Thank you for the introduction. Warm welcome to our Q3 report 2026.

I'm sitting here with our CFO, Mikael Haag, who will take you through our financials in a few minutes, and our CMO, Peter Sackey, who will give you an update on our progress in the US. Two things stand out for me this quarter.

First, of course, the FDA has accepted our New Drug Application for review, and has set a PDUFA date on April 16th, 2027. Our biggest growth opportunity, the US, has moved another important step closer.

Second, we are back to growth. After a flat first half of the year, group sales grew 7% at constant exchange rates in the third quarter, with Germany improving considerably, and all of our other businesses continuing to grow.

At the same time, our cash burn came down quite significantly, now that the intensive submission phase is behind us. Let's jump right in.

On page three, you see the highlights structured around our three priorities: growing sales in our ex-US business, reaching profitability on a company level, and our US journey. Q3 net sales were 44 million SEK, up 7% from last year at constant exchange rates.

That actually makes it the best third quarter we've ever had. Keep in mind that Q3 is seasonally typically our weakest quarter, with fewer respiratory patients in the ICUs, and also summer vacation affecting the results.

The biggest swing came from Germany. After a decline of 18% in the first half of the year, we are now at -2% in Q3, very close to last year's levels.

I'll go into what's behind all of that in a moment. All of our other businesses continued to grow.

Other direct markets were up 11%, our distributor business is up 27%, and contract manufacturing was up 47%. The latter, the contract manufacturing, was helped by a shipment that was delayed from June to July, which I mentioned last quarter.

That is a timing effect, and simply the flip side of the softer contract manufacturing number we showed you in Q2. On profitability, year-to-date group EBITDA improved to -7 from -10 million SEK last year, and our ex-US EBITDA remains positive year-to-date with around 3 million SEK.

In the quarter itself, group EBITDA was -7 million SEK compared to -6 last year, but that comparison is influenced by some one-time effects, the biggest one being a one-time adjustment that lowered our selling expense in Q3 last year. If we adjust for those, our underlying EBITDA in the quarter was actually improved.

Cash burn, as I said, came down significantly. Cash flow was around 14 million SEK in Q3, compared to around 30 in Q2.

The second quarter was, as the final intensive period towards our NDA submission, and responding to the FDA's questions during review, what we're doing now, has so far required considerably less cash. We ended the quarter with 40 million SEK in cash on the bank, and on top of that, we have the 50 million credit facility with a local bank that we put in place in July, which we have not drawn on.

Then, of course, on the US, the big one. In August, the FDA accepted our NDA for review.

That confirms that our application is sufficiently complete for a substantive review, and the FDA has set the PDUFA date, so that is the target date by which the agency will complete its review and take a decision, on April 16th next year. Now review is underway.

Every FDA review involves some uncertainties, and approval is not a given. Far, we've had a constructive dialogue with the agency, and we are responding to their questions as the review progresses.

In parallel, our FDA-authorized early access program is underway, with a few US hospitals already treating patients today. If we then move to the next page, slide four, please, you see the same picture we've shown you before of our multi-year turnaround efforts, now updated with the first nine months of 2026.

Just to recap, coming out of COVID, we made it a big priority to reach profitability outside the US before launching there. We ran a disciplined turnaround program, cutting significantly into everything that is non-customer-facing.

Our Swedish headquarter today runs with less than half of the people it used to, while we then reinvested part of that freed-up cash into the front line. We've become a much more customer-centric, commercially execution-driven company, and have a much more disciplined and differentiated in how we invest across our markets, doubling down where we see profitable growth momentum, and also pulling back where we don't.

We also acquired our main supplier in Malaysia, which has reduced the cost of goods of our main device quite a bit. You can see the results of all of this on this slide.

Sales have grown from 123 million in 2022 to above 200 last year, and now we stand at 147 after nine months. At the same time, group EBITDA has improved from -68% in 2022 to -5%, and ex-US from -65% to positive territory.

Keep in mind that the year-to-date number, the '26 number, include our seasonally weaker quarters, Q2 and Q3, but not yet the fourth quarter, which is typically our strongest, or one of our two strongest ones. A consistent multi-year improvement in the bottom line that has also outpaced the sales growth, meaning we keep doing more with less.

If we then turn to page five, let's talk about Germany, where we have seen a significant improvement in the performance, even though we're not fully there yet where we want to be. After a decline of 18% in local currency in the first half of the year, Q3 came in at -2%, very close to last year's levels.

Year-to-date, we're still down 14% in local currencies, which is, of course, not where we want to be, but the trend is clearly moving in the right direction now. There are two things behind that improvement, and I think it's important to be clear about both.

First, the market headwinds have eased a bit. Robert Koch Institute data show that ICU admissions with severe acute respiratory infections were significantly lower than last year in the first half.

In the third quarter, they were still lower than last year, but at least came closer to last year's levels, a little less headwinds there. Second, and this is what we can control, the acceleration program we've put in place under our new sales leadership earlier this year.

The majority of German ICU hospitals are already our customers, representing more than two-thirds of the addressable market, our biggest opportunity is really to deepen penetration within existing high-potential accounts. There we've done a lot of work.

Every key account manager now has clarity on the high-priority accounts in their territory. Activities have shifted markedly, with the majority of customer interactions now directed at prioritized top accounts.

Looking at our priority accounts in isolation, sales to these high-potential accounts have actually already shown robust growth in Q3. They've already performed better than the national average, and I take that as an evidence that the approach is working, and we will successfully return to growth.

Still early days, and we have more work ahead of us to bring Germany back to growth, but the direction is definitely right. We then go to page six.

This puts it into a slightly longer-term perspective. What you see here is our order intake in Germany, that's the blue line, and the ICU admissions with severe acute respiratory infections from the Robert Koch Institute in purple.

Both are indexed to January 2024, we can have a good comparison. It's also shown as a trailing 12 months, we take out some of the noise in the data that comes with the high volatility during the year.

Every data point here in this graph represents the last 12 months. Now you can have three observations here.

First, our sales in Germany have directionally followed the ICU caseload, and that's not surprising. Respiratory patients represent a big share of your typical ICU population, and when there are fewer patients in the ICUs, then customers reorder later and in smaller volumes.

That's what we've seen for as long as we've had lower patient volumes. Second observation is that the sales lag a little bit behind the ICU caseload, so that also makes sense.

As you can see, the peak in our sales comes a bit later mid-last year than the ICU patient numbers have peaked. Thirdly, since the peak in mid-2025, the ICU caseload has declined more than our order intake or our revenue have declined.

We've held up a bit better than the market, and that is exactly where our acceleration program is aiming: so to decouple even more from the market trend by increasing penetration in our high-potential accounts, so that our growth is driven by our own execution rather than by the respiratory season. Next page, please, page seven.

This is our other direct markets, mostly Spain, France, and the UK. These markets grew 11% at constant exchange rates in the quarter, 19% year-to-date.

In Spain, we continue to grow at a little bit of a softer level than the prior quarters. This is seasonally our weakest quarter.

During summer, many ICUs in Spain reduce their capacity, they operate at reduced capacity with fewer patients, and you also have a bit of a hierarchy in who gets to take the summer off. In the summer months, you see a lot of more senior staff on vacation, and ICUs are sometimes run by more junior doctors and nurses that are sometimes a bit less familiar with our therapy.

We've seen a little bit of that effect during the quarter. Year-to-date, Spain is still going strong.

Strategically, our focus in Spain remains the same, we're trying to establish inhaled sedation with isoflurane as a standard in as many hospitals as possible, and driving penetration specifically in neurological units following the positive Sedaconda study. France was the fastest growing market in the quarter, driven again by the continued uptake in the AP-HP network, those are 38 university hospitals in and around Paris, where our Sedaconda isoflurane had been blocked until earlier this year.

We've made some good progress also in other high-potential accounts, for example, in the Lyon area. We also had the listing of our drug renewed in the tender with UniHA, that is the largest French public hospital purchasing group.

A series of good news here, and also the restructuring that we've been going through is nearing completion, with a new country manager that will start now in just two weeks in November. In the UK, sales are up, but only modestly in the quarter.

Penetration is still lower than in other countries, and we still see a lot of growth potential. We are changing our geographical footprint a bit to bring our key account managers' location better in line with the growth opportunities, and going forward will have a stronger presence in London and the Southeast where many of the high-potential hospitals are concentrated.

Page eight shows our distributor markets, which continued their solid growth trajectory, growing 27% at constant exchange rates this quarter, 23% year-to-date. Once again, growth was driven by positive development in both South America and the Kingdom of Saudi Arabia.

This builds on the groundwork we laid last year, providing very targeted support to prioritized partners, and at the same time, also terminating several distributors that weren't contributing as meaningfully. Then let's switch gears on page nine and look at the US.

As this is our largest growth opportunity. Comparing it with our current direct markets makes that very clear.

In the US, more than 2 million adult ICU patients are mechanically ventilated each year, and we estimate the US market potential for our products to at least $1 billion, or 10 to 12 billion SEK as you see it here, roughly three times the potential in our current direct markets. The day we receive US approval, our addressable market would essentially quadruple, which is very, very exciting.

That higher potential comes from a larger number of ventilator beds, a medical practice that favors intubation and mechanical ventilation more than we have it here in Europe, and also a generally higher price level, although we haven't built in any price premium into that estimate yet, there could be additional upside there. Just to illustrate, if we were to reach a penetration level close to where we are in Germany today, we would be looking at sales of around 1.5 billion SEK in the US, which would change the trajectory of the company completely.

Page 10, just a brief reminder of our launch strategy. We continue to believe we will create the most value by launching in the US ourselves through our own commercial subsidiary.

That way we keep control of our asset and can capture more of the upside, and by achieving proof of concept in the US, we increase the value of the company further. At the same time, we keep the option open to add complementary partnerships at a later stage if we were to create even more value that way.

That approach, we believe, works despite the market size in the US, because the US is fairly concentrated: less than 5,000 hospitals with ICU care, roughly 2,800 with more than 10 beds, which for US standards is still very, very small units. We can pursue a very targeted launch built around a network of key opinion leaders and the roughly 30 clinical trial sites we've already established, which are very supportive of the therapy.

During the review period, we are also working on launch preparations already. We've just completed our pricing research, and further fine-tuning our go-to-market model.

Of course, all of that depends on approval. Let's look at where we stand in the FDA review on the next page, page 11.

That shows where we stand. Right now, the foundation, as is our two successful pivotal Phase 3 trials, INSPiRE-ICU 1 and 2.

Both met their primary endpoint of non-inferiority to propofol with no new safety findings, and we expect meaningful differentiation from the secondary endpoints and PK data, which Peter will go through just in a moment. On the regulatory side, we have fast-track designation, and early access program is underway, and we continue to see good interest there.

Then we submitted the NDA in June, which in August got accepted for review by the FDA, and we now have a PDUFA date that we're working against, which is in April 2027. Now we are in what's called the substantive review phase, responding to the FDA's questions, and we're also preparing for the inspections that are part of any review, building on the mock audits we've already done with former FDA inspectors.

As I said earlier, every FDA review has some uncertainties, but so far, I have to say the dialogue has been really good and constructive. On the right side, you see why we believe our therapy would fit very well into the US market if we get approved.

First, the reimbursement mechanism: under the DRG system, hospitals receive a fixed payment per hospital stay, they benefit financially if patients come off the ventilator earlier and leave the ICU faster. An ICU day in the US can cost up to $11,000.

Second, there's much higher awareness of the opioid risks in the US because of the opioid epidemic, opioid-sparing therapies, therapies reducing the need for opioids, are seen as a clear positive. Third, it fits really well with existing treatment recommendations already, such as the CDC's Wake Up and Breathe Collaborative, which aims to get patients again off the ventilator sooner and speed up recovery.

With that, let me hand over to Peter, who will take you through our clinical data and the medical activities we have underway in the US.

Thank you, Johannes. As Johannes mentioned, we met the primary endpoint in our clinical studies in the US, non-inferiority compared to propofol.

We also had a greater opioid reduction in both trials, similar to our European Sedaconda study. This is of significant when it comes to clinical practice and appeal of this therapy.

Opioids cause a lot of short-term and long-term issues in ICU patients, including constipation, which almost all patients receive treatment for, respiratory depression, which can delay spontaneous breathing tests, play extubation, and opioids are also associated with withdrawal and delirium, delirium is dose-related. There are also indications that opioid doses during mechanical ventilation are associated with a higher risk of persistent opioid use in the year after ICU discharge.

This is, of course, very favorable to have a therapy that's opioid-sparing. Faster return to wakefulness was found in our studies, similar to all the studies that have looked at this endpoint when it comes to isoflurane.

This is related to the pharmacokinetics of isoflurane. Elimination is completely independent of renal and hepatic function, and means that all patients will eliminate drug within minutes to an hour, similar to the operating room.

This means, in turn, that patients can be assessed neurologically with greater certainty, and reduce the number of CT scans. Wake-up time is short when you want to extubate a patient, which also is a clinical benefit.

We believe that this can be leveraged once this is approved in the US. Also, in the trials, we've found a numerically lower mortality with isoflurane compared to propofol, which, of course, is maybe one of the most important safety endpoints in a clinical trial, particularly ICU patients.

Moreover, we did find one more ICU-free day across our trials, which could translate into substantial cost saving. As mentioned, the elimination of isoflurane is almost exclusively via the lungs, with minimal metabolism.

That means that patients with organ dysfunctions, which are very common in ICU patients, will eliminate this drug in a reliable manner. This all fits very well together.

If we move to the next slide, please. As many of you may know, the trials, the INSPiRE-ICU 1 and 2, took place in 31 academic sites across the US, matching fairly well the population density in the US.

Many of these sites are very interested to see this approved and to start treatment with this on a daily basis. We move to the next slide.

Some of these sites have also engaged in the early access program. The early access program is an FDA pathway to make investigational medical products available for vulnerable patient groups before full market approval.

In our case, this relates to the difficult-to-sedate patient population that cannot be managed well with IV sedatives, or who are experiencing side effects from those drugs. The EAP is open for all hospitals who wish to initiate it, but of course, it's also with a startup phase with contracting, investigational IRB approval, and so on.

The benefits of the EAP is, of course, primarily for the patients and for caregivers. For us as a company, it's also valuable because this means that we are able to continue gaining experience of inhaled sedation in the US.

Some of our study sites also are able to keep up their practice with this therapy and become more proficient. We can also develop everything from supply chain to training and implementation.

We have 10 hospitals that have expressed interest and are still interested. We have three up and running, and three additional sites initiating in Q4.

Then we have a few early 2027. Move to the next slide, please.

When it comes to our medical affairs activities in the US, preparing for launch, we have a few different activities. We had an advisory board in August 2026 with a mix of healthcare professionals, experts in the field of mechanical ventilation, sedation, and also pharmacy.

We discussed, among others, different patient categories, and outside INSPiRE-ICU patient population, which is a broad mix of general ICU patients. There was also significant interest in ECMO patients and neurocritical care patients.

These are patient groups that often require deep sedation, often require wake-ups, are very difficult to transport for a CT scan, for example. A reliable, safe drug that is rapidly eliminated, allows for neuro examinations, is a perfect fit for these patient groups.

There are a number of clinical trials in Europe on these patients, and they're also mentioned in different sedation guidelines, including the Spanish guidelines. These are patient groups that we believe we will be able to target outside our study population.

We also discussed workflow integration in the US ICU setting, which is slightly different from the European one. A few topics that were discussed were gas monitoring and humidification, how to streamline and make our therapy as easy as possible to integrate.

Then we have had discussions also on having a hub-and-spoke principal center of excellence that would support implementation broader across other ICUs with less experience. We have a clinical pharmacist ad board upcoming now in November.

Pharmacists are key persons in the ICU when it comes to implementing new therapies, including sedation. They are a small group of people who stay in the ICU, which is slightly different from many of the doctors that come for shorter rotations.

Their endorsement and their education is very important when implementing a therapy like ours. At the ad board, we'll be discussing everything from P&T committee support, how to manage sedatives and sedatives stewardship in the ICU and how pharmacists play a role there, how we can support ICU pharmacists when we launch, and also other considerations related to institutional implementation.

Besides the ad boards, we're also having scientific exchange with our trial sites, and EAP network meetings with those that are up and running, and the other sites that are very soon going to be starting. We will start a series of disease awareness webinars targeting healthcare providers in the US and discussing pain, agitation, delirium management more broadly.

We have a number of top key opinion leaders that will be helping us drive these webinars. Finally, we are working on the publication of the INSPiRE-ICU trials.

We hope to see a publication by the end of this year. We also doing additional analysis of study data, post hoc analysis, that we believe will provide interesting and valuable data at the time of launch.

Next slide, please. Finally, just to discuss a little bit about a recent study that was published in JAMA, the SAVE-ICU trial.

It's related to last year's sevoflurane study, the SESAR study. That study was on ARDS.

SAVE-ICU study is an investigator-initiated study without Sedana's involvement, driven by investigators from Toronto, and almost all sites were in Canada, one was in the US. It's the largest study to date on isoflurane-based sedation versus IV sedation.

The target population in this trial were patients with acute hypoxic respiratory failure, which is the gas exchange equivalent of ARDS, without a radiological validation of ARDS. These patients were sedated for an average of six days, and the primary endpoint in the trial was mortality, in-hospital mortality.

The results showed 42.5% hospital mortality for isoflurane versus 43.8% for IV, just 1% lower mortality with isoflurane. At three months, the difference was 3.4% in favor of isoflurane.

None of these results were statistically significant, but that's to say that this is an important counterweight to the SESAR study, and contrasts in that patients in this study survived more in the iso group than in the IV group. That was different in the SESAR study.

There was no sign of any renal injury from isoflurane either, and this is consistent with what we've seen in our trials, and what's been published previously. There is a clear difference between sevoflurane and isoflurane, and I think this study very well demonstrates that.

In waiting for our main publication, we're also doing to publish on the INSPiRE trials, we've been looking at pooled data from the INSPiRE studies, and in that cohort of patients in those two studies, 27% of all patients had acute hypoxic respiratory failure. Sorry, all 27% of all patients in the studies had AHRF.

So 75 patients receiving isoflurane, and 50 receiving propofol. Looking at the 30-day mortality in those two groups, it was 21.8% for isoflurane, and 28% for propofol.

A little bit more than 6% difference in mortality. This difference is not statistically significant, but it's still very reassuring if we think back of the study last year on sevoflurane.

This, both our own data that's on file and the SAVE-ICU study, indicate clearly that isoflurane is not something that one needs to worry about when it comes to acute hypoxic respiratory failure. Then we move over to the next slide, and I think it's time for me to hand over to you, Mikael.

Yes.

Thank you. Turning to our financial results, net sales in the third quarter reached 44.2 million SEK, representing a growth of 7% year-on-year.

Johannes has been through this, but reiterating, we're back to growth with stronger performance in Germany, although not growing yet. Other direct markets grew 12% reported, distributor markets grew 26% year-on-year, and contract manufacturing was up 48%.

Gross profit, 30.8 million SEK, up from 29.5. Gross margin, 70%, 72% last year.

There's some diluted effect from higher share of contract manufacturing, and there's also a one-time reclassification effect in last year improving the gross margin. Essentially, the gross margin remains stable at slightly above 70%.

EBITDA, -7 million SEK versus 5.6 last year. Ex-US EBITDA, 3.2, -3.2 versus last year's -1.7.

If you look at OpEx numbers for this quarter, we're at 45 million SEK versus 40 million SEK last year. Essentially, it's quite flat.

So 1 million of that is FX-related. 2 million is related to increase of depreciation that is reported under OpEx externally.

There were some nonrecurring items both in Q3 this year and last year affecting comparison. If we net those out, it's fairly flat development on OpEx.

While we're doing this, we're investing resources in the sales organization, shifting resources to frontline. Talk about resources, staff, including consultant, were 129, including everyone.

If you look at excluding, in particular, Circon, meaning our sort of daughter company in Malaysia, we were at 81 staff, including consultants, at the end of Q3 this year, compared to 83 end of Q3 last year. Moving to cash flow and liquidity, we ended the third quarter with a cash position of 40 million SEK, compared to 52 million at the beginning of the quarter.

Cash flow from operations were negative 3 million, negative EBITDA contributed with 7. We had positive contribution from working capital of 4.1, and there was a few other items.

Essentially, that was that. Cash flow from investing activities were negative 9 million.

That's down from the same quarter last year, it's also down from same quarter or previous quarters of Q2. We're at the lowest level that we show on the right-hand side.

You see the light blue bar is the investing activities, it's declining. That's an effect of that we've submitted our NDA, and we're now in a different period, we're in the review period, which consumes less cash.

The total cash flow was -14 million, compared to -17 Q3 last year. Onto that, you need to add a currency effect of 1.6.

That brings the cash change from 52 to 40 for this quarter. In addition, we have a credit facility that we talked about last quarter of 50 million SEK.

The available funds stand at 92 million SEK. We're well-funded to take us through the review period and the approval in the US.

Thank you. That was the final slide in this, or are we handing back to--

Yes, there's one one last slide, page 12, just to sum everything up. This is showing our value creation plan built on our three three pillars.

Number one, further profitable growth in Europe. As we've seen, our ex-US business is EBITDA-positive year-to-date, even after our seasonally weaker quarters, Q2 and Q3.

We are back to growth in this quarter. There's significant remaining potential in our core markets.

In Germany, our best territories already have considerably higher penetration levels than the national average, and also in our other direct markets, penetration still offers a lot of upside, there's a lot more to go for. Number two, a successful launch in the US, our largest potential market, three times the size of our current direct markets.

With the NDA under review and PDUFA date in April, we are closer than ever, and if we get approval, we can build on a strong product-market fit and the KOL network we already have in place. Number three, continued cost discipline.

I think we've proven that over the years here. Our business has inherently favorable economics with high gross margins and limited local operating cost requirements.

As we grow, we can leverage that while continuing to secure further gross margin improvements and keeping a tight grip on our operating expenses. Needless to say, the foundation of it all is, of course, a therapy that makes a real difference for critically ill patients.

Every ICU patient has a life that is worth getting back to, and no one should be in the ICU longer than absolutely necessary. That's what we're really working for every day.

Helping them wake up faster, recover faster, and leave the ICU a bit sooner. Thank you very much.

This concludes the presentation, and we will now open it up for Q&A.

The observation is not wrong. Q3 is oftentimes lower than Q2, so that's maybe in itself not so unusual.

What is true is that Spain is the main driver behind the growth in other direct markets being a bit slower this time. Having said that, though, Q2 was quite strong, with 41% growth in the other direct markets, and Q1 was on the softer side again, 7%.

It's not completely unusual to see a little bit of up and down. The 11% is on the lower end.

Last year, we had 30% for the full or 32% growth in those markets. I expect that the growth will continue at a robust rate, including Spain.

At some point, Spain, of course, comes to a point, just from a mathematics perspective, I think Spain has quintupled since 2022. In percentage terms, the growth will decrease a little bit.

At the same time, we have France that is finally really performing well, and shows in percentage terms very high growth. As that is gaining scale, then that will help the overall growth in those markets as well.

The same goes for the UK, once our restructuring is complete with the geographical reshuffling, and we focus our energy on the right accounts. I'm expecting that to take a similar trajectory as France already does.

In short, yes, maybe a little on the soft side, but we've had soft quarters before that were then followed by very strong quarters, no reason to be concerned.

As I've also shown in one of those slides, there is a certain dependency on flu seasons and ICU caseload and so forth. The way I understand the question, if we take that away and have a more neutral development of the market, then what would the performance look like?

I think we are in the middle of a turnaround here. I've described all the things that we are doing different: so much, much sharper focus on under-penetrated high-potential accounts, much more targeted sales training, much more rigorous follow-up, and analytics-based targeting.

We're seeing the first results of that. The accounts that we have in focus, which, by the way, represent a quite sizable part of our German business, if we look at those in the quarter, they actually showed very good growth already.

Now, we're not there yet on a national level. It was still a small gap versus last year.

What I want to see is a return to growth, because we are not yet fully penetrated in Germany. We've not yet hit the ceiling, and I can say that with some confidence, because I see it in the field.

There's hospitals that are using this as a standard therapy, and there's others where that is not yet the case. There is a lot of unused potential to go for us.

There's always going to be a little bit of noise with external market factors, but we stay focused on what we can control, and that's execution. That makes me quite optimistic at this point.

Thank you very much for taking the time. If there's more questions, you know where to find us.

Then I wish everyone a continued nice afternoon.