Sedana Medical AB (publ)

STO:SEDANA

Hello and welcome to today's webcast with Sedana Medical. We have Johannes Doll, CEO; Johan Spetz, CFO; and Peter Sackey, CMO will present the year-end report for 2024. [Operator Instructions]

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 3 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 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 SEK 179 million means a growth of 17%, excluding exchange rate FX, 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 SEK 49 million.

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 9 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 ex-US business profitable. In Q4, we had a small EBITDA loss of just SEK 1 million. But correcting for one-off 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 ex-US, 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 an EBITDA improvement of 2 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 SEK 194 million, so the cash burn has slowed down apart from the acquisition we've done during the quarter, which was SEK 25 million, and we will further slowdown 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 4. Peter, please

Thank you, Johannes. So for those who have not followed us previously, just a brief recap on the trials. These are 2 identical Phase III trials that we agreed with the FDA, for our NDA and -- aimed to confirm efficacy and safety of inhaled isoflurane delivered via Sedaconda ACD compared with intravenous propofol standard of care for sedation of 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, point of recovery, 1 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 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 intention to treat population, we had the protocol population and another 8 analyses and in each study each of these analyses they demonstrated non-interiority.

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 the study, and now we have the total adverse events listing, and we see that this is the therapy that we can claim as tolerable. And we haven't seen any new safety signals compared to what we know from our European trials and for isoflurane, 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 a very loyal and hard-working devoted and principal investigators and their study teams, and clinical teams and we're very grateful for all their support throughout these trials. The inhaled sedation of the therapy with isoflurane has been very well received.

This was novel to them when we started, and throughout the trial they have been -- 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 corporations and also be part of the launch, which we plans also get our approval.

And then, I'd like us to move to the next slide, and I hand over back to you Johannes.

Thank you, Peter. Then let's move to Page 6 where we already are, perfect. This shows the longer term sales development. We've shown that slide for a while now, as it shows nicely our progress over time. The one disturbing thing has always been that the COVID years, especially 2021 were towering above all other years, that has now come to an end. 2024 marks a new all-time high in sales. If you followed us for a while you know that this is the result of a fundamental transformation of the company, starting with a streamlining of all our non-customer facing functions to free up cash to invest into the front line, especially in countries where we have good profitability and momentum. And it's the result of a strong focus on commercial execution as well.

If we then go to Page 7, the sales growth that we've just seen combined with a simultaneous focus on driving cost down, has resulted in a significant improvement of our profitability situation. 2022 was the year with the biggest EBITDA loss in Sedana Medical's history. And now in 2024, we've actually had 2 quarters with a positive EBITDA outside the U.S.

In Q4, reported numbers still show a small loss of SEK 1 million. But we also had some extraordinary costs related to the acquisition of Innovatif Cekal mostly legal cost of course, and also some cost related to creating a pricing and reimbursement dossier, for the pediatric indication in Germany. So cost items we would not normally see in the normal course of operations and excluding those, we actually had a small profit. For the full year, we still had a loss of SEK 15 million outside the U.S., which is also a good improvement from minus SEK 40 million at the year before.

On Page 8 as a quick recap, let's talk about our acquisition of our main supplier in Malaysia, Innovatif Cekal, which we closed in the end of November. So during the quarter for me this acquisition is an important building block towards building a long-term profitable company. So let me briefly recap what we have done, and what will be the impact. So we've bought our main supplier based in Kuala Lumpur in Malaysia. Main supplier means that they are not our only supplier, but they manufacture our main medical device, Sedaconda ACD and also certain accessories such as adapters, and therefore they represent a pretty sizable part of our cost of goods. The purchase price was SEK 34 million, 75% of that we've already paid upon closing, and 25% have been deferred by 2 years.

There's 2 important reasons why this is a good deal. Firstly, we gain control of the supply chain of our main product, so we are less subject to price variations, are in control of future scale up of the capacity to meet our growth plans. And over time we can also implement measures, to further enhance the productivity and not least of course also make the factory audit-ready for the FDA, once we get closer to the U.S. market.

Secondly, we are expecting to add 2 percentage points to our EBITDA, once the existing stock is depleted. So I see this as a logical next step in building a long-term profitable company. In addition, we'll enjoy a small, but positive cash flow from supplying Innovatif Cekal as second customer. We've paid for the transaction out of our existing cash. The deal will be paying back quite fast. We expect a positive impact on our operating cash flow already from this year, and we should have a net positive effect from 2028 onwards. Importantly, we continue to be financed to execute on our plan also with this acquisition.

So let's sum up the performance in 2024 on Page 9 please. We had guided for 14% to 18% sales growth for the full year, and then we raised that guidance to 17% to 20%. We've now landed on 17%. So within the guidance, albeit on the lower end, and importantly, we've also lived up to our ambitious target, to deliver positive ex-US EBITDA during the year. We've managed to get there in Q1 and also in Q4, as we as we just discussed.

Let's turn to the next page, Page 10 please. Based on the solid performance in '24, we are aiming even higher in 2025. Our view on the market potential, which you see on the left side here is unchanged. In our prioritized regions, we still see 3x the size of the addressable market in the U.S. compared to the markets where we operate today. But more short-term, in 2025, we want to deliver a positive EBITDA ex-US for the full year in the low to mid-single-digit margin range. And we will do that, by continuing on our growth trajectory that we've established now over the last 2 years, and of course also continued discipline on the cost side.

Good. So maybe let's do a double click on our sales performance and look at our regions on Page 11. You will see that our other direct markets have been a strong growth driver for the company both for the full year and also in Q4. In the fourth quarter, this group of countries delivered a growth rate of 45%, and they now represent pretty exactly 1/3 of our overall business. And coming from a situation where Germany has historically been the absolutely dominating market for the company, we've really made it a priority to increase our dependence on Germany, and bring more countries to high levels of penetration and we're very well on track for that.

So if you look country-by-country, Spain continues to be our strongest market outside Germany. The team there is very successful in making more and more hospitals use our therapy more broadly, so in more and more patient indications. And as simple as that sounds, that element, establishing broad use in a lot of patients in a given hospital, is really the core of our commercial focus. And Spain is a prime example for that. If executed well, it really leads to great results. For several years now, we followed a very disciplined investment approach where we extend teams that show profitable growth, but also go the opposite way. So cut back investments where this is not, or not yet the case.

In Spain, of course, we have increased the team size to keep up with the strong growth, and also further accelerated. In the U.K., we've also seen a significant increase in demand during 2024, from a lower level, but still very, very nice growth and now also slightly expanding the team to strengthen that momentum further. In France, you know that we've had quite flattish development for a while, due to different reasons, mostly related to stability in the team, which made it necessary to restructure the team and the territory structure. But we've now seen a very good Q4 actually with some robust growth, with which we are of course working on maintaining.

If we then move to Page 12, let's turn to Germany, still our largest market with just above 60% of our sales. We've had an okay year, but not a great year. We've grown 5% year-over-year and had a flat Q4. What's behind the full year performance was a relatively weak Q2 at the time, driven by an unusually low number of patients in June and now also a flat Q4. And the reason for that, is mostly that we had some turnover in the field force leading to temporary vacancies in select territories, and some time that was needed to onboard new colleagues, which is a bit of a longer process until they're fully up and running. And our therapy is very sensitive to promotional activities, and presence with customers, how much time we spend in the field.

So these kind of disruptions that sometimes happen in a field force can easily impact the growth in a given quarter. So 5% for the year. Let me be very clear here. 5% growth in Germany is not where we want to be. We want to and can grow faster than this. And we already implementing a sales acceleration plan together with the local team, which is actually already starting to show an impact today.

For me it's very important that it becomes very evident again that we are not yet reaching a plateau in our main market. We had 13% penetration in 2024, which good. But we still have room to grow in light of the clinical and health economic benefits that, our products bring both to patients and to intensive care units.

And we know that in our best performing sales territories in Germany, we had average penetration levels of quite a bit more than 20%. And these territories are still growing, so there's still a lot of room to grow also from a national average perspective.

Then let's move to Page 13, to our distributor business, which represented roughly 5% or 6% of our sales in Q4. Of course the strategic focus is on our direct markets, given the share they represent in our business. But it's still nice to see that we had the first full year growth in our distributor business since 2021. Actually we are pursuing a very focused approach, with a lot of emphasis on a few key partners and high potential opportunities.

But that business is always going to be inherently a bit more volatile as ordering cycles are much longer, and as a consequence than inventory levels kept at distributors, tend to be much higher than at hospitals. So depending on, which side of the quarter a certain order will fall, we will have somewhat varying performance as we also saw in Q4 where we declined by 28%, which sounds more dramatic than it is. It's really mostly the timing of orders here, but again, we are moving in the right direction generally with a 15% year-over-year growth in that part of our business.

Then let's move to Page 14, please. Some great news, as I said on the regulatory front. In December, we received the decision that all the different involved countries have reached consensus that our pediatric indication can be improved. Since then we have received national approvals in 9 countries. What this means now is that our drugs for inhaled sedation can also be used on label for kids between the age of 3 and 17. It's not a huge patient group, but it's a very vulnerable patient group. And so far only midazolam was approved for sedation of these kids in the ICU, which comes with a lot of complications.

As a very positive side effect, the CMDh, which is the group working with EMA that is responsible for these things, granted us an additional year of market protection. So we now have the maximum market protection that you can get, 11 years in total, which will last until 2032. Market protection means that during that period, no company can launch a generic for inhaled sedation in the ICU in the countries, where we have that approval and that's good in itself.

But it was also very nice to receive the argumentation for this extra year as the authorities stated that our new expanded indication represents, a significant clinical benefit over existing therapies, which we could not have phrased better in our marketing materials. One of the drivers here is probably that in the clinical trial IsoCOMFORT that is underlying this approval, we saw a 50% reduction of opioids, which is an even more significant reduction than we saw in the adult indication in Europe.

Let's move to page 15 please, and switch gears to the United States. Again, as you know the U.S. is our largest growth opportunity and one of the reasons, why we are so focused on turning the ex-US business profitable, as we want to be able to launch in the U.S. based on a stable platform. In Europe, and a cash generating business over here. We've estimated the U.S. market potential for our products to be roughly SEK 10 billion to SEK 12 billion, which is 3x times as much as in our current direct markets combined.

And this is because of a higher number of ventilator beds, but also a medical practice that favors incubation and mechanical ventilation more than in Europe, and also a slightly, or not slightly, an overall higher price level in the U.S. We see a very good product market fit, which I will talk more about on the next page, but on top of that, Peter and his team have done a really, really good job in building a network of key opinion leaders in our clinical trial sites.

Who, as you've seen, some of the premier names in the U.S. hospital landscape here that are very supportive of our therapy, and already very active promoting or beating the drums for inhaled sedation in a different global conferences. So we have a high market potential, a good market product, fits, a KOL network that is eager to get started and positive high level results. And therefore we continue to believe that we can create the most value if we launch ourselves in the U.S. capture more of the upsides. And generates proof that this therapy can be successful in the U.S. while of course over time keeping the option open to complement our presence with a partnership if we deem that to create even more value, but plan A is to grow this ourselves.

I've mentioned the product market fit, so let's have a closer look at that on Page 16 please. We know that our inhaled sedation products have fantastic clinical benefits for patients. We've seen that for several hundred thousands of patients in a lot of hospitals in a lot of countries. But the truth is clinical benefits alone, are no guarantee for a product to be successful on the U.S. market.

And the commercial success very much also depends on how well the product fits with the healthcare system. So we've done a deep dive into that with a focus on reimbursement, payment structures, etc. Together with an expert consulting company. And of course we've been bullish about the U.S. before, but that work has made us even more optimistic.

There are different payment mechanisms for hospital in the U.S., but by far the dominant one for mechanically ventilated patients in the ICU is DRGs, so called diagnosis related codes. So what that means is that a hospital gets paid a preset amount for a given patient, depending on what diagnosis and partly also procedures that patient will have. This means that from a hospital P&L perspective, the revenue side is fixed, and the cost is dependent on how much, or how long a patient is in the ICU.

So a therapy that could potentially help the patient wake up faster, spend less time on the ventilator, recover faster, leave the ICU earlier, will have a positive effect on the hospital's financials. Now I cannot say that Sedana will be able to provide those benefits in the U.S., because we have to await the approved label by FDA. But we have shown these things in our European trial.

What we also know from our European trial is that inhaled sedation patients needed less opioids, 30% less in SED001 so the European approval trial, and even 50% less in our kids trial without these patients experiencing more pain. And the U.S. as you know, is extremely sensitive to avoiding opioids, because of the terrible opioid addiction epidemic and more than 100,000 people each year dying from overdoses. And of course the FDA is very aware of that and very sensitive to that as well. So bringing a therapy that might reduce, the use of opioids in a vulnerable patient population would be a major plus on the U.S. market as well.

What we also know from Europe is that treatment guidelines, treatment recommendations, can play a crucial role in facilitating the uptake of our products. If you read for instance what the CDC says about mechanical ventilation in their Wake up and Breathe collaborative, it reach very much like the benefits that inhaled sedation has shown in the past. So this is very much about getting patients off the ventilator sooner, improving recovery time, shortening ICU stays and so forth. So if we manage to confirm these results in our U.S. study that we saw in Europe, we'd be fitting right in, and we would be very well positioned to get inhaled sedation reflected in treatment guidelines.

So then let's move to the next page, and I'll hand it over to Johan for a little deep dive into the financials.

Thank you, Johannes. Yes. So let's continue on Slide 17 with some more details on our financial result in the fourth quarter of 2024. Johannes has already mentioned some of these numbers, but it's worth reiterating the highlights.

So net sales for the quarter are SEK 49 million that's up 10% compared to the same period last year. Johannes mentioned the main drivers here. So Germany where sales were flat in the quarter, driven by some temporary vacancies and some that transition situations in the second half of the year. The other direct markets continue their strong growth 46% year-over-year in the quarter or 45% excluding FX. And again this is driven by very strong performance in Spain, U.K. and also France rebounding in the latter part of the year.

Our distributor markets, decreased sales for the quarter. But we know that that part of our business can be volatile quarter-to-quarter depending on order patterns. So what's very reiterating to see is that, we are reporting full year growth again for our distributor markets, which is the first time that we do that since the pandemic years.

Gross profit for the quarter of SEK 34 million that's up from SEK 31 million in the same quarter last year. So that gives us a gross margin for the quarter of 69%. If we exclude the slight headwind that we get from now having contract manufacturing in the group since the acquisition of Innovatif Cekal, we would have had a gross margin in the quarter of 70%. So that's what we will try to stay at, or above for our core business.

Perhaps worth adding there that once the existing inventory of products is depleted, we will start to see the benefit from the lower COGS for our ACD in particular coming from the acquisition of Innovatif Cekal. We expect that to come through in the reported numbers also starting in the second half of this year. So while there is a slight headwind in terms of the gross margin in the near term from the acquisition, we expect that to change going forward, and that this acquisition will be accretive over time as we grow as Johannes has said earlier.

In terms of EBITDA, we report negative SEK 5 million for the quarter at the group level, that's an improvement from negative SEK 9 million in the same period of last year. And if we look at EBITDA excluding U.S., we report a very small loss of SEK 1 million for the quarter. That's a clear improvement from negative SEK 8 million in the same quarter last year.

And as Johannes already mentioned, if we exclude certain one-off costs related to the acquisition of Innovatif Cekal and also our pediatric approval in Europe, we see that we have a slightly positive EBITDA excluding U.S. in the fourth quarter of 2024, which is again a clear sign that we are turning the business profitable. We are improving EBITDA over time here, with growing sales and continued cost discipline. And that's also of course behind our new financial target for next year. Where we guide for positive full year EBITDA margin excluding U.S. or low to mid-single-digit margin excluding U.S.

In terms of our staff and the organization. After the acquisition of Innovatif Cekal, we've grown the number of employees and consultants. But important to highlight there is that if we look, if we exclude Innovatif Cekal, we can see that Sedana Medical like-for-like so to speak, had a lower average employees and consultants in 2024 compared to the previous year on average.

Then if we turn to the next slide, please Slide 18 and look at our cash position and cash flow for the quarter. So cash at the end of the year stood at SEK 194 million that's compared to SEK 226 million at the start of Q4. So this change in cash of negative SEK 32 million for the quarter was driven by CapEx mainly in the U.S. And of course, we also had the acquisition of Innovatif Cekal so CapEx of negative SEK 30 million and the acquisition of Innovatif Cekal negative SEK 25 million net. Those negative items were offset by cash flow from operations positive SEK 7 million c and an FX effect on our cash balances that we hold in U.S. dollars of another SEK 16 million positive. So that's, that's behind that drawdown in the cash position in the quarter.

If you look at the, the actual cash flow as such, cash flow from operations for the quarter, As I mentioned, SEK 7 million, that's positively impacted by received interest of SEK 12 million during -- the quarter. Then we have, as I also mentioned, cash flow from investments in total negative SEK 55 million. That can be broken down into CapEx, mainly related to our U.S. submission preparations, and then the acquisition of Innovatif Cekal, which is SEK 25 million out of those SEK 55 million.

So total cash flow for the quarter negative SEK 49 million, but again if we had not done the acquisition of Innovatif Cekal, it would have been negative SEK 24 million. So there you can see that the cash burn that we have as a business, is being reduced now. And of course the main driver behind that, is fact that our U.S. clinical studies have now been finalized, and we see that CapEx now for 2025 will be significantly lower than for 2024.

So also in terms of liquidity management, we continue to hold a lot of our cash in U.S. dollars. So now approximately 75% of our available funds are in dollars, and again we expect to be fully financed to execute on our strategic plan leading up, to approval in the U.S.

Next slide, Slide 19 just shows the updated shareholder list, and of course we continue to be very grateful for the support from our main shareholders on our journey forward.

And with that I will hand the word back over to Johannes.

Yes, only one more slide, Page 20 to wrap it up. Let's take a step back and recap the investment case for Sedana Medical. So business model as you know, lends itself to attractive profitability over time and that's for 2 reasons. We continue to see good gross margins of 70% and up 71% for the full year of '24. So by definition we can become quite profitable as a business when we reach scale.

And our customers are intensive care units. So a relatively small target group that we can cover with reasonably operating expense level on a local level. And we already have proof-of-concept for that in our main market Germany, where the majority of ICUs are already our customers today. The team is generating very attractive EBITDA margins on a local level. We also see great momentum outside Germany as we've talked about. And while we are not at the same scale yet, most of our countries contribute positively with local profitability by now.

So we have the proof-of-concept, and now it's all about reaching scale. So convincing enough hospitals to use inhaled sedation more broadly, and achieving profitable growth. And hence we are quite optimistic about our growth opportunities. We have very convincing clinical data, good health economic data on our side, showing that patients really benefit from inhaled sedation, and that at the same time hospitals save money with inhaled sedation versus the previous standard of care.

And we have lots of places to grow, both in Europe and hopefully soon also in the U.S., where we have a fast track designation from the FDA. And now of course, the positive high level results that we got in both U.S. trials, provide for an extra motivational booster and hence importantly, as Johan just mentioned, SEK 194 million in cash still and a good reduction of the cash burn ahead, following the completion of our clinical trials in the in the U.S. So that's the presentation.

Thanks again for listening, and we'll be very, very happy to take your questions.

And the first caller in here is Filip Wiberg from Pareto.

So just a few questions here from my end. The first is on Germany and if you could just expand a bit on the reason for the flat growth here. So you mentioned that you had reduced field presence following the staff changes, and also some temporary vacancies. So just wondering, were there like major changes in the quarter, or does it mean that you are quite sensitive to small changes that are going on in the organization?

Yes. Okay, so you said you had several questions, but let's take them, let's take them one-by-one.

Yes.

Yes, so you're exactly right. So we had a bit of turnover in the field force, which I mean is normal. Of course. people don't stay forever. Either somebody resigns or we have a performance issue and we have to ask somebody to leave. The way that is affecting us is that's our field force is relatively small, right. So in Germany we have a team of 10 sales key account managers in 10 sales districts.

So if you have a change in 1 of 2 territories that can easily have an impact. And what's happened here is simply that 1 person resigned and 1 transitioned into a different role within Sedana, and then you have to replace those positions. And that is typically a process that takes a little bit of time, because it's not an easy job, right. So our therapy is great, but it doesn't sell itself.

These people need a lot of medical knowledge. They need to know exactly the ICU infrastructure, they need to know every ventilator model, every pump model and so forth. So there's a bit of a learning curve that you have, to go through when joining Sedana. And we've seen a little bit of that effect during Q4. That's temporary, I would say, because we have a very strong team in place.

We see that in territories where we have continuity and people in the field that have built very strong customer relationships, over a long period of time, then we can get well beyond the 13% national average that, we have in terms of penetration in '24. And we had a pretty good start to the year also. So I'm very optimistic that we will see an acceleration here again.

Okay. That's a great answer. Yes so, as you said, obviously it's a great part of Germany still to penetrate. So you had some sales acceleration plan. So could you give some more details about what you've done here, and what you're doing during the year to increase the growth?

Yes, no, of course. Now, I will maybe not go into too much detail here, but where you typically want to focus, is to make sure that you have as much presence with the right customers as possible. And then if you have that time with customers, you ask as convincing as possible. So we are very much looking at the how we're targeting accounts.

We're very much looking at how we can increase the time in the fields, how to make sure each key account manager receives the best possible coaching, how do we provide them with the right training? And then it's a lot about focus. We have a lot of customers in Germany, so more than half of the ICUs are our customers already. Every key account manager is handling quite a long customer list.

And usually it's easier, to really focus on a few accounts where you can make a real difference, and establish inhaled sedation as a mainstay therapy, maybe coming from more occasional use, as opposed to trying to make every customer a little bit better in terms of penetration, right. So there's a lot of focus. None of this is revolutionary, but sales has a lot to do with discipline and execution, and that's where you typically get the results.

All right. Okay. And perhaps moving on then to the guidance of 2025. So now you did not give any specific sales guidance, but you mentioned that you're targeting EBITDA breakeven ex-US for the full year. And that was built on an assumption that you're going to continue, this trajectory in terms of growth that you've been on. So what do you mean by that? Is that to continue growing at a rate like this year, so 70% or what does it mean?

Yes Filip, you're a great analyst. I'm sure you will figure this out. So joking apart aside, so we, I mean the big, big target that we have from a strategic perspective is to make sure that we have a European business, or an ex-US business that is profitable and that generates positive cash flow. So we have a stable platform for the launch in the U.S.

So given that that is the, the main priority here, we kept it simple and said, we'll deliver a positive EBITDA ex-US and we in the low to mid-single-digit range. So if you run these numbers, it will become quite clear that that is not possible without growth. Of course, we will continue to be disciplined on the cost side, but we will need to continue to grow. We had 16% growth last year. We had 17% in '23 and then 17% in '24. So it would have to be, if you run the numbers around that range but we're not giving a growth corridor this time but focus on the EBITDA target.

Okay. And then just on trial results here, so very encouraging to see positive top line for both. I didn't really think it, don't think it came as a complete surprise that the second also came out positive. But now going forward, like from my end, it seems like the probability of reaching the market is very high, given the positive top line results from both trials and also the European trial. But I'm just curious from your end, like what are the risks that you see that are left for approval and what could go wrong?

Yes, that's a very optimistic question. So I mean, we have to be very honest, right? So if you're dealing with the FDA and if you're trying to bring a new product and in this case a drug device combination to the U.S. market that is not risk free. Now we've taken a big step, because we have the positive high level results in both studies.

So primary endpoint met. So we have non-inferiority established and the safety looks good also. And that's kind of very clear results. So there's no room for interpretation that there is - everything is within the non-inferiority margin that we've agreed with FDA. All the sensitivity analysis, all the supplementary analysis, everything looked good. So there's no mixed results here. So that's of course a big step.

And these two primary endpoint. So does it work? And safety, so is it safe? Is going to be what the FDA will mostly look at from -- to take the approval decision. Is this approval yes or no? So great step. At the same time there's still a lot of data that will come right. Secondary endpoint, which is probably less relevant for is it approvable? Yes or no. But it will inform what kind of a label we will have and what kind of claims we will have, right.

So that's the FDA decision in the end. But then there's a lot of parts of the dossier also that deal with the device, that deal with human factors studies. So making sure that all of these devices can be handled, by hospital personnel. You need to make sure that all the extractables and leachables tests and non-clinical tests and all of that looks good. There's nothing where I would say, we have a huge risk here or there's a major red flag.

But then again we only have the approval, once we have the approval. And when you look at why companies fail, or have to do an extra round, so get a complete response letter. If you look at the recent examples, very often that has something to do with quality, or manufacturing or third-party suppliers and so forth. So you have to cover the entire value chain to make sure everything is in order.

And here the acquisition of Innovatif Cekal, I think is also a way of derisking the file, because if we have that under control and we can make the changes to the factory that we believe are necessary for the FDA to be happy in an audit should it come, that's much easier to do than trying to do that, if you don't own the factory. So is it risk free? No. Have we taken a big step? Absolutely. And the remaining risks we're trying to mitigate and derisk to the best of our ability.

Okay. That's a very good answer. And then just lastly, perhaps an easy question, but the feasibility study, do you have any update around that, how it's going?

Yes. So maybe just for context what's a -- in the last quarterly report, we had communicated that the FDA had recommended us to include the European trial with the American file. And not just do that, but actually run an analysis across so pool -- statistical term pooling the European trial with the U.S. trials. And at the time, we talked about that a feasibility study is needed to see if that's technically feasible, because the studies were similar, but not the same.

So different data formats, different definitions, different measuring time point measurements and so forth. So that this feasibility study has been completed, and we can essentially progress as we have planned. So it is possible to pool all the endpoints that we want to pool. So we are implementing the plan as we wanted it, meaning that we'll pool quite a few of these efficacy endpoints to live up to the FDA's recommendation.

We will now carry on and hand over the word to Mattias from SEB.

Just a quick follow-up on the question on Germany that you received earlier. Did I recall it correctly that you know this will not have a lasting impact on Q1? And also if you could comment a little bit on how activity and so on the ICUs overall in your end markets have [ start shuffling ] in Q1. That's the first one?

Yes. So I would say the sales acceleration plan is underway. We're starting to see early effects from that. As always, I would be a bit cautious to over interpret individual quarters, right. Also in Germany last year, we had a very strong Q1 followed by a weak Q2, then a good Q3 and then a soft Q4. So it's a bit volatile simply given the seasonality in the business and also then the flu seasons and others.

So the more important thing to look at is, I think are we moving in the right direction over a longer period of time. But I would not expect Q1 to be to be negatively affected on the contrary. I think the things are going quite well, in terms of activities in the ICU seasonally, as you would expect. ICUs are quite full right now. There's a lot of flu and flu cases in several European countries. It's not an extraordinary year in that sense. So it's not like, don't compare it to COVID, but it's seasonally normal full ICUs. So as you would expect Q4 and Q1 be our stronger quarters.

That's clear. Then I think I've asked this once before, but maybe you can talk about it a little bit more. So if you could spend some time to talk about what can be done here, and if that view has changed in order to make the sites in the U.S. continuing to sort of use or you know. Yes, use the therapy on patients here in the period between now and you get approval, or potentially approval in the U.S., because I think that's interesting. So that's the second question?

No, that's a very relevant question, because we've built this great network of supporters in the U.S., right. So of course you want to make sure they keep the excitement all the way to launch. And with all the dossier preparations, and the long-term follow-up and the review period, there's quite a long time period between ending the study and the commercial launch.

So how can we make sure that we keep the excitement up? And part of that of course has to do with more medical affairs type activities. So making sure you keep the relationship. A lot of these investigators are very active in speaking at conferences already, connecting with European leaders across the Atlantic. So being very, very close to some European opinion leaders, to become part of that global community.

But more hands on. What could potentially be an option? I'm saying could, because it's not clear yet. I mean, the study is over, right? So right now nobody can use our therapy. There is however, pathways in the U.S. to continue using the product. So if you have a normal clinical trial for, let's say an oncology drug, it's quite normal that if a drug works on a patient.

Then that patient will be allowed to continue using that drug even when the study is over. We don't have that possibility, of course, because it's intensive care patients, right they don't stay in the intensive care unit forever, hopefully. But there are things like the early access program EAP, which has to be approved by the FDA. When there's no great alternative for certain patient groups, which you could argue there are patients that either don't tolerate propofol IV very well, or it's very difficult to sedate them.

Because they've developed a tolerance. Then there's no great alternative today. And in these cases, the FDA has a pathway -- for these sites to use new products with a certain protocol, before the actual approval and that we are in discussions with the FDA, and trying to get that approved. Whether it will work out, let's see. But that is one way of trying to keep the excitement and the usage up.

And then my next question is regarding the SEK 30 million extra costs in the sort of pooling and complete ISE and ISS, as you discussed in Q3, these documentations. So in terms of these costs just to make it 100% clear. Where will those costs be recorded in your reporting?

Those will be U.S. CapEx. So they will not appear in the P&L, but capitalized to the balance sheet.

That's completely clear. And then if you could talk a little bit about, I imagine you haven't close no exact amount in the past, but in terms of U.S. OpEx and yes, just how we should think about the organization build up and so on here going forward. Maybe a few words on that?

Yes. So I think we've talked about that before to some extent. So as a small company you have to strike that balance, right between making sure you start launch preparations early enough so you don't miss the boat. But at the same time you can't build a big organization way ahead of launch, to make sure that you don't destroy your finances.

So we have a target organization in mind, what we would like our U.S. team to look like when we launch. And then there's a build-up plan over time. And most of these investments would come relatively close to launch. So the majority of people would be field-based salespeople, or field based medical people. Those you would hire relatively briefly before the launch such that you have enough time to train them, and for them to get familiar with the territory.

But you wouldn't want them sit on the P&L 6 months before the launch, because there's not a whole lot you can do in the U.S., because the rules are of course very strict. As long as you don't have a label, you cannot sell. So from a U.S. OpEx perspective this year, you will not see much impact of that build-up. We have a small team in the U.S. already, which we will keep, but the expansion will then happen closer to launch.

Then I have 1 more question, if you could talk a little bit about your view key risks to let's say not be able to file with the FDA for approval in the beginning of 2026. As it stands right now, what authority sort 51.19of hurdles to go wrong]?

What are the key hurdles? So one thing we have moved out of the way. So the primary endpoint and the safety look very clear. So had those been mixed, or had those been raising question marks then of course that creates extra work. Then you have to go into the data more deeply, run additional analysis and so forth. But that's kind of the data as such, essentially exactly as we have wished for.

So that is not an issue. We will get more data, right there will be secondary endpoints, there will be the long-term follow-up, there will be the pooling analysis and so forth. I'm not expecting any problems there. But of course, if we have anything come up here that triggers us, to have to put more work in, that could be a little bit of a risk. And then of course, every time we interact with the FDA. They might come with additional questions, they might come with additional demands.

As had happened when we talked about the pooling analysis, right. And that's we, I guess, have to be humble and say that that is a possibility. So in every FDA process, there's things you have under control and there's things you do not have under control. And the things you do not have under control is usually FDA related. But again, with, with these positive data in both studies and the high level results, that's already a big step forward.

And we will now carry on with some questions that have been sent to us. You seem to have good momentum in the U.K. with NIC recommendations and health economics data. But what is the status around reimbursement?

Yes no, that's true. So we got MHRA approval in the end of '23. Since then we've seen a great pickup in demand. And also we have a team that is very active and very, very focused on execution reimbursement. We have to differentiate between device and the drug. The U.K. tends to be relatively easy, because you have only one customer with the NHS, so it's a less complex process.

The devices you sell to hospitals directly, with a certain price list. So there's no national pricing and reimbursement process that you have to go through. And the same goes for the drug. So there's no - in some countries, like for example, Spain or Germany, there's a fixed process that can take a year, or even longer where you have to submit big dossiers and so forth. That is not the case in the U.K.

Launching in the U.S. is some years away, but you seem confident in launching there yourself. How should investors look at the possibility of a larger equity during next year, to give you the financial muscles that I suspect you need for such a journey?

Yes. So I'm assuming that's supposed to say equity raise if I interpret the question correctly.

Yes, I believe so.

So we've been quite clear about that, I think. So we want to be in a situation that we are not forced to raise more money. So the way to think about the different components here, there's 3 parts that matter from a cash flow perspective. One, is the core business outside the U.S. So that one, as you've seen, we are making progress towards making that profitable.

We already had a positive operating cash flow in Q4. We've just communicated a new target for next year that we want to be EBITDA positive ex-US so that part of the business will start generating profits and positive cash flow. So that's one. Then the second big part from a cash perspective is the U.S. capital expenses or CapEx. The investments mostly in the clinical trial, those have been extremely high.

So that was the main source of our cash out historically that is now coming to an end. You still saw some of it in Q4, but going forward these expenses will be limited, to the activities we have around preparing the dossier, and the pooling analysis we talked about and so forth. So that source of cash out will decline quite a bit. And then the third component here, is the actual launch investments, right.

And that is under our control. We are planning to go it ourselves, but in a relatively targeted way focusing on territories around our clinical trial sites. So where we already have good support. And then once we have proof-of-concept, we can scale that up, and these 3 pieces taken together, that math checks out, so we can finance that out of our own strength.

We still had almost SEK 200 million on the bank account. So we are not planning for a capital raise. Of course, I'm not saying that the company will never take in money again, if we feel like we can create more value if we invest more. Maybe it's currently not in the plans, but what's very important for me is that we don't end up in a situation, where we have to raise money, because that's typically not to be a nice spot to be in.

Are we still expecting to see benefits of the supply chain acquisition in H2 2025, meaning increase in EBITDA margin?

Yes. Short answer, yes. So the financial impact of that acquisition is we have a small contract manufacturing revenue that comes in. We've seen that for the first time in, in December. That's of course at a lower gross margin than our core business. But in the phase where we are right now, of course every positive cash flow is welcome. So that's a bit of a negative effect on the percentage gross margin. Positive one on the absolute gross margin of course.

And then the big effect comes in once the stock is depleted. And we enjoy the lower cost of goods of our main device, and some accessories and that we're expecting, to come through in the second half of this year. And yes, if all else equal, because of course there's other things affecting the gross margin as well. But all else equal, these 2 effects -- would lead to an improvement of roughly 2 percentage points. Yes, so that's still unchanged.

How do you see U.K., Spain and France growing into Q1? Is there a continuation of the current trends?

Yes, of course. I don't want to speak too much about how January and February has been going so far, but there's no reason to believe that there's any change in the momentum. So I'm very much expecting that growth to continue, not just in Q1, but beyond that as well.

Can you speak to any other markets where you are seeing an increased interest in Europe that might help drive growth?

Yes. So maybe the one thing I will say is I think in a company like ours, focus is really important. So of course, we've been selling our products in 40 countries, and there's a lot of patients around the world that could benefit. But we're very, very focused on Germany, Spain, France, U.K. These are the markets where right now we believe we can grow the most.

But besides that, there's a lot of countries, also distributor countries where we see a lot of potential and also good global momentum. Austria as an example, Slovenia as an example. Italy is an example. Countries in South America are examples. But from where we have the focus that's really around the countries that we are communicating around.

Why are you not delivering any guidance on the 2025 number when it was done for 2024?

Yes, I think I answered that question before. So the very big focus is on delivering a positive EBITDA from the ex-US business next year. We've grown 16% in '23, 17% in '24. And we are assuming that we will continue to show growth on that trajectory. And if we succeed to do that, then we will end up with the EBITDA guidance that we have -- that we have given out.

Moving on to the last question here. Why are you so conservative about pricing in the U.S. average pricing for sedation in U.S. is much higher than European prices?

Yes. So what that is referring to is we are giving an addressable market estimate for our direct markets in Europe, and for the U.S. and the result of that is that the U.S., even without assuming a big price differential, is 3x higher than what we have in Europe. What's true is that medical devices, in general, are priced quite a bit higher in the U.S.

If you look at things like propofol used for sedation in the ICU, those prices -- the price differentials are even higher if you compare net-to-net. So definitely there's a pricing upside in the U.S. Whether we can charge more than in Europe will of course, also depend on the clinical trial data, on the label that we will get, etc. So it was really as the question already kind of answers is a conservative assumption. Of course, we will be trying to set the price such that is most value, at least for the company.

Thank you so much. That was all the questions we had. So thank you for presentation and thank you all for sending in questions and seeing us today. Have a nice day.

Thank you very much. Have a nice day.