Camurus Ab

Thank you. Thank you. Good afternoon, everyone. Welcome to our Q1 results presentation. I hope that you are all well and safe in this unprecedented time. What I think is one of our strongest reports in our history. But before going into that, I would like to forward looking statements. on slide 2, which I'll leave you to read in your own time. So going to slide 3, please. With me today are Eva Pinozzi-Lingsis, our CFO, and Richard Jameson, our Chief Commercial Officer. We will cover the Q1 overview and update on the very positive developments we have had with Vividal. also talk about the progress in our pipeline and partnerships and leave you with some key takeaways from this first quarter so please go to slide number four as you may have seen we have achieved some very promising results this quarter we delivered a very strong sales performance driven by patient uptake we did progress our nicely and enter into new commercial and R&D collaborations in credit to our she was very agile and resilient during and they have also worked to ensure our operational and I think delivered a standout Q1 result. Next slide, please. So on slide five, here we can review our financial performance. We made very significant and positive progress in Q1. Our revenues ended at approximately 50 million SEK. with Bovidals sales constituting almost 49 million SEK. This is a 340% improvement versus the same quarter last year. As can be seen in the figure, the quarterly sales actually increased strongly as well by 60% versus Q4 last year, driven mainly by the increasing shares in our existing market. Looking at the cost side, our OPEX increased by 18%, mainly related to the costs of our phase 3 study in Acromegaly. But overall improved by 10%. Up at the healthy cash position in line with our plans of just shy of 300 million SEK. So with that, I think we'll move over to slide number six, and I would just like to say a few words about the impact of COVID-19 on our business operations and R&D pipeline. We'll come back to the later on, as you will. So in terms of the business operations, so far they have been going according to plan. Our supply chain has been largely unaffected by this situation. And we are, of course, very closely monitoring the situation to ensure that we can supply our clinics and patients with products in a timely manner. Looking at the pipeline, we do see some impacts, of course, most clinical sites have do not recruit patients at all so we study to some degree temporarily sold at this moment address that and we have actually repocused a lot of our resources to other time critical activities including focusing on rapidly developing the auto injector and implement that also in the clinical programs And also, another secondary effect of the COVID crisis has been that our Phase 2 study for CAM2043, our long-acting trepostenyl in Raynaud's patients, has been postponed to the second half of this year. However, overall, I think we are doing very well, and as Richard will introduce you to, We're progressing very nicely with Buvidal in our market. So let's go to slide number seven. And we will then, I'll ask Richard here to take over and give you an update on the very significant progress we have been seeing with Buvidal. So Richard, please.

Okay. Thank you, Fredrik. Firstly, I'd just like to say, as we shared previously, we still continue to get great feedback from both patients and healthcare professionals about the positive impact Buvidal is having for patients, and we continue to hear many inspiring case histories, especially as the numbers in treatment grow significantly. So if we move on to slide number eight, Buvidal has accelerated in quarter one, with more than 7,500 patients now in treatment at the end of the quarter. which is a 90% increase versus the previous quarter. Towards the end of the period, we saw this accelerate further as COVID-19 became a catalyst as policymakers, payers, and healthcare professionals recognized the burden, the reduced burden that Buvedal brings to treatment settings and the benefits to social distancing. And we've seen a number of ministerial policy changes that address this. And I think this is really emphasizing the paradigm shift that Buvedal is bringing to treatment right now. We've continued to see growth in our early launch markets and now market leaders in both Finland and Norway on a brand basis. The fastest growth in the quarter came in Australia. We now have more than 3,000 patients in treatment and where towards the end of the quarter, the regulatory authority approved an extension of prescribers from only those opioid specialists now to include GPs to treat the majority of patients. In other wave one markets, that's UK, Germany, Denmark and Sweden, we also saw increasing momentum in the first quarter. as we gained access to both community and the criminal justice settings and addressed market hurdles, which I will discuss in the next slide. And finally, in collaboration with our partner Newbridge, we saw the first patients treated in the MENA region as part of an early access program. So moving on to slide nine. Well, we had significant success in the quarter addressing some of the remaining access hurdles in the wave one markets. In Scotland and Wales, the respective policymakers and governments recognise the value Buvedal brings in the current crisis, and have made additional funds available to support patients in order to access Buvedal. And you might have seen some of the wide media coverage on the newswires, which we've had over the last couple of weeks. In Germany, there was a change in the enumeration that doctors receive for prescribing, which creates a balance for the difference between the medications, and this is expected to increase the penetration of Buvedal going forward. Riverdale has also become an important element in the outreach services in the treatment community as implemented, for example, in Norway, in order to avoid travel at this time. And as already mentioned, it's opened up access in Australia to GPs. Of course, as well as increasing the uptake in the wave markets, and I want to move to slide 10 now, we're also on track for wave two launches. We are in reimbursement discussions and negotiations in several countries and are well advanced for new launches into new geographies during the next two quarters. An example of this would be Austria, where there's a legislation change in the final stages that will allow injectable treatments for dependence, and we are ready to launch as soon as that is finalized. Austria itself has about 18,000 patients currently in treatment, so this is as large an opportunity as the Scandinavian countries put together. There are significant patient populations that can benefit from access to Buvidal, of course, in the Wave 2 markets, and we're progressing with our expansion plans well. And as you can see on the next slide, in slide 11, EU and Australia are part of our global strategy for Buvidal, where there is a very significant market opportunity with, across the world, about 3.5 million patients in either treatment, a significant peak market potential. And we're working with our partners across other geographies to enable access to patients in these regions. So at this point, I'll hand back to Fredrik so he can give an update on where we are on the regulatory status. So Fredrik, back to you.

Thank you so much, Richard. And we are now on slide number 12. So I would say that, of course, we do have a very clear global strategy as a part of that. market expansion that we are targeting we have during the quarter submitted new regulatory files in our own market so so among one thing is is that we we submitted an maa to the swiss agency for therapeutic products with medic that just sent in in first quarter and then we're going to the application in new zealand We're working with our partners in the Middle East, in the MENA region, as well as in Israel, so New Bridge and there. We have the first patient started treatment in an early access program in the MENA region, which is very important for us. We're working to improve the access throughout the Middle East and, of course, also North Africa eventually. We also are working, of course, with Newbridge to expand the territory as much as possible. In the US, which is, of course, a very important market for us, we have a clear path, or Bayburn, our partner, has a clear path to approval the 1st of December. And with all the product requirements in place for that launch, Rayburn is now preparing for UNAS and the approval is in hand. So the 1st of December and shortly after that. Moving to the next slide, slide 13. We'll see that we're also continuing to work with the evidence generation In 2019, we had six peer-reviewed publications for Buvidal. We plan to publish also important results in 2020. There's a number of key results that are going to be submitted to peer-reviewed journals or are submitted this year. And we also have very high ambitions in terms of presence at key conferences this year. As you know, the COVID-19 situation has led to a number of cancellations, but some key events have nevertheless been held. So we were present at the American Society for Addiction Medicine meeting in early April and presented new results on the dose dependence and dose dependent efficacy of Buvidal and the importance of individualized We have two key presentations accepted for the College for Problems of Drug Dependence, which is maybe one of the most important meetings in this space in the year. So that event was scheduled to be held in Hollywood, Florida, but will now be going into a virtual meeting. So going to the next slide, please. Looking at the study and the further evidence generation, we have real-world studies either completed or just started. I think it's worth to say that for Duvidal, we will have soon four head-to-head studies against them. And I think that definitely separates us from any other developments in this space. So, as I reported earlier in the year, our first study, DEBU, Depo Evaluation with An Orgine Utilization Client, which was conducted in Australia, delivered and met primary and secondary endpoints of showing superior treatment satisfaction by patients. This one was accepted to CPDB and will be presented in June. The other important study that was completed in Australia is the UNLOCK study performed in the prison setting, which also met primary and secondary endpoints, and we can come back to that at the next location, will also be presented at the CPDB meeting. In addition to that, We have also started together, and this is actually driven by the Center for Interdisciplinary Addiction Research at Hamburg University. They have started a study looking at buprenorphine head-to-head against standard of care both methadone and buprenorphine. And this study will be a taste control study so that one is trying to compare patients with very similar characteristics and look into both patient satisfaction, illicit use of opioids, but also things like social participation and of course also cost-effectiveness. So this will be a very exciting study. It's a 12-month study and which will generate some very significant real world evidence, we believe. Next slide, please. So going over, as you know, CAMRS has a very broad and diversified product pipeline. And our most advanced programs, which I will just quickly comment on here, is the CAM 2038 chronic pain program. and also our 2029 long-acting osteoporosis program in acromegaly and neuroendocrine tumors. Aside from that, I will say a few words about our partnership and CAM2043, which is our long-acting tripostomil project. So please go to the next slide. So a quick update here. On the chronic pain side, we actually prepared and have now conducted a pre-submission meeting with the EMA repertoires in advance of a regulatory submission planned for the third quarter. We've also done a lot of work around the product positioning and pricing in Europe. So that is advancing nicely. In terms of 2029, Acromegaly and NET, our long-acting ostracized project, we do progress in the acro-study, but as I said earlier, most sites do not have clear reasons relating to the COVID-19 crisis. So instead, we have we focus our activities to other important things including fast forwarding the autoinjecture development and conducting a bridging case study for the further clinical development of that presentation so also worked a lot around the net program and align that with key kol and authorities in the area In terms of 2043, our CAH and Raynaud program, we got clinical trial application granted by the English authorities for a phase two study. And that study has also due to COVID been shifted from the second quarter this year to second half of 2020. Preparations ongoing for the EAH indication. Next slide, please. Our partnerships are also progressing. The rhythm collaboration, we are waiting for the phase two study, ongoing phase two study to be completed. And we're expecting to see top-line results during this year. And with raw pharma, the development of a long-acting silico plant, for treatment of complement C5-mediated disorders. There we are progressing nicely with the preparations of clinical development, and we are expecting to start clinical studies, or they are expecting, I should say, to start clinical studies in the second half of this year. In addition to that, we have actually started some new research collaborations uh with the international pharmaceutical companies during the quarter two of these and we will announce them in more detail when we are entering into clinical development or or formalizing a license agreement a long time so next slide please so with that said i think it's time to uh Look at some key takeaways from the first quarter of 2020. No doubt we have had a very, very nice quarter. Probably one of the best in our history, if not the best. Total revenues of nearly 50 million. Increase of 167% versus 2001, 2019. Also saw a very, very strong rise in the Buvedal sales. with a quarterly change of 60%. The uptake in terms of, of course, the most important thing, I think, is that we get very positive feedback from both patients and healthcare providers, and already have 7,500 patients. Of course, now even more than that in treatment with the dog. We had a very important event in that general practitioners are now allowed to prescribe Buvidal in Australia. I think maybe it's worth highlighting that they represent approximately 75% of all prescriptions. So it's not a small share, it is a very important event for us. And this is on the basis of a report that we sent to the authorities showing that we had good control in the system and that the treatment was working well. In addition to that, as I said, we're expanding with the market authorization application to Switzerland. Pipeline is also progressing, chronic pain. and also lead our activities with 2029 and our long-acting krepostenils. Next slide, please. Looking at the outlook for 2020, we have already announced that we expect revenues in the higher interval of our financial outlook. and the main drivers of that is of course the fact that we are seeing increasing digital market shares in essentially all strongly all of our markets we're seeing improved access and expanding into new markets and also on top of that being able to communicate strong and positive clinical data versus active comparators and standard of care. Looking at the cost side, approximately according to plan, it's tracking a little bit below plan right now, but we expect this to increase as the situation with COVID-19 normalizes and A3 clinic activities can be fully resumed and hopefully also accelerated. So with that, I think we have said and given the main items of this update, and the next scheduled financial update will be the 16th of July 2020, our Q2 report. So with that, I would just say thank you for listening, everybody, and are most welcome to come with any questions to us here in the team. Thank you, Eva and Richard. Thank you.

Thank you. Ladies and gentlemen, if you would like to register for a question, please press 01 on your telephone keypad now. If you would like to withdraw your question, you can do so by pressing 02 to cancel. Once again, that is 01 on your telephone keypad if you would like to register for any questions. And our first question comes from the line of Harry Sisson from Jefferies. Please go ahead to your line. There's no open.

Hi there. Thank you for taking my questions. I'll start with three on Buvidal, please. So firstly, how are you seeing the marketing and distribution costs being affected by the current COVID-19 shutdowns? And how are you adopting your commercialization and launch activities in new markets for Buvidal? Second question would be, can you give us an update on the compliance rates of Buvidal? Now you're seeing a larger patient pool. And my third question, can you just give us a reminder of the key ways to market? I know that you mentioned you were preparing for launch in Austria in the second quarter, but can you maybe remind us what the approximate timings of the other key markets are? Thank you.

okay uh thank you so much harry i will start with uh uh in in terms of uh the logistical question you were asking i think we are not seeing any significant effects in terms of the costs uh for budal as you can see uh we we have quite a strong uh our margins are are are quite um are rather improving than going any other direction so that's clear um i cannot richard later on to come back to the second quick question of how we are addressing you know the challenges in the market uh with regard to compliance rate i assume you mean retention there yes yeah yeah and and i think that we have no updates on that i mean we do see very very good retention generally as we do in the study so it it is uh We don't have any exact numbers, but I mean, our estimates are between 85 and upwards in terms of the continued retention. As you know, there's more difficult areas in Europe to actually track this, but that's the impression. And that's what we also can estimate from our in-house data, so to speak. So we do see high retention continuously. which is very positive. And then I just leave over for Richard. Would you like to take the question about access on the markets and also the Wave 2 markets, Chris?

Yeah, of course. Yes, hi, Harry. We're working quite actively. We've done a lot of digitalization of our materials, et cetera. So they're all available for patients, for physicians, sorry, when they need them. We're also doing a lot of virtual remote training programs as well for clinicians, particularly when they identify and they want to start using Boveda. So we're able to do that through various media sources, Teams or Skype or whatever they have there. So we do a lot of that. We've done some educational webinars, et cetera, as well. So we're maintaining... relevant level of contact. Obviously physicians are very busy at this time and we're not being a pain going to see them, but we're certainly there and reacting very quickly if somebody wants some training and then move forward. So that's gone quite well. In terms of the way to markets, yeah, I mean, a lot of this depends on the negotiations, the reimbursement authorities, of course, and how long they take. And that has been some delays because of COVID in a couple of them because they just aren't meeting so frequently. But certainly in the next couple of quarters, we've set movement in Austria, as I said, hopefully Spain, Benelux and Italy as well. France will probably be a bit longer.

Okay, that's really helpful. Can I just ask some follow-ups actually on CAM-2029? So you mentioned that you potentially would look at some additional indications to the acromegaly and neuroendocrine tumors that you've already disclosed. I just was curious how long... you would expect the phase 3 to 4 of those indications to potentially take? Would they be more in line with the acromegaly studies, which are a bit shorter than the neuroendocrine tumor study? And then also, just given the delay to some of the R&D activities, could we see some initial slowdown and reduction in the costs there as a result of some of those delays?

Yeah, very good questions. I mean, in terms of the additional indications, it's more of the timelines of the Accru study, definitely. So I think that you can conclude. I mean, of course, if this slowdown or, what should I say, complete stall that we are seeing in some areas or some markets continues, That will impact our cost side, you can say positively, by having lower costs, of course. So it is dependent on how long we are going to be in this situation. And of course also very difficult for us to predict. But if anything, that is the direction that things will be. If this delay continues unexpectedly, We do already see some improvements in some clinics and an increasing interest to kind of restart activities and recruitment, but it's too early to come with any kind of confidence estimates there.

Understood. Very clear.

Thank you. Thank you. Our next question comes from the line of Peter Seersted from Handelsbanken. Please go ahead, your line is open.

Hi, it's Peter from Handelsbanken. Thanks for taking my questions. I have two. One pertaining to the pain indication for camp 2038. I wonder if you could provide us some flavor. I mean, how optimistic should we be about the indication and that sort of how, I mean, we've seen a strong uptake with Buvidal, but that's probably for further reasons. But for the pain, how should we think about that uptake? That's sort of the first question, i.e., how optimistic about potential and sort of timelines to realize that. The second one, relates to your potential ambitions within the treatment of opioid dependency. If you get a milestone from Braeburn upon approval, your balance sheet starts to look relatively robust. You might get appetite to do some business development. is that are there any let's say opportunities that you see as you know particularly interesting to add on to this particular portfolio or if you were to do something would it be within other disease areas and other compounds novel stuff that could you that you could bring into your pipeline thank you thank you peter uh yes i will take those questions uh start out with the pain question i

I think what is clear is that we recently had our discussion with the rapporteurs, and I think that discussion went without any surprises to our team, of course. So there was generally a very positive view and a good alignment between the company and the authority. Of course, when it comes to the market, We are still working with our internal models and looking at... I have earlier said that we believe the opportunity overall is of the same order as opioid use disorder, but slightly smaller. At least for the type of targeted population that we are intending to address. So I think it is of the order but smaller than the opioid use disorder. And when it comes to the different markets we expect the US to be the most significant but also a market that will come in later than if we file in europe or as we plan to file in europe in the second third quarter of this year so overall we we see the potential in europe right now of around 100 to 125 million in eu5 that's our current estimates and significantly higher When it comes to the second question, the opportunity of business development, I mean, we are always looking for new possibilities there. I think that you can conclude that the opioid use disorder area or opioid dependence area, there are some very attractive, interesting opportunities But I think we will be looking also outside the core area here. Definitely. And are already doing that. I mean, we are looking to expand not only by own development, but also through our business development efforts.

Thank you very much.

Thank you. Once again, ladies and gentlemen, if there are any questions, it's 01 on your telephone keypad if you would like to register. And there will be a brief pause whilst any further questions are being registered.

OK. uh if there are no further questions i would like to thank everybody for attending this call and we look forward to updating you again soon about our continued progress and i also want to you know say that it's been a very nice pleasure this time to show you the strong progress that our teams are contributing to so Thank you and speak to you soon.