Camurus Ab

Thank you so much. Good afternoon, everyone, and welcome to our third quarter presentation. Hope you're all doing well in these very unusual COVID-19 times. Before I go into the presentation, I just want to alert you to our forward-looking statements on slide number two. And with that, moving forward to slide number three. So in today's call we will update you on our continued business progress with the commercialization of Bovidal as well as provide a brief update on key R&D programs. We will finish off with key takeaways and a Q&A session. With me in today's call is our chief commercial officer, Richard Jameson, and our chief financial officer, Eva Pinotti Lindqvist. So let's move to slide four and some highlights during the third quarter. As you have seen probably in today's report, we saw really good progress across our business areas in the third quarter, including a solid financial performance. Rovidal continued to deliver strong growth, and in the US, we have Brixadi under review by the FDA for final approval decision the 1st of December 2020. On the R&D side, we reinitiated recruitment and progressed our two phase 3 studies in Acromegaly after a temporary COVID-19 interruption in the second quarter. And these are now up in full gear. In addition, the pivotal phase 3 study program for CAMP 2029 for treatment of neuroendocrine tumors was aligned with the US FDA in a type B meeting. We raised 300 million SEC in a directed share issue in July. And finally, as you know, we are in an arbitration process with Braeburn in England. This process is confidential, however, we will communicate the outcome from this expedited process as soon as this has been received from the arbitration tribunal. So with that, please go to slide five. So turning to the finances, we continue to deliver really strong growth and financial performance. As I said in the third quarter, our net revenue amounted to 100.3 million SEK, which is 150% higher compared to Q3 2019. Our product sales were 94.3 million SEK, An increase of 383% versus the same quarter 2019 and 24% compared to the previous quarter. This despite a slowdown during the summer months in Europe and some temporary challenges relating to COVID-19. Our operating expenses were in the quarter 113.4 million SEK, so basically the same as in Q3 2019. The Q3 result consequently was minus 20 million SEK, which corresponds to approximately a 70% improvement compared to Q3 last year. So including the directed share issue in July, we ended the period with a healthy cash position of 476 million SEK. So we are in, I would say, a very good position going forward here. With that, I think it's time to hand over to Richard Jameson for an update on our progress with Buvedal.

Thank you, Frederick. So if we could move to slide six, please. Thanks. So in Q3, we saw continued progress with Buvidal. And as already mentioned by Frederick, we've grown more than 380% over the same quarter last year and 26% versus Q2 2020 at constant exchange rates. We further increased the number of patients in treatment with an estimated now 12,000 patients receiving Buvidal to support their recovery. Our lead markets of Australia, Finland and Norway continue to expand alongside acceleration in the UK, Germany and Sweden. As working with a broad group of stakeholders, we continue to address the infrastructure and funding challenges in those markets. I think this is a strong performance against the backdrop of recruitment as mentioned by Frohlich during the summer and the headwinds caused by COVID-19. which had some impact on our growth due to the delays in some external processes, such as prescription authorizations in Austria and the finalization of pricing and reimbursement applications in the Wave 2 and 3 markets. Of course, there were some limitations, too, to access the healthcare professionals. However, the demand for information remains high, and our team remains very active in engaging healthcare professionals through virtual face-to-face meetings, training, and medical education. And we've gained some momentum again after that summer slowdown. Buberdal is now available in 11 countries and we're well advanced to launching new territories by the end of this year. So we can move to slide seven for a quick update on the EU and Australian launch. We continue as market leaders in Finland and Norway, where we have significant market shares. In Australia, we're seeing strong development, basically in the GP segment, as they're now approved to prescribe. Sweden is also showing good progress with the reimbursement by TLV in May. And England, we have some significant developments that will increase access to patients. And in Germany, we're seeing the positive impact of the modified remuneration for physicians. Of course, we're sharing these positive experiences with the next wave of launch countries. And if we go to slide eight, I can talk about those. So we're now aiming to launch in the Wave 2 and 3 markets that have a population of about 350,000 patients in treatment for opioid dependence. We've submitted multiple pricing and reimbursement applications as planned in Spain, in Portugal, Belgium, Netherlands, and France. And whilst there have been some delays in the external pricing and market access processes due to COVID, we are anticipating two or three further launches in Q4 this year and others in early 2021. As part of this expansion in EU countries, we're also progressing our market expansion elsewhere. So if we can move to slide nine, please. As Frederic's already mentioned, our US partner is preparing for launch in the US with the Purdue for date, 1st of December, which triggers that $35 million milestone for cameras. We're also working on regulatory filings in other markets and have achieved pre-approval in Switzerland and are in the final stages of the process in New Zealand. And with our partners in the MENA region, we've initiated some early access schemes to allow patients to access Buvidal whilst we submit regulatory files. And in addition to this, we've also completed the work and submitted line extensions and label enhancements for Buvidal as part of our lifecycle management plans. As we shared previously, I think the success of Buvidal is built on the foundation of a strong evidence base. So if we can move to slide 10. The compelling evidence base for the efficacy and safety of Bruvidal continues to be shared at scientific congresses, and although many of these meetings have been held virtually, we still have seen strong presence, giving an indication of the interest in this new treatment option. As a recent example here is the improving outcomes in the treatment of ochre dependence meeting that was held virtually in September this year. And here we saw more than 750 healthcare professionals register who accessed four oral presentations on long-acting injectable buprenorphine and seven scientific posters. The presentations included updates on the clinical studies, including results from a recently completed debut study that showed statistically significant improvements in patient reported satisfaction with efficacy and the convenience of buprenorphine compared with standard of care. The posters, the seven I mentioned, focused much more on the real-world evidence and the experience with Buvidal in the clinical settings and continue to demonstrate the significant and positive impact Buvidal is having on the lives of patients suffering from opioid dependence. I think it's hearing about these real-world experiences that makes Buvidal such a rewarding product to work with, and we continue to accelerate our plans to improve access for patients to Buvidal across the world. So with that update, I'll just hand back to Fredrik now for more details on the pipeline and our news flow. Fredrik.

Yes, thank you, Richard. And as you know, we have quite a deep and broad pipeline that we are working with, and we have made excellent progress also during this quarter, moving these programs further. One very important thing is that we are working with the regulatory side of CAMP 2038, both in relation to... So we are now on slide 11, sorry. New regulatory filings for CAMP 2038 in several different countries. We have been advancing our PIVOTO phase 3 program for CAM 2029, and I'll come back to that soon. We've completed a development of an auto-injector, which will make administration of long-acting depots even easier than our earlier device. And we have got new approvals for clinical trials. We have seen positive development in our partnership programs in several of these, including with CAM 4072 with Rhythm after the announcement of positive phase two data in June. So next slide, please. So I'll start here, just an update on one of our key programs. It's CAM2029, our long-acting octreotide in development for treatment of acromegaly and neuroendocrine tumors. So slide 13 then. And for those who have not been exposed to this program or need a reminder, CAM-2029 is a new long-acting octreotide product designed for enhanced efficacy and improved convenience for patients. This product combines rapid onset and long-acting release, and we have demonstrated a 500% increase in bioavailability and improved exposure compared to current products. In this case, it's Sandostatin LAR, which is marketed by Novartis. Sandostatin has a market of approximately 1.6 billion US dollars, so this is by no means insignificant. With the work that we are doing with CAMP2029, we are aiming to significantly improve convenience for patients, which will also have an important dimension for payers as we go for easy self-administration by patients and can avoid the difficulty of physician-administered intramuscular injections. With that said, we'll go to slide number 14 and our ongoing phase 3 program in Acromegaly. This program consists of two clinical studies, one controlled study where CAM-2029 is studied against one monthly placebo injections in stable acromegaly patients and then this is also complemented by a long-term safety and extension study called the 647 study where we are recruiting both neutral treatment patients which can be either stable or be not well controlled and following them over 52 weeks. Here patient Recruitment was reinitiated in the early third quarter and we have seen a good uptake since then and both studies are progressing well at the current. Our projections is that the pivotal efficacy study will be completed during 2021. while the open-label long-term safety study will be completed around mid-2022. So that's a quick update on the acromegaly studies. In addition to that, as I said, we are also about to start the phase 3 program for treatment of neuroendocrine tumors. And here, we had a meeting during the quarter with the US FDA. It was a very positive meeting to align on the pivotal study program for CAM-2029 in this indication. And we have then agreed on a study, as disclosed here, will be a randomized multicenter open-label parallel group active control trial. And the main objective with this is to assess superiority of treatment with CAM 2029 compared to current standard of care. This study is planned to start early next year with an expected completion in 2024. So moving to the next slide, you can see that our program for 2029 quite large we have ongoing phase three studies in acromegaly which are progressing and about to start the neuroendocrine tumor phase three program and in addition to that we are also initiating a third program in patients with polycystic liver disease it's an indication where there's currently no approved treatment and a large medical need. This week, actually, we also started a clinical trial, a phase one trial, bridging pharmacokinetic trial of the autoinjector, which we spoke about earlier here in the call. So there's quite an exciting time for the program and a lot of activities going on. We can go to the next slide, please. slide 17. We have, for these different indications, conducted a series of market research studies with the third party about the potential of CAMP 2029 in the different indications, including interviews with stakeholders, physicians, as well as payers in the US and Europe. and the outcome of those investigations are shown on this slide and as you can see by the arrows that the target profiles that we are addressing in the different indications we see a very significant potential of camp 2029 across these indications ranging from around 150 million up to, for neuroendocrine tumors, about 700 million in peak sale potential for the product. So with that, please go to the next slide, slide 18. I also just mentioned that we saw good progress in our partnership and partnerships. And as an example of this, we just show some of the data, that positive data that came out of the rhythm phase two study, which was announced late June 2020, which showed that CAM4072, which is long-acting set melanotype for treatment of genetically related obesity disease, was well tolerated and that it generated a weight loss in this population that was comparable to that of the daily formulation since then rhythm has presented data on the pharmacokinetics properties properties of the product comparing the weekly formulations to their current daily formulation, which is the beta in the green curve. So what you can see here is that CAM4072 exhibits dose proportional pharmacokinetics, and these are basically only Z-trough values to the end of the treatment interval. which can be well tuned into the interval or to the levels of the daily injections. So it will be exciting to follow this program as we go forward. To the next slide. So as a summary of this presentation, we have had quite good progress in all of our activities in the company right now. And As you can see from our anticipated news flow during 2020 and 2021, we have a number of very important events in front of us, including, as I mentioned before, the final market approval of Brixadi and the start of a new clinical program with CAMP2043. It's our long-acting trepostenil in Raynaud's phenomenon. as well as the initiation of the long phase III study in neuroendocrine tumors. Next slide, please. So I think we can say that we continue to deliver on our strategy. We have established a very strong position in opioid dependence in Europe and Australia over the last year. And we are only a month away on 1st of December for an anticipated approval decision for Brigsari in the US, which is the largest market, of course, for opioid dependence treatment in the world. We have seen a good advance and growth of our pipeline of innovative medicines for treatment of chronic pain, endocrine disease and other disorders. And on a corporate level, we are expanding our commercial capabilities and preparing for new developments and also for developing and establishing sustained profitability through own sales partnerships and business development. Finally, some brief comments about the full year 2020 financial outlook. This is slide number 21, where we reiterate the guidance for net revenues and sales for the full year, which were raised in June, earlier in June. However, we have reduced the full year operational costs, full year OPEX, from 570 to 610 million in interval to 505 to 525 million, which of course will result in a corresponding improvement of the full year operational result. This adjustment is mainly due to updated clinical development timelines, including manufacturing and clinical studies. As an example, we are moving over manufacturing of validation batches from Q4 to Q1 next year. And we have also seen significant reduction in costs for Congress's travel and marketing activities. So with that, I thank you for listening, and we'll move over into a question and answering session.

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. And our first question comes from the line of Harry Sefton of Jefferies. Please go ahead.

Yeah, hi there. Hello, Harry. So just to start with, can you maybe comment on some of the in-market dynamics that you're seeing, especially in terms of converting methadone patients over onto buvidal and also the expansion of the current buprenorphine patients in the market?

Yes, I can start out by just saying that a very interesting question and I think It's a little bit special with Buvirag because we do see that an interest among both patients and physicians to transfer from methadone over to buprenorphine, which you don't see to the same extent, I believe, for sublingual buprenorphine. So that dynamic is certainly there, but I'll hand over to Richard to kind of give a more detailed picture around that question.

Yes, thanks. Hi, Harry. Yeah, we are seeing this increasing, so as Frederick said, we're seeing patient demand. They do like the idea of a less burdensome treatment option for them, and so they are prepared to move. Obviously, there is some movement down to 30 milligrams, which is our dose to transfer on, but we are seeing that increasing over across the markets. Your other question was about expansion in the buprenorphine segment, I think, and that's another interesting question. We're certainly seeing We know there's a group of people outside of treatment that don't come into treatment because the current burden they're faced with the daily dosing. And we're now seeing increasingly those numbers come into treatment, more patients like that coming into treatment now because there is a new treatment option. And again, we've seen that in two or three countries where more patients are coming in. That will inevitably expand the buprenorphine segment in time.

That's very helpful. I'll just move on to Brixardi now. Can you confirm whether you expect the Brixardi launch to happen in December? I think that you clarified in your report that the licensing agreement is still in place even through the arbitration proceedings, but I'd just like to get a clarification from you. And then also, just in the same vein, do you expect a similar level of legal expenses in relation to the arbitration in the fourth quarter of this year?

i think that uh you know the the intention of course of of of our partner rayburn is to launch the product as quickly as possible so so that that is answer to the first question and i think you know their ambition is to be on the market as soon as possible you know providing the circumstances are the right ones

um and it's also of course dependent on on other ongoing processes but uh certainly that's that's my understanding uh on the second question harry i forgot sorry it's just in terms of uh in terms of your administration expenses they were up quite significantly in the third quarter i understand that as a result of the arbitration uh legal expenses uh just wanted to yeah if you expect a similar level of legal expenses in the fourth quarter?

Hi, Harry. I can comment on this. Yes, I agree. We had some significant costs in Q3. We foresee that they will not be to the same extent in Q4, but that is without regard to the outcome of the legal process. So camera's legal costs are included in that

Okay, brilliant. That's very helpful. And then just in terms of SG&A, given that you've had SG&A is relatively flat during this year, I'm just curious what you expect the level going into next year. Obviously, it will be largely dependent on what happens with COVID-19, but would you look to significantly increase your SG&A spend going into next year?

With the current plan, we're seeing a relatively modest increase, but it's definitely up in the double-digit territory, so I would expect somewhere around the area of 20% increase. Is that right, Eva?

I confirm that, considering that we can continue to expand the markets as planned and not

uh being hit by further or any coded related issues unexpected unexpected that's very helpful thank you that's all from me just to remind everyone if you would like to ask a question please press zero one on your telephone keypads we'll now have a brief pause while any further questions are being registered And there are no further questions at this time. Please go ahead, speakers.

Okay, thank you very much for listening in on our call today. We just want to say that we look forward to having you all coming again for our Q4 call next year. And we're looking forward to a very exciting finish of 2020. So thank you very much. And with that, I think we can