Sedana Medical AB (publ) (SEDANA) Earnings Call Transcript & Summary

Hello, and welcome to Sedana Medical Announces Positive Top-line Results. [Operator Instruction]. Afterwards, There will be a question-and-answer session. Today, I'm pleased to present CEO, Mr. Ahlberg. Please go ahead with your meeting.

Okay. Thank you very much. Also participating in this meeting from Sedan Medical, we also have our CMO, Peter Sackey, who also will present during last Emilio. Welcome all to this short webcast, where we will introduce you and announce the first top-line results from our pivotal registration to de in Europe as a conduct body. But before doing that, I would like to take the opportunity to give you some summary and some recognition of Sedana Medical. So I would like to go to the next slide, Slide 2, where we are defining, I think this is important because this cost top-line results support really our vision as a company where we focusing that INASED situation with our product AnaConDa, that is the delivery device that has been on the market for many years. And it's exiting Europe with loan development, many years of development and research. But still, we needed to have the drug IsoConDa and drug candidate IsoConDa. And these 2 together would definitely have the possibility to become a new global standard of care for sedation in center units. And especially this day, when it comes to isoflurane and IsoConDa study, we have taken a giant leap towards our vision, I would say. So going to the next slide, Slide 3. We are showing that the lock-up the potential of this big product. And as we have already guided, we see a potential approximately of EUR 2 billion to EUR 3 billion annually for this area where we are calculating the market size in number of patients we sedated and ventilated. And the average number of days of 2 to 5 days. With the average price of EUR 100 per day for both the drug and the device. Going to Slide 4. Despite that this therapy is still classified as an off-label treatment. It's obvious that there is a medical need out there within disincent care with the current treatment alternatives. We have seen an increase in the interest of using volatile anesthetics and AnaConDa to sedate patients in the intensive care. And currently, we have approximately 50% growth rate of the rolling 12 months. After the first quarter, we have 9% growth. And we have ultimately so almost 500,000 units anaconda to date. And I mean, has to understand there about hundred of thousand patients have been treated with the treatment. Growing -- and this is not only a German demand. We have seen a huge increase also in markets such France, U.K., Spain, Nordic, Benelux. You go to Slide 5, where we are preparing our self for the full registration in Europe, you can see now where we have our direct sales margin. We are also preparing ourselves to regulatory in the U.S. where you have the biggest market, obviously, but also outside Europe and U.S., we will see net potential in distributor markets that in the rest of the world in Asia, I and here you can see the sales increase during the first quarter. Going to Slide 6. The final slide here is going before going into the next presentation of the study. I mean we have strategic priorities. And the first priority is, of course, to get the product IsoConDa, together with the therapy are fully registered in Europe during the second half year and imparted ourselves to launch it fully in entire Europe. And of course, this study result shows definitely that we are coming very much closer to this strategic objective. Also, we are looking into the U.S. registration as well, and we are working -- peter will comment on that a little bit later also. And also in the other rest of the we have a huge interest in China, Japan, India, and we believe we have denounced a registration of Anaconda. So looking into the financial target, which we have guided you. I can just repeat that. And still, we are saying that 3 years under registration in Europe, we are estimating that we should cover reach approximately up to 10% of the market potential, and that gives you a revenue of EUR 1,250 million and with healthy gross margin, we will also have a very good EBITDA margin on that. So that is the guidance which we have given, and this is European base and then have additional to that we will come back to the U.S. potential and also in the rest of the world. With that said, I would like to go into next slide, Slide 7, and this is all about the IsoConDa study, the high level results, the top line results from our study. And going to the Slide 8. I have before I let Peter continue. I just wanted to give you. I mean, we have already sent out the press release that we have positive top line results. And I would say that this -- the growth that you see here on the screen and that this is indeed 1 of the -- we see the largest INASED sedation study, we've seen intensive care now have finalized into the good results. And this is definitely a milestone in agitation therapy and also interesting to see that how we investigated are really, really interested in this. And they're supporting this and they look forward relate to see that more patients will benefit from the advantages for initiation in the future and to these results. And I also would like to think about this because, I mean, the reason why we started this project from the beginning was to get then transited to the market and to get a fully approved label therapy in place first in Europe. And this result shows that we are we have taken a giant lead towards that possibilities. And I think with that, this work, I will leave that now I will let Peter continue on Slide 9.

So Slide 9 shows different clinical trials that are in to support the approval, I would say, globally, the study is a new one, the IsoConDa study, as you know, completed, and that will be a solid base for the future that is the pediatric study and also for the to U.S. study that will be conducting starting next year. Besides our own studies, we are supporting a number of investigating initiative studies, such as the SESAR trial, which is a study of station in the RDS patients. We have the ISCA trial, which is the study is in COVID-19 patients, at this spring and the INASED trial. That's a study of a patient with incident as an endpoint. So if we move over to next slide, Slide 10. This is where we will be -- this meeting is mainly about registration stats Europe is congested this is a study that was discussed with the German conference authority over a couple of years before starting in 2017, and it's designed to meet their requirements for a registration of Icon Conduct. The study started in Q2 2017 and is a randomized controlled open-label study remining patients in a 1:1 ratio to IsoConDa via AnaConDa or to propofol. And patients was related for up to 48 hours plus 96 hours and followed during that period and for 24 hours also. And then we have 730-days follow-up. So it was completed in January this year, and we plan to submit now after completing the clinical study report and expect to have an approval in the second half year of 2021. The primary end point. Is the portion of time with adequate sedation with Iso-train competitive portfolio, and we have a number of secondary endpoints, which will wake up times, proportion of time with a reading of your requirement and ventilated free days and also number of exposure to move over to the next slide. So the top line results from the IsoConDa study. We move over to Slide 12. A and here, you see the primary endpoint results. We had a high portion at time with sedation at Target RASS minus 1 to minus 4 on the RASS sedation scale in both groups and isoflurane 95% confidence into for me time of appropriate sedation of isoflurane was relatively tight, and what we see here is the blue line, the blue horizontal line, the non-inferiority margin of minus 16% benefit. And you can see that IsoConDa performed clearly well away from the nonincurred margin. So I sites quite robust data. They were approach also with non theoretic testing food strep testing. So we feel confident that these data are solid and will be very supportive for us in our marketing optimization application. one. Yes. That's true because the GSA we have 1 clinical study, and that's why that very important also that these are very significant. We can move over to Slide 13. Which is the safety, we have listing of tourist adverse rents in the RASS, and we didn't see very many of them, and they were in the groups without any basic concerns of tolerability in data. We move over to Slide 14 and show that very many acumen as well as we are when it comes to the secondary electron, the has not been analyzed yet. It will be analyzed in late summer and autumn. And we will be communicating in via publication interiors, potential also some congress. But we don't have those data asset. Now we move on to Slide 15, which is the time line for registration activities in Europe and U.S. as I mentioned, the large patient is included in the SONAR study in January, and we are just now present a high level data. We are starting our pediatric isoflurane study in Spain, Germany, France and Sweden. In the end of Q3, and we expect to submit the marketing authorization application in Q4 in the first round in 2021, the study is to be completed, and we expect to have a marketing approval of IsoConDa in the second half year of 2021. And we should like to have a pediatric market into in 2019. If you look at the U.S., we are currently working with human practice validation program and also with pre-clinical studies, we expect to have an IND approval in simple trial in 2021 and these will be completed and will be submit R&D application in 2023. And that would run here an approval in 2024. 2022, we will determine internally how we will proceed with launch and marketing in the U.S.

Yes. And then I also can comment on the -- I mean the European will importance, not only for Europe, the European study, they decide to come the IsoConDa, but there will also be supportive in investigating the possibility of what kind of studies we will do in U.S. We also will use the dose in Europe for other markets all over the world. And I think that's also a key for us in this because many markets and countries, trust, European authorities, and we can more or less just make -- repeat them and adapt them to let them to the requirement that you have in the specific countries where we want to apply for so I think that is also important for us. So with that said, we now open up our question on Slide 16, you are free to raise all questions you have in mind. Please go ahead.

[Operator Instruction]. And as there are no questions on the bones, and I'll hand it back to the speakers.

Okay. That is -- anyway, I mean, what kind of questions could be raised here. But I mean, I think as Peter said, I have heard during the first hour since after the release, what will happen with the secondary endpoint. And I think that's important. Remember now that we will explore them, and we will actually work to get this study published in a well renovated, as good as much as possible, publication. And I think with that, I think we have got now, and thank you for your interest and support in Sedana Medical, and I also wish you a fantastic summer as well. Thank you very much.

This now concludes the conference call. Thank you all for attending. You may now disconnect your lines.