Camurus Ab

Thank you so much and good day, everyone. Thanks for joining our third quarter earnings call. Next slide, please. Before starting, please note our forward-looking statements that are subject to a number of uncertainties, risks and assumptions. Please read them thoroughly. Slide three, please. So with me today on our call is our chief commercial officer, Richard Jameson. and Chief Financial Officer Eva Pinotti Lindqvist. Today's agenda includes a review of the third quarter highlights, financial results and a full year outlook, an update on the commercial development and our late-stage R&D programs. We will finish off with some key takeaways before opening up for Q&A. Next slide, please. During the third quarter, our commercial execution continued positively under the remaining pressure of the pandemic. We achieved double-digit sales growth for Buvidal for the ninth consecutive quarter, reaching 152 million second sales. The feedback from patients, healthcare professionals and policymakers continue to be very positive across all of our markets, and Buvidal is now available in 17 countries. and we are ready for launch in an additional five markets once pricing approvals are received. Our late-stage development programs have progressed towards key milestones. In the US, our partner Braeburn is waiting for the approval decision for Brixadi by the 15th December PDUFA date. In the EU, we are on track for a Q4 regulatory submission to EMA to expand the Buvidal label to include chronic pain. In addition, we advanced our ongoing Phase III studies of CAM-2029 in acromegaly and neuroendocrine tumors. We were granted orphan drug designation in the U.S. for a new indication for the treatment of polycystic liver disease. Our financial performance continued to improve during the quarter, with an increasing revenue and improved operational results We maintained a healthy cash position of 426 million SEK with no debt and a strong balance sheet. So with that, let's move over to slide number five for more details. So despite the challenges of launching new products during the pandemic, we have delivered strong sales and revenue growth since our first launch in Finland in 2019. Third quarter revenue grew by 54% year-on-year to 154 million SEK, and nine-month revenues grew by 81% to 418 million SEK. Our growth peaks increased by 37% year-on-year to 454 million SEK as a result of our increasing Phase 3 activities. Despite the increasing investments into R&D, our operating results in the third quarter improved by 73% to minus 6 million SEK only, and by 25% to minus 94 million SEK year-to-date. So overall, we have a positive development and positive trend towards profitability, which we plan to reach within the next year. Slide six, please. However, as you've probably seen in our Q3 report published this morning, we have revised our 2021 full-year guidance. The pandemic has continued to affect our business. It has restricted direct contact with healthcare professionals and other stakeholders and resulted in prolonged delays of the pricing and reimbursement processes. which has, of course, impacted on revenue growth and postponed launches in several countries. As a consequence, we have lowered our full-year guidance for product sales to between 575 and 595 million SEK, and total revenues to between 600 and 630 million SEK. The updated intervals correspond to a year-on-year growth of between 78 and 88%. For the full year operating results, we guide to the lower end of the previous interval, minus 120 to minus 105 million SEK. We see this importantly as a short-term adjustment, and it does not affect our positive view on growth in 2022 or our long-term goals. So with that, Richard will now move over to give an update about the progress in the commercial development during the quarter. Over to you, Richard.

Thank you, Frederick. We are now on slide eight. As Frederick said, in Q3, we had our ninth consecutive quarter with double-digit growth and continued to build a number of patients in treatment, with an estimated 21,000 people now in treatment with Buvidal. In markets where we've already successfully addressed funding and access, we see rapid and high penetration with market shares in Australia, Scandinavia, Wales, and Scotland between 10% and 20%. In Finland, we achieved even higher penetration, and to remind you that we have over 60% of all patients in treatment with Buvadel now. This success reflects the positive profile of the product and the need for new and improved treatment options. In larger markets such as UK and Germany, we start to see accelerated growth as the funding and remuneration barriers are overcome. And once fully unlocked, the potential for these countries is high and we will have the opportunity to significantly grow our market penetration. This is our focus for next year. We also continued our market expansion and in the quarter launched in France. We are focused initially in clinics and prisons, which with 30% of patients represent a significant opportunity. Uvidal was also launched in Slovenia after a positive reimbursement decision. The pricing and reimbursement process in other markets has been extended and decisions delayed as authorities have focused on managing the pandemic. We have, however, continued to partner with the authorities, which has resulted us being in the final stages of approval in five new markets with launches planned for the coming months. There is continued positive feedback from both patients and healthcare professionals and important real-world evidence is being published and presented at Congresses. The growing evidence, awareness and interest among stakeholders gives confidence for accelerated growth. And whilst the pandemic has impacted in the short term, we maintain our outlook and goal to have more than 100,000 patients in treatment in 2026 in our markets. In addition comes a significant opportunity in the rest of the world. So if we move to slide nine. Now that the restrictions from COVID are waning, our teams have increased face-to-face engagement with healthcare professionals to accelerate training and offer a game-changing treatment to patients. We have a high profile at scientific meetings and congresses to share the growing evidence. As an example, at the ATHS meeting in France, both the debut and long-unlocked T-studies were presented, alongside a presentation on the experience with a COVID of more than 1,000 patients treated with buvidal in Wales. This showed that 80% of patients have moved to recovery within two to six months and also indicated a high retention for the cohorts of above 90%. In the UK at the RCGB Secure Environments Conference, a presentation which again showed that significant value of long-acting buprenorphine in a custodial setting was presented from experience in Scottish prisons. This has led to a positive report by the government and additional funding. Furthermore, we have seen continued building of evidence-based with two additional papers published in the quarter, one guiding on the transfer to buprenorphine from methadone and the other a qualitative report from patients from the debut study that described the benefits of long-acting buprenorphine for patients, including reducing stigma and giving the opportunity to engage in structured activities such as work and study. Our geographical expansion outside of EU and Australia also continues with our partners. So moving to slide 10, We are continuing with our regulatory approval in other markets. Starting with the U.S., where the country continues to face the opioid crisis with number of deaths from overdose now exceeding 70,000, there is a high unmet need for new treatment options and an estimated 10 million people misusing opioids and 2 million with diagnosed opioid use disorder. The Brixardi NDA has a Purdue for date set for 15th of December this year, and if approved, will be available to patients in early 2022. There is high interest in the product, with several large investigative sponsor studies currently ongoing. In the MENA region, we have submitted MAAs in four countries, two of which have been granted fast-track submission, and further submissions are in progress. Due to demand from local clinics, we also have pre-license sales in three countries ongoing. And finally, we're on track for the Q4 EMA submission to expand the Buvidar label to include chronic pain. So in summary, we have high penetration in established markets where funding has been addressed and they're seeing accelerated growth in larger markets in the UK and Germany and have a significant opportunity in France. These large markets are our growth drivers for next year as we break through to secure increased funding for Buvedal that will drive penetration. From here on, we'll continue to build our market leadership in our territories and continue to have a profound impact in helping patients achieve recovery. So on that note, I'll hand back to Fredrik, and we're on slide 11.

Thank you, Richard. And over to a short update on our late-stage development programs. We can move over to slide 12. As Richard already mentioned, the registration processes for Bricsady in the U.S. and preparations for EU label extension for Buvidal CAM 2038 to include chronic pain are ongoing. So I will give an update on our registration programs for CAMP 2029 and CAMP 4072. Next slide, please. So CAMP 2029 is our subcutaneous depot of osteophytes under the development for treatment of acromegaly, neuroendocrine tumors, and polycystic liver disease. The product is designed for enhanced efficacy and improved treatment convenience. aspects which are being explored and assessed in the in local phase three programs we have a large clinical program up and running for camp 2029 targeting three rare disease indications i said during the quarter treatment of patients and recruitment continued in our two phase three studies in acromegaly where additional clinical sites and countries were opened up after lockdowns Based on the current projections, we are expecting top-line efficacy and safety results during the second half of 2022. For the neuroendocrine tumor indication, we initiated the pivotal phase 3 study in the third quarter after completing preparations and having aligned the study design with FDA and EMA. Enrollment of patients has begun. and the study is expected to be fully recruited in 2022. In addition to acromegaly and the neuroendocrine tumor indications, we are also initiating a phase 2-3 study of CAMP2029 in polycystic liver disease, where there is currently no approved medical treatment. The study is planned to start early next year, following our development of a new patient-reported outcomes tool, which will be introduced in the study as a primary outcome measure. In addition to the pivotal studies, we are in the final stages of completing the bridging pharmacokinetics study for our newly developed prefilled PEM device, which is now also being introduced into the phase three studies. And this is a major improvement also of the overall profile of the product. So, moving over to slide 15, it is. Before leaving the CAM2029 development, I just want to show you a schematic overview of the design of the recently initiated phase 3 study in gastroenteropancreatic neuroendocrine tumors. This study as the first study aims to demonstrate superiority in progression pre-survival with CAM 2029 versus current standard of care. We have a large interest in the study from investigators and clinicians and are estimating to have 90 clinical types participating in the study across North America and Europe. So it's quite an impressive In addition to our own, and now we are on slide number 16, in addition to our own phase 3 programs, our partner Rhythm announced during Q3 that they intend to start two phase 3 studies for our long-acting formulations of Cetmelanotide in patients with Bartlett-Bevel syndrome, which is a rare and severe genetic obesity disease. with a lot of other symptoms. We're also looking forward to the dosing of the first patients in these studies and the prospect of having up to six clinical phase three trials running early next year in our different pipeline programs. Next slide, please. Before going to the questions and answer session, I just would like to summarize our key takeaways from the third quarter. On the commercial side, we delivered double-digit Buvedal sales growth for the ninth consecutive quarter under quite challenging market conditions. We grew the scientific and real-world evidence base and continue to receive amazing feedback on Buvedal from our markets. We expanded into new countries and saw growth starting to accelerate in the important larger markets such as UK and Germany. Here we see potential for both near-term and long-term growth. Our product pipeline continues to advance with an anticipated US approval of Bricsari in December. We have prepared the regulatory applications for a label extension for buviraltotronic pain. which will be submitted in Q4. Our registration programs for CAMP 2029 was expanded to now three rare disease indications, and we also progressed our early pipeline and partnerships. On the corporate side, we improved our results and ended the quarter with stable cash position of 426 million SEK. We are thereby financed to execute on our strategy and reach sustained profitability during 2022. On top of that, we also have the possibility of receiving important and achieving important milestone events, including the U.S. approval for Rixari, which can further bolster the financials and future prospects of cameras. So with that, I hand over the call to our operator for the Q&A.

Thank you. Ladies and gentlemen, if you wish to ask a question, please press 01 on your telephone keypad. Thank you. We have a first question from Susanna Krekbana from Handelsbanken. Madame, please go ahead.

Hello, and thank you for the presentation. I'm Susanna Krekbana from Handelsbanken, and I'd like three questions, please. Perhaps I can take them one at a time.

Yes, Susanna, welcome.

Okay, so firstly, you've stated that you're launching Buvedal in five countries during Q4. Can you talk about which countries they are, and if not, at least talk about the size in relationship to the markets that you have already launched in?

Yes, I will. I can give you a hand-waving answer to that question. So these include Benelux countries, it includes Central European countries, and it also includes the Southern European countries.

Okay.

So in terms of market size, I would say, Richard, what do you think?

Probably a region of 50,000 patients, I should think, in treatment in those markets, maybe higher actually.

So let's say that it's around 50,000 to 60,000 patients in those markets total.

Okay, thank you. And to follow up on that, do you experience differences in the launch progress? between European countries with high methadone use but low buprenorphine penetration and vice versa. What are the other dynamics at play here?

I think this is a very important question and also a very important question for our strategy going further. I mean, obviously, I think those two markets are quite separate in a sense. So the dynamics is similar for the buprenorphine patients across the world. We shouldn't say that the methadone group is equally, which is transferable, but with the event of Buberol or long-acting injections coming to the market, there is an increasing trend of switches from methadone over to buprenorphine, definitely. This is occurring on a quite frequent basis in the criminal justice system around our markets, and there's more and more interest around the different countries. So I would say that from a rapidness or from a race perspective, it is more challenging to switch patients from methadone, but with the event of these long-acting injectables coming to the market, this is going on in a much higher to a much higher degree and we we see this increasing we had a big meeting in in denmark only a couple of weeks ago where the main question was actually how they could switch the method on patients over to other treatments including pipernorphine

Yeah, I think what's different as well, we see quite a big demand from patients to come on to long-acting from methadone. They may not have gone to a daily treatment in the sublingual group, but there seems to be a desire to come on to long-acting treatment because of the benefits it confers, reducing that stigma, the burden, etc. So I think that, again, is helpful for that transfer.

Thank you. Okay. And then my third question is, you've got quite a lot of studies that are moving towards more mature stages of clinical trials. How should we think of the R&D costs in 2022? While not expecting exact guidance, help us think about the direction, not at least in light of the guided profitability for 2022. Okay.

yes i think i mean when we have this question in our last call and and we said that the level that was established in in q2 was going to be relatively representative of of you know the at least for the coming year so i think we will see an increase on on the full year of 22 But it will probably be a modest change. What do you say, Eva? Can you?

No, I agree to that, basically. Yeah, we will see an increase, but I still believe moderate, as you said.

From 2021. Susanna?

Yeah. Yes, okay.

Are you fine?

Yes, I'm fine.

Okay, so we can have another question. Ladies and gentlemen, if you have a question, please press 01 on your telephone keypad. Another question from Susanna. Please go ahead.

Okay, one last question. Lastly, does the target of profitability in 2022 require a U.S. approval of BRICS-ADI, or could you achieve that based solely on the EU and Australia sales?

Eva, please.

All right. No, it does not require U.S. approval.

We are... targeting sustainable sustainability based on our current operations.

Thank you. Thank you. No more questions. Just a reminder, ladies and gentlemen, if you wish to ask a question, please press 01 on your telephone keypad. Thank you. No more questions. Back to you for the conclusion.

Thank you for listening in today. I hope very much that we will be able to meet before our next call in January. But in the meantime, I wish you all a very nice day and a continued nice and profitable year. So thank you very much and talk to you in January.