Bavarian Nordic A S

Welcome everyone to today's presentation, which is an update on our results for last year, 2025. Today you'll hear from me, a few slides from myself, and then I'll hand over to Henrik Juul, the CFO. So if you turn to slide four, we reported very strong results last year, 6.2 billion in revenue with a 28% EBITDA margin. And this is the result of very strong performance of both arms of our commercial business on travel health, but also on public preparedness. On travel health, we saw a 30% growth last year, which is a very strong performance across the whole portfolio, but also related to the launch of our chikungunya vaccine. On public preparedness, In 25, we were at the back end of an outbreak of MPOCs, and we saw more than 3.1 billion in revenues, which is approximately a billion kroner above the upper end of our normal base business. So as I said, very strong performance from both parts of our commercial business in 25. In addition, we sold a product review voucher valued at 810 million kroner. And if we included this in the EBITDA, this would bring the EBITDA to a 41% margin. Some events that have happened since in this year, which are noteworthy, is we've announced two agreements, one with Europharma for the distribution of our chikungunya vaccine in Brazil. And earlier this week, we announced an extension or an expansion of our strategic partnership with the Institute of India to produce our chikungunya vaccine. And both of these are related to improving the access of vincunya in those regions. Today we also announced the second trance of our share buyback and I'm sure Henrik we're coming back to more of that in the future slides. And last week we announced that after a long tenure at Bavaria Nordic. Unfortunately, I think it's 27 years. I have decided for different reasons to step down later this year, but I've agreed with the board that I'll be staying until the end of the year or until a replacement has been found. The outlook for 26, Henrik will go into much more detail, but here we're guiding for total revenue of five to 5.2 billion with an EBITDA margin of 25%. This is made up of another strong year of growth for travel health of 3 billion and public preparedness of 1.8 to 2 billion, reflecting coming out of the public health crisis for MPOCs and reflecting a more normalized year for public preparedness. We turn to the next slide. Talk a little bit more about the travel health. As I said, last year we saw a 30% growth. This is primarily due to rabies and TB vaccines where we saw a 34 and a 20% growth respectively during the year. We see an outstanding performance of rabies and I'll come to some of the reasons for that in the next slide. But in the US, we saw a double-digit growth and an improvement in the market share up to 78%. In Germany, we saw a remarkable growth of 48% in the market, but also a 6% improvement in the market share to 97%. So strong performance in both of the two key markets for rabies. Similarly for TBE, we saw 20% growth and an improvement in the market share in Germany from 28 to 31%. So really a very strong performance, brand performance for both products, but also a strong market growth in both areas. And moving forward, we still stand by the projection of a 10 to 12% annual growth in travel health, but of course, starting from a much higher standpoint than we had originally reported at the Capital Markets Day. To go to the next slide, why are we seeing such strong growth in rabies? Well, in Europe, we've seen cases, fatal cases, unfortunately, of travelers returning from North Africa to the UK, France and Spain. And these have obviously hit the media and raised the profile of the dangers of rabies. In the US, we're seeing the CDC are tracking what looks like 15 likely outbreaks of rabies in 12 different regions of the US. And last year, we saw an increase in the number of deaths in the US, which is six deaths up until September of last year. So these outbreaks the unfortunate deaths, which are higher than typically seen, has really raised the profile of the importance of, or the dangers of rabies, both in the US but also in Europe, and this is one of the underlining reasons we're seeing a very strong growth in the market, and obviously we are the market leader benefiting most from this increase. So if you turn to slide seven, Last year, we saw the first approvals of vincunia, a vaccine against chikungunya, both in the US and in Europe. And that led to an outstanding launch performance in 25. We had launched in the US, I think, within four weeks of the approval, which is, I would say, a gold standard performance within the industry. And we launched in, I think, almost 14 countries by the end of the year. We exceeded the guidance in terms of revenues for the guidance of 75 million kroner. And in terms of volume, we saw a very successful launch, which is associated in terms of volume greater than some of the recent vaccine launches for travel vaccines. So very happy with the performance in 25. It is setting ourselves up for continued growth in 26, where we are guiding for 250 million kroner, which is a significant growth. We are seeing very strong demand in the markets that we've launched. And Vinconia, our Chikungunya vaccine, will be a key driver of future growth within the travel health franchise in the coming years. We turn to the next slide, slide eight. In public preparedness, as I said, in 25, we were coming from on the back end of the public health emergency that was declared by WHO and Africa's CDC for the outbreak of MPOCs in Africa. And we saw stronger demand or as we've often referred to it as spike demand over our base business, seeing more than 3.1 billion in revenues June 25. What we are anticipating in terms of 26 is a more normalized year guiding for 1.8 to 2 billion krona. And of that, we've already secured 1.4 billion krona of that revenue to various different contracts that we have in hand. So again, a very strong year is planned for 26. In addition to our activities, we also have a number of ongoing clinical studies which are supported in part by CEPI, both in children, in infants, and also in pregnant women. And hopefully these studies will enable the expansion of the label, which already includes adolescents and adults in certain territories, to also include infants and children. which essentially will hopefully lead to an expansion of the label for the entire population. We move to the next slide. So on public preparedness, we often refer to our base business of being 1.5 to 2 billion kroner, but we anticipate there will be spikes in that base business from time to time, either associated with outbreaks of MPOCs, or as we've seen historically, one-off larger orders from governments. And on slide nine, what we're showing you here is a map of the recent cases of MPOCs. And what we've seen is a 67% increase in the cases of MPOCs reported already in 26 in Europe. And if you just look at Spain, There are 53 cases in Spain since January 24, but almost 50% of that is in 26. And in France, similarly, 10 cases since 24, but six of those are already within this year. And this indicates that MPOX has not gone away. While it may not be part of the news flow for good reasons, There are still cases, and there does seem to be an uptake in the number of cases already this year. And of course, we are really the only supplier of an effective safe Mpox vaccine globally. If we go to the next slide, in terms of pipeline, we have a number of different trials ongoing for our chikungunya vaccine. These are trials related to commitments that we made to the regulators as part of the approval. So we have an efficacy study ongoing and a study in children. The pediatric study will hopefully lead to a broadening of the indication. We also have a study for MDA, our smallpox and mpox vaccine, where we are moving to making a change in our manufacturing away from eggs into a proprietary cell line. This is a phase two study that was initiated last year and will be completed or the top line data will be reported later this year. We have an ongoing phase two study for equine encephalitis, which is a vaccine fully funded by DOD. And we have preclinical assets, both for Lyme disease and Epstein-Barr virus, which for priority reasons, we now plan to move into the clinic next year. So a lot of ongoing activities in terms of the pipeline, many of which are associated with life cycle changes or supporting the commercial assets. And with that, I will hand over the presentation to Henrik Juul. Thank you very much, Paul.

So let's start with an overview of the commercial performance for the fourth quarter of 25 and full year 25. So we had a very strong finish of the year. with revenue, total revenue of close to 1.5 billion Danish kroner, comprised of nearly 800 million on public preparedness and more than 600 million from our travel health business. So worth noting here is really in particularly the travel health business within the fourth quarter last year delivered 61% growth. So looking at the full year, let's finish on public preparedness first, we deliver 3.1 billion Danish kroner, exactly what we had guided for in November when we refined our guidance to 3.1 billion. From that business, as Paul explained earlier, this is more than a billion about the upper end of our normal base business within public preparedness. Travel health ended close to 3 billion Danish kroner, 30% up on a full year basis compared to 24. and driven by very strong performance by Rabipur, RabiVert and Insipur. And Paul already talked about the reasons behind that, basically driven by both strong market growth, but also very strong brand performance for both products. So nearly 3 billion Danish kroner on travel health, which was above our latest guidance provided in November, where we said 2,850,000,000. So driven by this very strong finish of the year. it's also worth while mentioning vimkunia here we delivered 85 million Danish kroner and revenue for the full year against our latest guidance of 75 million so again somewhat about the latest guidance and a very good start in a launch year so 6.2 billion and 44 million Danish kroner total revenue for the full of So let's turn to the next page and look at the full P&L, again for the fourth quarter and full year of 2025. So if we focus on the full year basis, the 9% growth and the 6.2 billion in revenue we just talked about, production costs of nearly 3.2 billion, leaving us with a gross margin of 49%, somewhat lower than what we saw for the first nine months. driven by the low gross margin we saw in the fourth quarter, where we delivered 39%, and which I think demands a little explanation here. So what we did during the months of December, or Q4, we made a provision on our tick-borne encephalitis product, Insipur, based on the current discussions with the regulators. We got, on our own manufactured version of the vaccine, we were 12 months shelf life with the product we acquired from GSK and that was produced by GSK. We have the 36 months shelf life and of course we have an anticipation that we can increase this shelf life. We just need to provide the necessary documentation and data points to the authorities. So we've made a provision and assuming that we could get the shelf life up to 18 months from the current 12 months. And based on that, you can do a simple calculation to see, okay, some of these vaccines, if we stay within 18 months, we will simply not be able to sell before they run out of shelf life. So a significant provision was made from that in Q4, but we managed to contain it within our current guidance due to the generally very good performance within our manufacturing area for the full year of 2025. And I would say that if we manage to agree on a longer shelf life than 18 months, then obviously in 25, sorry, this year in 26, we will have an upside when we reverse the provisions. On the other hand, if we do not get to 18%, but end with something lower, there's a small downside. We find the downside very unlikely, and it's more likely that we will have an upside during 26 as we anticipate to agree with the regulators to get a longer shelf life approved. So 49% is where we ended the full year on gross margin. R&D cost ended at 780 million Danish kroner. Originally, when we guided 425 back in February last year, we said we anticipated to spend approximately 900 million Danish kroner, but we also late in last year alluded to there might be upsides that we could make some savings for different reasons, one of them being that we are waiting this efficacy trial on Vinconia to be run in an outbreak session, and that outbreak has not happened yet. So 780 million, so we spent less than what we had originally guided. SG&A had 1,275,000,000 Danish kroner spent last year. So quite a significant increase, over 24, driven by deliberate decisions. First of all, to put money behind the launch of Lincolnia, but also to expand our network of sales entities in the process of taking the business back from our partner in Europe, Vannevar. And then we also made a decision to expand our sales force in Germany to take advantage the market growth on tick-borne encephalitis. So with total operating cost of 2,055,000,000, we get to an EBIT of 1.8 billion. And that is when we include the income from the voucher. That's the 810 million Danish kroner net income from the sale of the priority review voucher. And then if we convert to EBITDA, which is the measure that we guide on, you will see at the bottom there, 2.5 billion Danish kroner in EBITDA. And if we exclude the voucher, we're talking about 1.7 billion in EBITDA. So very strong financial performance last year. And if we just quickly compare to our latest guidance, we said that we would land approximately at 6 billion Danish kroner. We are delivering more than 6.2. So delivering better than guided on top line. And on the EBITDA margin before the voucher, we got 26% and delivered 28%. And the difference here is really driven by the lower spend on R&D, but also on the very strong finish of the year delivering additional revenue. So very strong performance. And I think if we compare to the original guidance provided in February of last year, ending exactly in the midpoint of that guidance both on revenue but also on the EBITDA margin. If we then turn to the next slide quickly on our cash flow and on our balance sheet here, the strong cash flow obviously driven by the profit from the business and again with a good contribution from the sale of the priority review voucher, investments, activities, negatively impacted by the milestones we paid back to both the emergent buyer solutions, but also GSK from the acquisitions we did previously. Here we spent 1.1 billion Danish kroner, and the rest of the impact on investment activities really comes from placement of our cash into securities. Cash flow from financing activities was negative 114 million. And that was impacted by the first strands of the share buyback we did of 150 million Danish kroner, partly offset by a proceeds from a warned exercise that happened last year. On the right side of this slide here, you see a selected balance sheet items. And I will just here point to the all current cash balance. So cash and cash equivalents of 3.3 billion. By the end of December last year, at that time, we had not paid the last milestone to GSK, but that has happened here during Q1. So that means if everything else is equal after that payment, we have approximately $2.8 billion of cash available. We have also this morning announced the second tranche of our share buyback, this time $200 million that we anticipate to complete within the next one to two months. So again, strong financial position with a good cash position and obviously no debt at the moment. Let's turn to the last slide, elaborating on our outlook for 26. This outlook is unchanged compared to when we announced our preliminary 25 numbers and our outlook as well. So we are for this year guiding revenue between 5 and 5.2 billion Danish kroner. and an EBITDA margin of approximately 25%. So from travel health, we are anticipating approximately 3 billion. And on the surface, that looks very much like what we delivered in 25. But remember here that from 1st of January this year, we do no longer have the partnership with Geneva, meaning that we are not going to record any sale of the Japanese encephalitis vaccine. We are also getting out of the agreement with Dynavax hepatitis B vaccine, that agreement will end in April. So if you subtract the partner business that is no longer in place, then actually this guidance here corresponds to a 10% growth. And if you look at it in constant exchange rates, we're actually looking at a guidance that corresponds to 14% growth in 26. So a growth rate in our travel health business fully in line with the mid-term financial targets that we set at the capital market state back in 24. On public preparedness, as Paul said, right now, I think 26 looks to be the first normalized year in five years. We've had four years now impacted by various outbreaks, either in Africa, Europe, or U.S., and 26 right now looks to be more of a normalized year. And here we are guiding, I would say, at the upper end of that normalized year, 1.8 to 2 billion Danish kroner in revenue, and 1.4 billion of that has been secured already in contracts. So with that, I will give the word back to the operator and ask for questions. Thank you.

Thank you. If you would like to ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced. And to withdraw your question, you can press star 1 and 1 again. Thank you. We will now take our first question. This is from Romeo Connor from Van Langshot Kempen. Please go ahead.

Hi, all. Thank you so much for the presentation. I have two questions. The first may be more of a clarifying question on the public preparedness outlook. So the base business is now guided for $1.5 to $2 billion until 2027. So I just want to know, especially with the increase in reported cases, can we really expect this normalization to happen, especially what we have seen since, I don't know, 2023. And then the second question is, in the annual report, you mentioned strong focus now on organic growth for the year. I just want to understand your capabilities for M&A for the next few months and what your current bandwidth is. Thank you.

Yeah. Hi. Thank you for the questions. So your first question relates to public preparedness. I think in our guidance, which we have 1.8 to 2, it reflects obviously contracts that we've already secured either last year or actually since we've announced the guidance of 1.4. And contracts or opportunities that we are working on that we believe will come through obviously this year. It obviously doesn't include any so-called spike business that we may see if indeed some of the early indications point to that there may be something brewing in Europe or other territories. It does not include anything of that. So this is a more normalized business, although it's at the upper end of our normalized business, but it does not take into account if there is any additional outbreaks of MPOC or if there is a larger order that we're not aware of coming in the next 12 months. The other question related to, I guess, our bandwidth and our appetite maybe on M&A. Our strategy, as you know, is on growth, obviously to grow both parts of the commercial business, our travel health portfolio, but also public preparedness. but it also includes M&A, as we obviously have a very successful track record of acquiring assets and turning them around. I would say that part of the strategy is still very much a focus for the management and the board, and we are searching and looking for assets that we could acquire.

Great, thank you. Thank you. We'll now take our next question. And this is from Thomas Bowers from SEB. Please go ahead.

Yes, thank you very much. A couple of questions here. So first, just in regards to the shelf life related provision you have. So how should we think about the potential impact or tailwind for 26 or is this more potential for 27, given that you may have to take a little bit longer to get to that 36 months of shelf life. And maybe also, can you just remind me, where are you currently with Rappipur on shelf life compared to the former Glaxo-produced material? And then on Vimkunja, so firstly, what is the exact FDA deadline for initiation of the outbreak trial material? in Thailand, and assuming that we don't see any outbreaks, what's the, you could say, the wave, the deadline for the FDA here, and is the study definitely waived by the FDA if no outbreaks happen? And then maybe just quickly also on Vimkunja, maybe the margin focus. So in order to improve margins, so of course economy scale here is important, but is there anything in the current setup also with the contract thin finish that you're using that Vimkunja sort of in the mid to or near to mid-term will actually be starting to become accretive for your current EBITDA margin level, or do you need to make decisions, for example, with the fill finish in order to improve margins significantly above the current level? Thank you.

Thanks, Thomas. Let me take a stab at these answers, and Henrik, please, you can jump in if I... Don't address it all. So your first question was on the shelf life. So let me take a step back. So in the tech transfer for Entepor, obviously we had to transfer both the drug substance, the bulk manufacturing, but also the full finish. And in that plan, we knew that by the time we filed with the authorities, we would have limited shelf life. And obviously everything to do with the tech transfer is demonstrating comparability between to the product that you're transferring from, so to the GSK material. So when we discussed with the authorities late last year, we had limited stability data of the products that we had manufactured at the end. And that led to this limited shelf life recommendation. But obviously, since then, and every month, we get more and more data, more batches being manufactured. And we anticipate that that shelf life will be extended as and when we get more data. Now that doesn't mean to get the three year shelf life, we need three year data, but because you can do projections, but to do projections, you need more robust number of data points. So we anticipate on the positive side that we will see shelf life extensions during this year, and maybe we'll be back to the 36 months maybe in early next year, but that all depends on data. In terms of, you also asked on RaviPort, there we have the same shelf life for the BN material as the GSK material. And that just relates to how much data we had at the time when we filed. So I hope that answers those questions. Yeah, great. Then on Chikungunya, you asked about the efficacy trial This is a trial design that was agreed with the regulators as part of the approval process. And here we have to enroll a number of subjects in a region that may have an outbreak. So it's a design where we enroll subjects in the anticipation that there will be an outbreak in that region. If there is no outbreak in that region, once we've enrolled all the subjects and collected the data, will end up with no efficacy data. That's just the way the trial is designed. And in that case, we would then have to open the dialogue again with the regulators on what is then the requirements with the regulators. And some of that discussion is already ongoing, whether that's an additional efficacy study or an effectiveness study, there are different possibilities and dialogues that we're having with the regulators. Then the other question related to margin improvements on Vinconia. You're right. A big part of how we'll improve the margin on Vinconia is related to volume. And obviously when you launch a product and you're in this phase where you're raising awareness and all the rest of it, of course, it is an expensive vaccine to produce. So volume will cause a reduction in the margin in the years to come. In addition to that, we are making improvements to the process. We've already made improvements to the process, which was filed with the regulators, which we're hoping for approvals of later this year, within the first half of this year. And we continue to look at making further improvements also in both the bulk manufacturing, but also the drug product manufacturing. And they will have margin improvements in the years to come. So, Henrik, do you want to add anything?

No, I think that was a good summary, and I think it's continuous work on improving the cogs on vincunia. And it's quite normal that you start with a quite immature manufacturing process that more or less comes directly out of the laboratories, and then you start working on process improvements. And as the filling part is done with EMO, it's quite expensive in low volume. we will drive better markets on the Konya through process improvements and volume benefits.

That's great. Thank you very much.

Thank you. As a reminder, if you would like to ask a question, please press star 1 and 1 on your keypad and wait for your name to be announced. And to withdraw your question, please press star 1 and 1 again. That's star 1 1 for any further questions. We have a question coming through. Please stand by. And a question from Thomas Bowers, SEB. Please go ahead.

Thank you. That was quick for the follow-up. I just wanted to talk a little bit about the governance. So what sort of profiles and competencies are you sort of prioritizing when you are

looking to to expand the border maybe it's not a question for for you but but maybe uh if you can give some color on on on the thoughts here yeah i think you've answered your own question there thomas i think that's a question maybe for the board um there is a process uh ongoing right now to identify some new board members, and I believe the plan is that those successful candidates will be announced as part of the announcement related to the General Assembly.

Okay, then a question that I hope you can answer then. So just in regards to the ACIP recommendation, which you got almost a year ago. So is there any Is there any news on the MMWR publication? And then secondly, just in terms of your prioritization on LIME and EBV, so should we expect a material step-up in R&D spending from 27, given that you have postponed those two into first half, sorry, into 27? And is there a possibility Is there sort of a reason beyond cost saving that you actually are delaying the projects?

Yeah, I can answer these questions. Thank you. On the ACIP recommendation, there really isn't any news on the publication or the status of the MMWR. And therefore... We are continuing to talk to various different distributors on how to move forward. I think there is a recognition that the world is changing and that we can't simply just wait around for the MMWR. As you know, some suppliers really want to see that publication before they will start buying the vaccine. I think we're seeing movement now that people are recognizing that this may take longer than normal. So we have no real news on where that will be in terms of the publication. In terms of the pipeline assets, you're right. There's a balance here in prioritization and ensuring that we're delivering the EBITDA margins that we have stood by, the minimum 25%. We obviously right now have an an R&D budget that is securing the activities, the regulatory requirements for Chikungunya, but also the trial related to moving away from eggs to our proprietary cell line for MVA. As and when those activities come to an end, it will free up funds that we can then focus our activities into other R&D activities, whether that's Lyme, EBV, but we'll look at it. So really what I'm trying to say is we are prioritizing our finances based on the promises that were made to the market in terms of the EBITDA margin, and that will dictate when and how we can move some of the assets into the clinic. I would also say that while we've paused the clinical start of both Lyme and EBV, it does allow us to perform additional preclinical studies in both those areas that may be beneficial when we do decide to move into the clinic.

Yeah, that makes sense. Great, great. Thank you very much again. Thanks.

Thank you. We'll now take the next question. A question from Romeo Connor, Van Lanshot Kempen. Please go ahead.

Hi, while I'm still here, while you can have me, just one final question on Uttam Kunia. So guidance surpassed what we expected for 2025. I just want to maybe get some more color of what we can expect this year. Do we expect the 250 million guidances as purely a base, especially in the light of competitor withdrawals from the markets? Thank you.

Yeah, maybe I can take that one. So, yeah, we are guiding a significant increase from last year where we ended with the 85 and now we're guiding 250. And that is, of course, it's primarily coming from the countries where we already launched, where we expect to see a continued strong momentum and basically market growth where we are the only player, more or less, in most markets. But then we're also anticipating launching in more countries. We are awaiting approval in Switzerland, we are awaiting an approval in Canada, and there are still a couple of countries in Europe where we do not have launched yet. So I think this is, as we see it, a typical launch sales profile when you launch into a market that is non-existing. You will see quite a steep uptake in the beginning, and we are seeing a good demand in the market and 250 I think we believe is doable, but also, of course, a very significant growth that we need to deliver upon.

Thank you. Thank you. And there are no further questions at this time, so I will now hand back to Paul Chaplin for closing remarks. Thank you.

Thanks, everyone, for joining and your interest in all the questions. Have a great day. Thank you.