Camurus Ab

Thank you. Good afternoon, everyone, and welcome to our Q2 and a half year results presentation. It's been another good quarter for Camurus. Before starting, I want to alert you to our forward-looking statements, which you can read on your own leisure. Slide three, please. To the agenda. In today's presentation, we will provide an update on our financial results, market performance and pipeline progress. We will finish off with key takeaways and some questions. And with me today I have Chief Financial Officer Eva Pinotti Lindqvist and Chief Commercial Officer Richard Jameson. Let's start on slide four. So, as I said, we had a good quarter. We continued to make excellent progress across business areas towards fulfilling and exceeding our goals for the year. Key highlights in the quarter included a strong financial development and growth of sales of Buvidal, market expansion to second wave countries in the EU, A request for final market approval of Brixadi was sent to and accepted by the US FDA with a PDUFA date set to 1st December 2020. An arbitration process was initiated in England following our issuance of a material breach notice. And we continued to advance key projects in our pipeline um of innovative treatments and announced positive phase two results in the collaboration with rhythm after the period we successfully completed a directed chair issue raising approximately 300 million second gross proceeds to increase our financial flexibility and to be able to invest in market expansion for buvidal development of a new indication for our long-acting octreotype program and for general corporate and business development activities. So going over to slide five. In the second quarter, on the financial side, we delivered strong growth and performance. Our net revenues amounted to 18.8 million SEK. which was up 580% compared to the same quarter in 2019. Our product sales were 75.8 million SEK, which was an increase of approximately 570% against last year and 56% compared to the last quarter. Our operating expenditures were 102.1 million SEK, actually down by 15 percent compared to 2019 and this was mainly due to the fact that we took a lot of startup costs for the phase 3 acromegaly study in the second quarter of 2019 so the result for the period it ended at minus 20 million sec which corresponds to a 77 percent improvement compared to 2019 At the end of the quarter, we had a cash position of 222 million SEK. And to this, we can now add the proceeds from the directed share issue, which has further strengthened our cash position. So moving on then into highlights of this presentation, it's updating on Buvidal. and this is then slide number six so as you're aware i think on the negative side here of course is that opioid dependence continues to be a huge and growing global problem which has become a public health crisis in the us as well as in canada and a number of other countries Unfortunately, an already dire situation has only gotten worse by the COVID-19 pandemic. Drug overdoses are soaring around the world with a significant spike seen in the data, for instance, provided in the recent Washington Post article. This is on top of an already unacceptable overdose death rate in the US of almost 130 people per day. Actually, New York Times published yesterday another update showing that drug overdoses are beginning to increase again in 2019, and as you see, continuing in 2020. So there is an urgent need for new treatments that can provide improved outcomes and improved access to treatment as well, reduce burdens, on patients and the health care system. And we see that our product Luvidol can deliver that. And at this point, I would like to leave over the world to Richard Jameson for a short update on the commercials. Slide seven. Richard, please.

Yeah, great. Thanks, Frederick. Firstly, I'd like to say what a pleasure it is to work each day with a product that really does make such a difference to the lives of patients from the feedback we receive and also contributes significantly to society as a whole. As you already know, Bruvadil is the first prolonged-release injection-approved treatment of opioid dependence in the EU and Australia. It's the only treatment available in multiple weekly and monthly dosages, allowing flexibility to individualize treatment according to a patient's need, which is so important in this area. It's also the only prolonged release treatment that has demonstrated superiority in head-to-head clinical studies against standard treatments with daily buprenorphine, and a bit more about that later. So if we could move to slide eight, please. We're very pleased with the continued strong growth of Boeverdale and Q2, and the continued amazing feedback we received from both patients and healthcare professionals from our markets. For the fourth consecutive quarter, Boeverdale sales increased by over 50%, and we now have in the region about 9,500 patients in treatment in our markets. The COVID-19 pandemic has had positive and negative effects on sales, as you'd expect. It's been a catalyst for the transition from daily medication to weekly and monthly treatment in clinics with boovidal experience and has shown clear and obvious benefits for the criminal justice setting. And our teams have done a really excellent job supporting and training clinics via digital platforms when access to clinics has been stalled due to the pandemic. On the counter, that limited access has, to healthcare professionals, had delayed patient initiations in some clinics and some markets. But during that time in Q2, we also achieved several significant milestones in addressing the market access challenges that we raised in the Q1 report. In Sweden, we received approval for reimbursement and now seeing a positive impact of this across the country. In Australia, the prescriber base was widened by TGA to include GPs, and we've already established accounts for GPs with high patient numbers. And in Germany, the remuneration change has resulted in more clinics initiating Buverdal in the community setting. And during this time, we also continued to work to establish Buverdal in the next wave of launch markets. We saw a legislative change in Austria, which allowed for the launch of Buverdal, and the first patients have now been initiated in treatment in Austria. We're also preparing for launch in second wave countries with Belgium, Netherlands, Spain, and Iceland expected to launch in Q3, as well as supporting the MENA region where patients have already started to access Buvedal. So we can move now to slide nine. We're also making good progress on our regulatory activities. Firstly, to open new countries, we have ongoing reviews of the MAAs in New Zealand and Switzerland. and are supporting Newbridge with their regulatory submissions for the MENA region. And we're also delivering on our lifecycle management plans with line extension applications and labour enhancement submitted to the EMA. As you heard from Frederick earlier, our US partner is now a clear path to market approval. The FDA granted the citizens position in 2019 and the finding for the final FDA approval of the NDA for Bixardi was accepted by the FDA and the PDUFA date now is the 1st of December 2020. So we really have now built a strong foundation for continued growth of Buvidal, supported by the unique clinical data and the great patient and physician experience that we're seeing. And I'll hand back to Fredrik now to update on the progress on the clinical side, moving on to slide 10. So, Fredrik.

Thank you, Richard. During the period, we have continued to build on the already compelling scientific evidence base for Buvidal. We and our scientific collaborators, and I must give them a large thank you for their great work, have been active in preparing papers and publishing in peer-reviewed journals. Despite the COVID-19 situation, we have been able to present new important data for Buvidal at key scientific conferences. including ASAM, American Society of Addiction Medicine, in April, and also recently at one of the key meetings in the year, the CPDD Annual Meeting, where results from two prospective clinical studies, the DEBU and UNLOCKED studies, were presented. In both cases, demonstrating significant benefits of Buvidal in real-world-like clinical settings. So moving over to slide 11, I think this was one really strong example of our development activities. The Buvidal study was a 24-week randomized controlled study performed in the community setting in Australia. where the focus was on patient reported outcomes, PROs, including patients' global satisfaction with treatment as a primary endpoint and other satisfaction measurements, treatment burden, quality of life as important secondary endpoints. Despite the quite limited size of the study featuring a total of 120 patients with 60 in each group, we were able to demonstrate superiority for the primary endpoint with statistically significant improvements in patient reported global satisfaction and also improvements in patients views on the effectiveness and convenience of the Buvidal treatment versus standard of care. In Australia, the majority of patients are on sublingual film. Suboxone sublingual film is the standard treatment in most instances. In addition, patients treated with Buvidal reported significantly reduced treatment burden. higher quality of life and improved physical health compared to those receiving daily sublingual treatment so overall the debut study was highly successful thanks to the excellent work and efforts of our investigators clinical staff and and not to least the patients that were participating in this important study so going over to slide 12 We also completed a second study. The results were presented at the CPDD. It was an unlocked study. It was a non-randomized, open-label, multi-site study in patients who received Buviral versus control group on methadone. The study was performed in eight prisons in New South Wales. The sponsor of this study was actually the government of New South Wales with cameras contributing with drug products. This unique study showed that Buvedal had a good safety profile with no observed events of drug tampering or diversion. It resulted in significant reduction in drug withdrawal and a high retention in treatment in this setting. Importantly, the study also showed a significant reduction in treatment costs with Duvidol. It was a 60% reduction compared to methadone. and the 90% reduction of treatment costs compared to sublingual buprenorphine reported from the study. Three months after the study was completed there was more than 500 patients in treatment that had switched to buvidol in New South Wales prisons and this process continues. To further build on our already strong scientific evidence base with Buvidal, we also have, during the second quarter, started to recruit patients into the investigate-led study in Germany called ARIDE, comparing Buvidal in Germany, weekly and monthly, against treatment as usual. We're looking forward to the results from this study. It's a one-year study. and together with recruitment we believe it will take approximately 24 months to complete all right going forward here um i will wrap up the updates about do it all by mentioning also the arbitration process that was recently initiated in england by our u.s partner bravern after we had served them a material breach notice which questioned their performance in relation to preparing for regulatory approval and commercialization of camp 2038 for opioid dependence in canada as well as the approval and launch of the exciting weekly for oud in the us and and also preparing for regulatory approval and commercialization of CAM 2038 for chronic pain. Braeburn has, as you can see in our press release, disputed the validity of our material breach notice and this will be decided upon through a 90-day arbitration process. with the potential outcomes that if the tribunal finds that Braeburn is in material breach, cameras will be entitled to subject to a 60-day cure period to terminate the agreement and regain all rights granted to them. Should the tribunal find that Braeburn is not in breach, than material breach studies, then the license agreement will remain in full force and effect. But for further information and details on this, we refer to our press release from the 15th of June 2020. And going forward, we will inform of any material developments in relation to the arbitration process as per market rules, of course. So with that, I think I'll move into the second part of the presentation. It's giving you an update on the pipeline progress. During the quarter, we have achieved very significant progress in both in-house and partner programs, including CAM 2038 for chronic pain, CAM 2029 for acromegaly and neuroendocrine tumors, and not the least, CAM 4072 for genetic obesity disorders, as well as other development programs that we have ongoing in-house. We have got several patent applications granted in the period, including a new patent for 2029 in the US, which has the validity until late 2037, which is, of course, very positive. Going to slide 15, I'll just give you some snapshots of where we are with our different activities, key activities. For CAM 2038 in chronic pain, we held the pre-submission meeting with the IMMA rapporteurs. And we are now in the process of finalizing work on product positioning and pricing. and are intending to submit an MAA to the EMA later in this year than during the second half, of course. For the Acromegaly program, or 2029, I should say, in a broader sense, we initiated recruitment in the phase three, reinitiated recruitment in the ACRO phase three studies. and after a COVID-19 stall. And we also worked a lot with the autoinjector development, which is now ready for clinical trials. And we are about to start bridging PK study for the autoinjector in second half of the year. We're also working with the neuroendocrine tumor program with phase three studies planned to start early 2021. And also, we have decided to start a new program in polycystic liver disease, a new indication, which will be starting late Q4 2020. We have also had some progress with 2043, where we are planning to start a phase two study later this year in Reynolds phenomenon. But I will start going over to slide 16 here and just give you an update about this polycystic liver disease indication that we are progressing into. It's a rare chronic disorder with significant negative impact on patients' well-being and quality of life. Today there is no approved treatment for PLD, but results from clinical studies of octreotidine patients with PLD suggest that CAM-2029 can be an effective treatment. We believe that we have a good exposure range for this indication. Our market research also suggests that there is a significant market opportunity for 2029 in PLD. with estimated peak sales potential in the region of 400 million US dollars. After financing and board approval, we are now initiating formal development activities as a part of the overall 2029 clinical development program shown on slide 17. So here, slide 17, as you can see, We have two phase three studies ongoing in acromegaly and are planning to start a bridging PK study for the autoinjector second half, a phase two study for PLD around the new year, and also a predozal trial of 2029 for NET early 21. So it's quite a lot of activities going on. The actual program has been affected by the COVID-19 outbreak, but we think that the effect will be limited to a delay of between three to six months in worst case. So we expect completion of the phase three efficacy study in the second half of 2021 and the long-term safety study in the first half of 2022 with the ambition to submit a first MAA flash MDA in the second half of 2022. So moving over to slide 18 and to some updates on our partnerships. In the quarter we announced positive data from the phase two study of once weekly set melanotide, an MC4 agonist. in participants with severe obesity. The study was performed by our partner Rhythm, and it showed that the once weekly fluid crystal formulation of set melanotype resulted in comparable weight loss and daily injections with the potential of both improved patient convenience and compliance, of course. Both formulations were well tolerated systemically and locally. And the next step for RYTHM in this process is to have discussions with the FDA about the registration path for the once weekly formulation. And I should also say that an NDA is currently progressing in review for the once daily formulation in the US. so with that i also should mention that we have had progress of course in the collaboration with raw pharmaceuticals with the plans to start clinical development later on this year and going to the next slide slide 19 and i think you can see that we definitely have had lots of positive results during the first half of the year and also some Good news flow. And we are expecting this to continue during the third and fourth quarter. Of course, one important highlight here being the expected US approval for Bixadi in December. So going over to slide 20. I think in conclusion to this presentation, we have really had a successful second quarter where we have delivered strong growth with net revenues of over 50% for the fourth quarter in a row. This was mainly due to the continued high demand for Bovidal, improved market access And also expansion of course into new markets a process that we will continue Over the months and years to come Finally, we we also saw good progress in our pipeline collaborations with pharma partners With the potential to become, you know significant value drivers in the coming years Before I finished i would just like to go to slide 21 and for an update about our full year 2020 financial outlook and say that we are repeating the updated guidance from the 23rd of june this year the guidance for net revenues was then raised to the interval from 290 to 330 million sec to 340 to 380 million SEK for net revenues and we also increased of course the guidance for product sales from 240 to 280 to 310 to 340 million SEK. Guidance for full year OPEX remains the same so in summary we do expect you know significantly better 2020 results than anticipated and with this i think we are standing very strong here at this moment and i think that's a good time to conclude the presentation and open up for questions so please thank you if you would like to ask a question please press zero one on your telephone keypad if you wish to withdraw a question you may do so by pressing zero two to cancel

That is 01 if you would like to ask a question. There will be a brief pause while questions are being registered. And our first question is from Peter. She said from Handelsbanken. Please go ahead. Your line is open.

Yes, Peter from Handelsbanken. Thanks for taking my questions. I actually only have one relating to your ongoing, say, dispute or whatever legal interaction with Greyburn. In that respect, first of all, you say that your legal costs are sort of embedded in your four year guidance so either you plan this from the beginning or the spread of that guidance is so large that and the costs are so low that you know it doesn't really impact you know costs in any way significantly but secondly assume that you that you assume rights to to be in the US I guess you would have to explain to investors you know what you're seeing going forward how long time it will take for you to establish the commercial sales falls etc etc in the us so josh your thoughts on those two items thank you yeah i think that the first first two comment is of course that we have not planned for this from the beginning but i think the situation is that that we have

saved quite some cost and due to COVID-19 and this is partly because the marketing budgets etc have gone down significantly and we have also seen other effects on our cost base so and that includes of course the r d that has not been uh according to our as you say the kobe 19 stall has impacted the uh so that that just is explained by by those cost savings you should say i should say that of course The costs that we have saved on the phase three stall, they are of course just shifted to later on and they will become more into 2021. So that was the answer to your first question. Could you please repeat the second one, Peter?

Yes, sure. In the case that you assume rights to Bixadi in the US, I mean, you have to answer questions regarding, you know, what to do. Either, you know, re-outlicense it or go yourself. That will require investment in commercial infrastructure, et cetera, et cetera. A delay to launch, but potentially also a bigger share of the cake down the road. So, I mean, what kind of thoughts have you made at this point in time Should you resume RISE super excited in the US?

Well, I should say that I think it's premature for us to discuss that. I mean, we're of course planning for all scenarios. But I do think it is premature at this stage to discuss that option. But we will certainly update the market as we go along here with any alternatives. But we will look at the situation and we will plan for all eventual scenarios. That's what I can say today.

Okay. And you're still looking for some kind of a solution around October?

Well, I mean, what we have said that, you know, it's stipulated as a 90-day period. And definitely, we will update the market on any material developments in this process. But at this stage, we will stick to the information that we have provided in this press release. And should there be any significant deviations from that information, of course, we will be updating the market of that.

Okay. Thank you.

And just as a reminder, if you do wish to ask a question, please press 01 on your telephone keypad now. And as on no further questions, I will hand the word back to the speakers for any final comments.

Oh, okay. Thank you. Thank you all for joining this call. And we, of course, from Cameroon's side, wish you all a very nice summer. a safe summer as well and our next quarterly call is the 5th of november at 2 p.m cet so looking forward to presenting our progress to you again then meanwhile enjoy the summer thank you