Earnings Call: Q1 2021

May 6, 2021

Thank you, and good afternoon, everyone. Welcome to Kemira's Q1 Presentation in 2021. It's been a good quarter. Go to the next slide, please. And of course, as always, we have forward looking statements in this presentation. And so please read them at your own leisure. I have some technical difficulties here. So sorry about that. They are now solved. The agenda for the day includes a summary of Kemers' 1st quarter financial and operational result That will be followed by an update about the commercialization of Bouvidal and progress of key pipeline programs. And as previously, we will finish off with some key takeaways followed by a Q and A session. With me on the call today, I have our Chief Financial Officer, Eeva Pinati Linked and Chief Commercial Officer, Richard Jameson. So let's move to Slide number 4, an overview of the Q1 results. In the Q1. We continued to make significant progress on key priorities. We had a strong commercial development some progress with Bovedal. We continue to expand our commercial platform in Europe and Australia with investments in Spain, France, Benelux and Switzerland. We successfully progressed our life cycle management activities for Boveda and received new regulatory approvals as well as patents. And we continue to build the evidence base for the treatment in different treatment settings. We also made good R and D progress with the ongoing Phase III studies in acromegaly, Phase FDA Safe to Proceed letter was issued for our Phase III study in harrandocrine tumors. I'll come back to that later. And also, we had a scientific advice with the FDA on our polycystic liver disease program. In addition to that, we also had good progress in the early phase development as well as our partnerships and R and D collaborations. Our financial performance continued to be positive with a continued strong revenue growth and improved financial results, ending up in a robust cash position. The full year financial outlook could therefore be less unchanged. And with that, I'll move to the next slide showing the development. And as you can see in the figure on the left side, Our total Q1 revenues has increased strongly since the first launch of Bilbrel in 2019. Compared to the Q1 in 2020, our total revenues increased by 155 percent SEK 226,000,000. While our operating expenses increased by 16% NOK 236,000,000. This resulted in an operating result overall of NOK 26,000,000 minus SEK 26,000,000 compared to minus SEK 77,000,000 in 2020. I want to raise a finger of caution on this note just for you to know that, of course, our R and D expenses are likely to increase over the rest of the year because of the start of Phase III programs as well as other clinical activities. Nevertheless, we have finished the Q1 with a healthy cash position of SEK 428,000,000, and we're maintaining our full year financial outlook that we presented in the Q4 report on 11th February 2021. With this short introduction, I will now hand over to Richard for an update on Dovidal. And that is then on Slide 6. Thank you. And please take over, Richard. Thanks, Frederic. So yes, just to confirm Slide 6. And this is just a quick reminder about bupadel, our flexible weekly and monthly subcutaneous bruprenorphine for the treatment of opioid dependence. It's an innovative product that provides significant benefits to patients' anxiety. Our strong evidence base has demonstrated both treatment outcomes, Improved treatment outcomes and patient satisfaction. We've shown a reduced burden of treatment and improved quality of life for patients and addressed any of the other limitations of the current dengue treatments and the costs associated with those. We hear many patient stories like the one on the right from Justin, a patient in Australia, We talked in our annual report about of how Omidyol has helped him support him in a way out of the cycle of addiction that you didn't have with the daily treatments. So if we move on to Slide 7 and talk a bit about opioid dependence during the pandemic. The pandemic has undoubtedly had a significant impact and exacerbated the global health crisis. So this can be demonstrated on the graph on the left slide with a slide showing a serious issue of escalating overdose deaths, in this case from the U. S. And this really emphasized The need for better access to care and new treatment alternatives. I think it's widely accepted now that investment in treatment brings substantial value to society and to patients, of course. And this growing crisis is being recognized through increasing commitment from governments as they tackle these challenges. And as examples, there are 2 cases here that demonstrate the significant investments being made. 1, the large $1,500,000,000 commitment from the Biden government that they're making in the specifically for U. S. In the U. S. For substance abuse prevention and treatment as part of the American Rescue Plan Act. And as another example, the Scottish government pledging GBP 250,000,000 to address the rising drug related deaths. And as part of this policy, they directly recognize the role long acting group Norden can play in this response. So this brings us on to the performance of Bouvard Alto. Please move on to Slide 8 and our launches across EU and Australia. Despite the very challenging period, in Q1, we've successfully continued to build access and penetration into our launch markets, resulting in strong growth with sales up 156% versus previous year and 20% on the previous quarter. We have exceptional market penetration in Australia and the Nordics after just 2 years and are making good progress in U. K, Germany alongside the smaller markets. This is a strong performance in light of the pandemic, which remains a barrier for uptake and has limited our face to face access with Clinics. So our teams continue to engage with healthcare professionals and other stakeholders through virtual platforms where necessary. With an estimated 18,000 patients in treatment now at the end of the quarter, we continue to receive clear confirmation of the value and benefits Bouvardal brings. The importance of the flexibility to match patients' needs is clear alongside the opportunity to individualize treatment for patients across treatment settings from underserved populations such as the homeless through to those more stable in treatment. We continue to expand access to Bouvudal and it's now available in 15 countries across Europe, Australia and the MENA region. And we're progressing further rate launches in Wave 3 markets during 2021. And if we can move to Slide 9, please, I can give an update on those. So in the Netherlands and Switzerland, we're in the very final stages of reimbursement process and plan to launch as soon as possible. In France, we had a very positive outcome from the assessment by the HAS. So we're now accelerating the 1st phase of the launch in Q3. In Portugal, await the outcome on our reimbursement dossier, which has been delayed by the authority due to the pandemic, but this is anticipated soon. In Croatia and Slovenia, we've made reimbursement submissions, which are undergoing the country processes and we're on track for launch in Q3. And we continue to work with our partners in the MENA region with early access programs and regulatory submissions across that area. In New Zealand, we received market authorization as part of our geographical expansion and life cycle management strategy. On that point, I'll hand back to Frederic for an update on that as we move to Slide 10. So Frederic, back to you. Thank you, Richard. And over to a brief pipeline update. We are now on Slide number 10 here. So where we will start actually with the regulatory update on bruvidal and Brixadii in the U. S. And the rest of the world and also discuss our late stage clinical programs with a focus on CAM2029. So over to Slide 11. As I said, we are had a very successful quarter for our regulatory team where we received regulatory approval for buvidal in New Zealand. We also received a positive opinion from the CHMP for approval of a new 160 milligram monthly dose of Bivotal, adding further to the flexibility for treatment providers and Patients with regards to individualizing doses according to patients' needs. After the quarter, we also got an approval for the 160 milligram dose and also aligned the label in Australia with the EU lead label allowing direct initiation with Bivirael weekly without the need for stabilization on daily sublingual therapy first. In addition, a number of regulatory submissions have been processed ore prepared in different regions during the quarter, and we are expecting to see the first regulatory approvals coming through after the summer in MENA. In the U. S, following the December 2020 complete response letter, our partner, Braeburn, has been working closely with their manufacturer and also in close contact with the FDA to address and tackle the CRL issues. And we continue to expect a PDUFA date and approval sometime in the second quarter this year. We also was granted a new U. S. Patent for Dovidral, extending the patent lifetime for the weekly formulation to July 2,032. Finally, our team is preparing for a market authorization application submission to the eMAb for the chronic pain indication with an expected submission towards the end of the year. So with that, over to Slide number 12 and an update about the clinical program for our OX3-thirty subcutaneous depot. Before going into the as I mentioned, CAM20 29 is designed with the aim to provide enhanced efficacy and improved treatment convenience for patients with rare and chronic disorders, including acromegaly and neuroendocrine tumors. Over to Slide number 13. We have an extensive clinical program going with CHAM2029, including currently 2 ongoing studies for acromegaly. And as you will see later on, starting up in net and polycystic liver disease. Recruitment in our acromegaly study has been impacted by COVID-nineteen, but it's accelerating as more and more clinical sites are opening up. And overall, we expect delays to be limited. We will now move to Slide 14 for more details on these development programs. So as I mentioned, we have 2 ongoing Phase III studies in Acromegaly, 6 month placebo controlled, randomized controlled trial and a 12 month long term safety study. These remain on track for NDA and MAA submissions in late 2022, and we have initiated early prelaunch activities as well in this area. During the quarter, we received a safe to proceed letter from the FDA allowing us to start a 3rd Phase III study of KAM-twenty 29 to assess the superiority of KAM-twenty 29 in treatment of neuroendocrine tumors. And following the FDA acceptance, this study is now being started. We also completed a scientific advice with the FDA regarding the clinical development in polycystic liver disease, DLD. And based on the constructive and positive feedback from the agency, we are now developing the last part of the patient reported outcome measures, which will be an important endpoint in this study and finalizing the protocol development of SELIS2-three clinical study, which we plan to launch in the second half of this year. Finally, there's a lot of ongoing activities in 2029. We are conducting a pharmacokinetic study where we are comparing the data using our prefilled syringe configuration that we have used in previous studies with the new auto injector device or as it will be referred to a prefilled pen format. This study has progressed well, and we are expecting all patients to be completing treatment in the single dose part of the study during this quarter. The pre filled pen device will be fully validated for clinical and commercial use in July this year and we'll be introduced also into 2 of the Phase III studies. We believe that this will be a further important differentiator for CHAM2029 in the clinical setting. And we greatly simplify administration and improve convenience for patients. So with that summary, let's move over to the news flow on Slide 15. So here you can see an overview of expected news flow during the coming year. We are in the final stages of the pivotal line extension approvals in Australia and Europe, where we are only waiting for the European Commission to give a formal approval for the 160 milligram dose. And we are also on track to deliver the remaining milestones in the first half of the year. In the second half of twenty twenty nine, We are 2021. We are looking forward to updating on the progress of our clinical programs, as I mentioned. And also, we are waiting for the start of the registration program of the weekly set melanotype product that is developed by rhythm based on our technology as well as Phase II results for CAM-two thousand and forty three in Raynaud's syndrome. And importantly, of course, we are looking forward to the anticipated U. S. Approval of Briksari. Moving over to Slide 16. We are completing this presentation. Now on my final slide, we have outlined our key strategies for value creation, both in the short and medium term. On the commercial and development side, Chemours is already the market leader with Dovidal in a few markets. And we will continue to build our leading position in Europe and Australia and expand into new markets during the coming years. In addition to that, we are looking forward to the U. S. Approval, as I mentioned earlier, and through that potentially becoming a leading global brand in the opioid dependence treatment area. We have also begun our diversification on the commercial side with prelaunch activities, both in the chronic pain and acromegaly areas. And we will continue investment in our R and D and pipeline development with the goal to obtain both new regulatory approvals for CAM2038 in Chem 2029, but also grow our portfolio of innovative medicines in other areas of high unmet need and Market Potential. On the corporate side, we will look to continue building and expanding our commercial platform where we have done excellent work up to now and add new products. And of course, we're targeting to developed sustained growth over the next few years and also profitability. I look forward to reporting on these further steps of our journey in the next quarterly call on 17th July. So with that said, now it is a good time for the question and answer session, and I will hand over to the call the call to the operator. So thank you everybody for question. Our first question comes from the line of Peter Sehested from Handelsbanken. It's Peter from Heather Banking. And let me start with my apologies the fact that I wrote in my first comment that your revenues were up by 75%. Then of course, SEK 75,000,000 are up by SEK 1 55. So if the share is down for that reason, well, I can only urge to go up and exploit the market efficiently and buy some. But nevertheless, the comment aside, of course, the market is highly interested in knowing About the progress with QuickSight in the U. S, you do make some comments in the report. Part. Can you say a little bit more on top of what is already mentioned in the report? Thank you very much. Well, what I can say is that there is a good dialogue with the agency. And As I understand it, everything is progressing according to plan in terms of the response and sorting out the issues that has been raised. I do believe there is quite a lot of pressure if I look at it from the outside on the agency at this time, But our expectations remain the same. I would also like to say that, of course, there is still a tentative approval for Brickside in the U. S. So the further approval is, of course, just a matter of sorting out this complete response letter and other issues or should be noncontroversial. So we are still expecting the approval to come in the second half of the year, unless something completely different accounts in terms of signals, but that's how we're standing now. Have you any way have you any measures of contacting the manufacturer themselves and finding out what's the actual status on and progress that they are making to rectify those issues that were faced by the FDA. I mean, we are bound by confidentiality here. And to the extent we know anything, I think that what is clear is that every for this. This is, of course, a very important development for all parties involved and every effort is put here. We also know and we have had a third party looking into the questions that were raised in the CRL. So that is public domain information. And we, in our own interpretation of those, Consider them to be addressable within between 1 4 months. So we are expecting things to move forward. But I don't have any further details from this development that I can communicate now. All right. I'll jump back out of the queue. Thank you very much. I'll jump back out of the queue and come back later. Thank Kemmer's. And there are no further questions at this moment, so I'll hand back to the speakers. Okay. With that said, I think I just want to thank everybody listening into our call. It's always an important point of the year to be able to deliver the results of the quarter. And I think I want to especially thank my team for producing such a great result. And all listening in for taking the time to listen to Kemers. And I look forward to following up on the Q2 2 call in July. Until then, hopefully, meet you in other circumstances and have a great afternoon, everybody.