 24 mg sublingual dose, which we estimate is around 10% of patients, depending on market. We now have a full range of individual weekly and monthly doses covering the patient's individual needs. And this is of course very significant progress. A further positive development in the quarter was the approval of a label extension in Australia allowing for direct initiation of patients on Duvidal. So they don't need to be treated on sublingual buprenorphine prior to treatment with Duvidal anymore. And this is now harmonized with the EU label which had this included priorly. Right now, our regulatory team is also busy preparing for the planned submission of a market authorization application for Buvidal and CAM 2038 in chronic pain, which is scheduled for later this year with a possible approval in the second half of 2022. As Richard said, we have a lot of things going on in MENA as well, where we currently have four market authorization applications under review and additional applications on track for submission. Meanwhile, early access programs are ongoing in the three countries, in three of those countries, with currently a few hundred patients being treated with Buvidal. The market, however, is very substantial. In the US, we got the positive news from our licensed partner, Braver, that all complete response letter issues had been resolved and that the NDA for Brixadi had been submitted to the US FDA. This NDA submission was quickly accepted by the agency with a target approval date, as I said earlier, in December. Greyburn is now preparing for the launch and we look forward to US patients finally getting access to a new and effective treatment option in the form of Brixadi. Slide 13, please. To put the potential approval of BricsID in context, it is worth looking at the current state of the opioid crisis in the US. Sadly, and it's also recognized in several news articles today and yesterday, this has continued to escalate during the COVID-19 pandemic, with a provisional number of annual overdose opioid deaths now exceeding 60,000 per year. which is a horrendous figure, and overall drug deaths reaching the tragic mark of 90,000 per year. 10 million Americans are estimated to misuse opioids each year, and approximately 2 million are currently diagnosed with opioid use disorder. Of these, about 1.4 million are in medication-assisted treatment programs, and 1 million are receiving treatment with buprenorphine. There is undoubtedly a large need for treatment options in the US, as illustrated by the announcement of the Biden administration of a $1.5 billion investment to tackle the opioid crisis. Many other measures are taken to address the crisis, including increasing the number of healthcare professionals with a waiver to prescribe and administer medication-assisted treatment. Next slide, slide 14, please. So looking at the market dynamics for long-acting injectables in the US, we see that the US market for opioid use disorder drugs is currently about 2 million US dollars. This is expected to grow to more than 3 billion US dollars by 2028, driven by long-acting injectables and new patients entering treatment. The patient shares on long-acting injectables in the US is however still low, corresponding roughly to about 3% of total patients in treatment. Yet the market size for long-acting injectables is approaching 500 million dollars per year with a difference with a highly differentiated profile and a strong and growing evidence evidence base we expect brixari to be an attractive treatment option for healthcare professionals and patients with opioid use disorder in the us we believe that the market entry of society will have a positive add-on effect on the lai market contributing to faster growth and more patients switching from daily medication to weekly and monthly treatment options. Already, we know that through investigator-initiated programs, there are more than 1,000 patients in treatment with Vixadi, and the total number that will come into treatment through these programs will be 2,000 patients. So looking at new interesting applications of this product in the marketplace and in the treatment place. More details about the commercial plans and market expectations for Bricside in the U.S. will be provided closer to launch. So let's move to the next slide, 15, and an update about the ongoing phase three programs for CAMP 2029. So CAM2029 is our innovative subcutaneous depot of octreotide, currently under development for treatment of acromegaly, neuroendocrine tumors, and polycystic liver disease. The product is designed both for enhancing the efficacy, but also significantly improving treatment convenience for patients compared to currently available treatment alternatives. Next slide, slide 16, please. So we have a large clinical program ongoing to document safety and efficacy of CAM-2029 across three orphan indications, as I mentioned before. This program includes a phase three efficacy study, DIVOCAL, and a long-term safety study in acromegaly involving more than 50 clinics, clinical sites in Europe and the US. and scheduled to report top-line results during 2022, followed by regulatory submissions. This study is also complemented by an ongoing phase one study of pharmacokinetics, pharmacodynamics and tolerability, designed to be a bridge between our current pre-filled syringe device and the newly developed injection pen, which will be fully validated for commercial use this quarter. The key randomized single dose part of this study is being finalized, and results are expected later this year. This is then being followed, or already being followed, by a multiple dosing part to bridge between different subcutaneous injection sites at steady state. We're currently planning for flexibility and having both dosing options included in our regulatory submissions and preparing for commercial manufacturing is well underway. The second indication for Cali2029 is GetNet, get through and through pancreatic neuroendocrine tumors, where we during the quarter have completed preparations for starting recruitment and expect to have the first patients entering the study after the summer vacations. This is a randomized double-blind study design where we have the aim to show superiority in progression-free survival, PFS, with CAM-2029 versus current treatment standards. with Sandostatin-LAR and Somatulin-Alzegel, which are both first-generation somatostatin analogues. We have large interest for participation in this trial and expect to complete patient re-enrollment during 2022 and complete the study in the second half of 2024. We're also in the process of starting a Phase 2-3 study in a third indication, polycystic liver disease, for which there is no current treatment approved. This follows discussions with the leading key opinion leaders in this area and the Type B meeting held with the FDA earlier this year. As a part of the preparation for starting the study, we're also developing a new patient-reported outcomes tool, which is under finalization and will be used in the clinical study as a complement to the primary measure of liver volumes. The studies plan to start in the fourth quarter. Next slide, please. So here is a short summary of what is going on in the different programs. And on the right hand side are our peak sales projection for CAM 2029 based on third party primary and secondary research by indication. As you can see, CAM 2029 represents a very sizable opportunity with total peak sales of around or above 1 billion US. So going from that, let's go to slide 18, please. So with this short update on CAM 2029, I'll move over to our recent anticipated news flow. We have delivered on the first half year objectives, as you can see, and entering into the second half of the year, we're expecting a number of important milestones, including from our clinical programs for CAM 2029 and 2043. We're also expecting to see the start of Rhythm's phase 3 program for the weekly set melanotype product that we have developed together for treatment of genetic obesity disease. The submission of the market authorization application for CAM2038 in chronic pain is, of course, a further milestone, as is maybe Most importantly today, the potential for an NDA approval of BRICS-ADI that we are expecting to come towards the end of the year. Next slide, please. So now to my final slide here and some takeaways from the second quarter. and which i think has been a very strong quarter from our from our side from an operational perspective and also commercially in the parent or during the conditions that prevailed on the commercial side we continued to deliver significant sales growth under these challenging conditions and buvidal is now the market leader in the nordics and australia in terms of of sales of individual products. We have successfully completed lifecycle management for Byggdahl with new regulatory approvals in Australia, the EU and the UK. We have further strengthened the evidence base for use in communications with healthcare professionals and budget holders. We also saw important new funding initiatives and also new decisions in this area. We also continue to advance the product pipeline with the potential for EU approval or for US approval of Bricsati. Our phase three programs advanced, and we have also seen significant progress in our early pipeline and partnerships. On the corporate side, we have established a strong base for executing on our strategy for sustainable growth and profitability in 2022. and beyond this I think we also have other things of large interest to come. With that said however, we conclude this presentation and I hand over the call to the operator to initiate the Q&A.

Thank you. 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 Once again, that is 01 on your telephone keypad to register for a question. And there will be brief pause whilst any questions are being registered. And our first question comes from the line of Harry Sefton from Jefferies. Please go ahead. Your line is now open.

Brilliant. Hi there. Thanks for taking my questions. My first one will be on... the competition that you've been experiencing from Indivio's long acting Subutex in your markets. Can you maybe comment on whether you've seen any intense competition, which might have led to a slight weakening of the growth rate quarter on quarter?

Well, I think one thing I think, I mean, we are of course not viewing product as competitive, but add-on and I think it's important for patients to have the choice here. So that is a clear point. That said, we have had continued strong growth and we have not seen the pressure from other treatments on the growth projections or the actual growth, no.

Okay, brilliant. That's very helpful. And then maybe just to comment on the points you made around the COVID disruption. So I think at the start of the pandemic, it seemed that you were more benefiting from restrictions and that it favoured the transfer of patients onto Buvidal given the reduced interaction with the product. You've now highlighted that COVID is limiting the patient uptake. Can you maybe talk through how these contrasting dynamics have changed over time?

Yeah, I can talk about that, and then I'll leave over to Richard for any add-on comments. But what happened in the first half of last year was, I think, a combination of the fact that we had established a robust base of patients there, but also when COVID came, I think there was a build-up in hospitals, et cetera, of stock that perhaps was not to the extent we understood it in market sales, but there was definitely a build-up relating to, and we have heard that from other companies that had similar dynamics going on. Then I think quickly that the impact of COVID was not recognized to the same extent. So we had the base and then going into the second half of the year, we really saw a pickup in terms of increasing number of patients during the entire autumn last year. And then came the second wave in the first part of this year. And a lot of our different markets have been almost shut down. I mean, I know, for instance, it's been extremely difficult to have any interactions with healthcare professionals in Germany. We have had the criminal justice system not allowing for digital meetings, so it's been very challenging to have uptake there. And other markets, such as Norway, same thing. There was essentially no face-to-face meetings. So it's a gradient from markets that were slightly affected to some that were very heavily affected by the situation and where we didn't have access to healthcare professionals. In addition to that, I know that in some markets they prioritized administration of vaccines. So we saw that adding on to the issues we had in Germany, for instance, where GPs were also prioritizing giving, and rightly so perhaps, giving vaccine injections. So there's multiple factors. Richard, do you have anything you want to add to that?

No, I think you've covered it, Frederik. That's very helpful, Kalle. Maybe just quickly on the BRICS-ADI resubmission. As you've highlighted before, there was quite a comprehensive list of items on the FDA 483 letter. Just want to get your thoughts on how satisfied you are that all of those issues have been addressed.

Well, I mean, the fact that the FDA accepted the application means that they have been provided with a complete response. So I think we have to take that for satisfactory.

Brilliant. And then maybe just quickly on the CAM 2029 phase three for neuroendocrine tumors. You said that you expect patients to enroll by the end of the summer. Would you say that as a result you're expecting a second half waiting for R&D costs this year so we can see quite big pick up in potentially the late third quarter and in the fourth quarter?

Well we have had of course you know in the startup phase there are significant costs coming in when you're starting up with phase three studies. So our projection is that we will We have established, at least for the coming quarters, a reasonable stable level. Eva, do you want to say something on that?

I agree. There are some significant thoughts related to the programme. To complete this programme, I believe, we have reached the level where we will see we will end up also for the Q3 and Q4.

Brilliant. That's very helpful. That's all from me. Thanks very much.

Thank you, Harry.

Thank you.

And have a brilliant summer.

It is 01 on your telephone keypad if you would like to ask any questions. And as we do not have any more questions registered, I now hand back to our speakers.

Okay, thank you all for taking the time here in the middle of the summer to listen to our presentation. It's always... a pleasure to have the opportunity to give an update on what we are doing in the company. I wish everybody a wonderful summer and I look forward to providing you a further update in our Q3 call and meanwhile we will do our best to make everybody pleased. So thank you everybody and have a great summer. this.