Sedana Medical AB (publ)

Hello, and welcome to today's webcast with Sedona Medical, where Johannes Dolle, CEO, Johannes Spets, CFO, and Peter Sacke, CMO, will present a year-end report for 2024. After the presentation, there will be a Q&A, so if you're calling in to ask a question, please press star 9 on your phone to raise your hand, and star 6 to unmute when you're handed the word. You can also submit any questions in the form to the right. And with that said, I hand over the word to you guys.

Thank you very much. A warm welcome to Sedana Medical's Q4 and full year report 2024. Thank you very much for joining us today. Let's jump straight into the highlights on page three, please. This time, it's even more of a pleasure to present our quarterly report to you than usually, and that is because of the highlight of the highlights on this page. We have received the high-level results also now for our second pivotal trial in the U.S., and they look great. We have met the primary endpoint for both of our Phase III studies, both in the main analysis and across all supplementary and sensitivity analysis, and the safety looks good, too. And of course, it's too early to declare full victory here yet. But these are exactly the results we have wished for at this point. And that's definitely a reason to be very happy about. On the sales side, we've reached a new all-time high for the full year. 179 million SEC means a growth of 17%, excluding exchange rate effects, which is in line with our sales guidance that, if you remember, we have increased during the year. Q4 sales were a bit on the softer side with 10% growth, but it's still the best Q4 that we've had to date with 49 million SEC. We also had great news on the regulatory front. Our pediatric indication was approved. So now our inhaled sedation therapy can also be used for kids in the age of 3 to 17 in the countries where we have the approval, which is so far the case in nine countries. As a pleasant consequence of that pediatric approval, we also got an extra year of market protection for sedaconda isoflurane. You know that we have a big target to turn our XUS business profitable. In Q4, we had a small EBITDA loss of just 1 million SEC, but correcting for warm-up cost, we actually had a small profit. And that despite the softer sales growth during the quarter, this shows that we are very, very close to delivering positive EBITDA XUS, not just in individual quarters, but going forward on a more consistent basis. Gross margin was stable at 71% for the full year and 70% in Q4, if you're excluding the small contract manufacturing revenue that we got for the first time now from our manufacturing plant in Malaysia that we acquired in the end of November. This acquisition will also contribute to building Sedana into a long-term profitable company with all else equal and EBITDA improvement of two percentage points once we have depleted our existing stock and can benefit from lower cost of goods of our main device. At the end of the year, we had a cash level of 194 million SEC. So the cash burn has slowed down apart from the acquisition we've done during the quarter, which was 25 million SEC. And we will further slow down as a consequence of completing the clinical trials in the U.S. So let's start with the great news from the U.S. on page four. Peter, please.

Thank you, Johannes. So for those who have not followed us previously, just a brief recap on the trials. These are two identical phase three trials that we agreed with the FDA for our NDA. And we are aimed to confirm efficacy and safety of inhaled ice-framed virus on the ACV compared with intravenous proper fall standard of care for sedation and other mechanically ventilated ICU patients. and we randomized 235 patients in each study. And the primary endpoint in these studies is the percentage of time at target sedation level assessed with Richmond Agitation Sedation Scale. Key secondary endpoints are opioid dosing during treatment, time to wake up after end of sedation, bones recovery one hour after end of sedation, and the proportion of time during treatment with spontaneous breathing. And as Johannes mentioned, we had the readout from the second trial and communicated this yesterday. The first readout from the first trial was in December. And now we know that both studies were able to demonstrate non-inferiority with regard to the primary endpoint. And we also had a number of, so we had both the intention to treat population, but we have the protocol population and another eight analysis In each study, each of these analyses demonstrated non-imperiority. So we feel these are very robust results, which we're very happy for. Besides that, we've also been following the safety trends during this study. And now we have the total adverse events listing, and we see that this is the therapy that we can collect. is tolerable and we haven't seen any new safety signals compared to what we know from European trials and for isofrenic, which has been around as a drug for over 40 years. When it comes to key secondary endpoints, they are under analysis, and we will be presenting them in connection with peer-reviewed publication. And then we can go to the next slide, please. So as you know, it takes a team to run a big clinical trial like this, and our extended team has been very loyal and hard-working, devoted principal investigators and their study teams and clinical teams, and we're very grateful for all their support throughout these trials. The inhalation of the therapy with isoprene has been very well received. This was novel to them when we started, and throughout the trial, they have come to be very fond of this therapy, and we see now as the results are coming in that we will have these PIs will be our key opinion leaders, and they are already in this space and we expect them to be of great value to us and support our NDA preparations and also be part of the launch which we plan once we get our approval. And then I'd like us to move to the next slide and I hand over back to you, Johannes.