Bavarian Nordic A S

Welcome everyone to this full year update from Burea Nordic. My name is Rolf Sørensen and today in this conference call we have, as usual, Paul Chaplin, CEO, and Henrik Juul, CFO, to give the presentation and comments to the Q&A session that comes afterwards, as usual. Before we start the presentation, please note that this announcement includes forward-looking statements that involve risks, uncertainties, and other factors. many of which are outside our control and could cause actual results to differ materially from the results discussed. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance, and other information that is not historical information. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law. And with this, I would hand it over to you, Paul, to start the presentation for the full year.

Thanks, Rolf. And welcome, everyone, to our annual accounts for 24. If you go to slide three, so this is obviously we had a very, very successful 24 year. We're reporting very strong numbers. It's the fifth year in a row now we've reported strong, profitable growth. So you can all see the figures on this slide, just over 5.7 billion kroner in revenue, a 28% EBITDA margin, which equates to 1.6 billion kroner. So a very strong year based on strong growth of our travel health vaccine franchise, which grew by 22% compared to the previous year. We're also seeing in public preparedness strong growth due to the current public health crisis on MPOCs, where we've been able to secure contracts for more than 3 million doses, which also will spill over into 25. On the strategic elements for 24, we've been performing very strongly. The tech transfer for the assets that we purchased back in 2020 for rabies and TBE is on track, really, which is impressive and really setting some industry new standards in terms of timelines for complicated tech transfer of vaccines. For 25, I will leave Henrik Juul, the CFO, to talk a little bit more about the guidance that we're coming out again with a strong financial guidance, with a range of 5.7 to 6.7 billion. We already have secure contracts, which I'll talk to in the coming slides. And again, we're standing by our EBITDA margin projections of 26 to 30%. So again, another strong and exciting year ahead. We turn to the next slide, slide four. So just over a year ago, we had a Capital Markets Day presentation where we tried to inform the market of where Vivera Nordic was heading and to lay out a roadmap in terms of the company's strategy in terms of growth and innovation. And on this slide, we're just running through some of those promises or projections that we made. So in terms of travel health, we said the average growth of the travel health business would be 10 to 12% between 23, 27. We've reported 22% growth last year, and that was on the back of double digit growth the year before. So we're above our expectations for the growth that we see for that business. The tech transfers I already said for rabies and TBE is on track. Rabies is complete. and TDE will be completed this year. So again, on track, also on track to see the improvement in the gross margin for those two products once those tech transfers are complete. Plus, once we've removed all the GSK inventory, so this gross margin improvement of 15% to 20%, should really start to be seen in 26 and the full effect will be seen in 27. So we will remain on track for those improvements in the gross margin. In terms of public, we said our base business will be 1.5 to 2 billion kroner with some spikes. Those spikes could be due to outbreaks or larger one-off orders from different governments. Clearly, The last two years, we've been reporting revenues much higher than the base business, and we're guiding this year, 25, for higher revenues. This is in part due to two outbreaks of MPOCs and a public health emergency, but it is actually also in part due to the growing number of customer, the growing customer base for public preparedness. And as I've said in the past, we may, as we come through 25, have to revisit what that base business truly is, whether it's higher than the 1.5 to 2 billion we projected last year. But we certainly remain on track. In terms of public preparedness, we also talked about launching JINEAS in the US, which was successfully performed last year. And we've already reported strong revenues for the first launch year of 178 million kroner. On pipeline, we said we would come forward with new pipeline assets, and today we're announcing two new pipeline assets, which I'll talk about in the coming slides. But we also said on Chikungunya, which was an asset that we acquired from Emergent BioSolutions, that we would forge ahead with the submissions and approvals of that vaccine. And you will probably all have seen that vaccine is now approved in the US and the EU, and we are gearing up to launch that vaccine in those two territories later this year. So again, all on track or already completed. In terms of the financials, we upgraded our guidance last year and delivered, as I've just reported, within the range. On EBITDA, we've made promises to maintain a 25% to 30% margin, and last year we reported 28%. This year we're guiding between 26% and 30%, so again, living up to the projections that we set ourselves last year. So really a very, very strong performance. We set out some ambitious goals and some ambitious targets just a year ago, many of those are on track to be completed or have already been completed. So really strong performance by the company in 24. So if you go to slide five, a little bit more about the travel health. So we saw a 22% growth in 24 compared to 23, and that primarily was driven by sales of our rabies and TBE. So rabies, we saw grow by 16%. We maintained or grew our market share in the US and Germany, the two key markets. And as I said, we completed the tech transfer on time, on budget, within four years. Rabies is one of the most complicated live vaccines to actually manufacture. And we're incredibly proud of the fact that we were actually able to complete that tech transfer on time and on budget. Regarding TBE, we also saw a strong performance mainly by sales in Europe of 19% increase from the previous year. We saw that we maintained and slightly grew our market share in Germany, and the tech transfer remains fully on track to be completed later this year. In terms of the two new assets, Vaxcora and VivaTiff for cholera and typhoid respectively, we're in a relaunch of these assets, as these were assets that were removed from the market for protracted time during COVID. We are seeing recovery of these two assets. And one of the things that we've realized, particularly regarding the typhoid market, is we have not seen the strong rebound since COVID for typhoid. And in part that's because we and the competitor isn't really addressing one segment of the market, which were prescribers. So the Vaxx, VivaTip was being prescribed previously before COVID, and we haven't been able to address that segment. So this year we'll be focusing on increasing telesales, but also a contracted sales force that hopefully will address that new segment in the typhoid market. Go to the next slide. Public preparedness, again, was really dominated by yet another outbreak of MPOCs, this time primarily in Africa, and we are faced with a new public health emergency. Once again, I'm incredibly proud of Bavaria Nordic's efforts in this space. Within a very short period of time of the public health emergency being declared, we were able to ship and deliver the initial doses of MVA BN to Africa. And our vaccine is now being distributed in a number of African countries, either under an emergency use authorization or the WHO pre-qualification. We also, as I said, launched Jenaeus in the private market in the US, which is a brand new opportunity on the back of the outbreak in 22. And it really is a new opportunity for the access of our vaccine, which is the preferred option in the private space for people at risk of mpox. Later this year, we expect the approval from the FDA of our freeze-dried version, which is a development that was funded by the U.S. government and is near in completion, as I said. The submission was made a year ago. We actually do expect the approval as of late this month. And will fulfill or allow us to hopefully secure more orders with the U.S. government for the freeze-dried version. on top of the existing contract we've had for a number of years. If you go to the next slide, we actually saw strong regulatory progress for our MPOX vaccine last year due to the new outbreak of MPOX. So the indication for NVA-BN was extended to include adolescents based on data from an NIH-sponsored study. We also expanded the approvals in new territories, such as Singapore, New Zealand, and Mexico, on top of the areas where it was already approved. I already mentioned we were the first MPOP vaccine to receive a WHO pre-qualification, which has certainly supported the use of MVABN in Africa, either through the WHO pre-qualification or through emergency use authorization. And on top of that, we've secured funding in collaboration with CEPI for a number of different studies. One is a pediatric study that is rapidly ongoing right now in Africa, which is in children between 2 and 12. This hopefully will expand the label in the coming years to include children. Having said that, under the EUA that have EUAs that have been issued in Africa, children are already being vaccinated. with our products. Other studies that will hopefully expand the indication are also in pregnant and breastfeeding women, which are studies that will be initiated later this year. So really strong progress. It's a testimony to the fact that there is great interest from agencies around the globe and academic institutions to really investigate MVA in new populations which will only benefit the public health should there be a new or continued outbreak of MPOCs. So if we move to the next slide, slide eight. On Chikungunya, we've really seen a fast-moving development. We were able to file both in the EU and the US in parallel last year. We received accelerated reviews in both territories. And the vaccine was approved almost on the record by both in the US and the EU. And in the US, that also came with a priority review voucher, which we have the full intention of selling when the time is right. And we've now been approved in the major territories. We are gearing up for those territories in the first half of this year, and we will continue to follow the new territories such as the UK and other territories in the coming months and years ahead. So we are very confident that we have a differentiated vaccine. We have a vaccine that is half vaccine. We have a vaccine that is not contraindicated. for immune compromised and available for adolescents. So we really believe we have a differentiated vaccine, and we aim to make this the one brand as quickly as possible. We go to the next slide, slide nine. So on our pipeline, we obviously have our chikungunya vaccine, where we, despite the launch, we still have commitments to the regulators to test the vaccine in new populations. So we have a pediatric study that is planned to be initiated later this year. We also have a efficacy study to be conducted if and when there is a new outbreak of chikungunya. So there are still R&D elements of our chikungunya vaccine to complete. However, today we're also announcing the initiation of two new programs, a vaccine candidate for Lyme and also a vaccine candidate for Epstein-Barr virus, both of which we have been working on for a number of years in our R&D facilities. And we've got to the point now where we're ready to move into the clinic. And this year we'll be spending our efforts getting the regulatory approvals and the manufacturing in place to initiate clinical studies So if we go to the next slide, let's talk a little bit about these two new targets. So when we were looking for new clinical targets, we were looking for unmet medical needs, so diseases that were not currently being addressed by vaccines, and both fit into that category. We were also looking for candidates where we believed we had the tools and to address that unmet medical need. And again, both fit into that category. And thirdly, we were looking for indications that had a proven mode of action, meaning that it was known what the vaccine needed to do, what levels of antibodies are required, and for Lyme, that is the case. And if it wasn't a proven mode of action, we were also looking for early signals of proof of concept, either efficacy or meeting a predefined immune level, and both fit into that category. So in terms of Lyme, Lyme is a disease that is spread by ticks, so very complementary to ENCIPOR, tick-borne encephalitis vaccine. It's a bacterial infection transmitted by ticks. There's a high disease burden that is growing as the infected ticks are spreading to more regions around the world. So there's a huge medical need as there's currently no vaccine available. The good news is, as I said, there was a previous Lyme vaccine that was approved and manufactured by GSK. So we understand the mode of action of that vaccine. And that's the mode of action that we'll be following. And it will allow an early readout whether we are meeting the criteria to be efficacious and whether we have areas where we are differentiated from other companies developing a Lyme vaccine. So while we're in the early phases and the lower investment phases of development, we will be able to have an understanding whether we have an efficacious vaccine and whether we have a differentiated vaccine from the competition that are also in development. If you go to the next slide, Epstein-Barr virus is a little different. Epstein-Barr virus is a virus that we will all have been exposed to by the age of 30. Early in life, an EBV infection causes like a flu-like infection with high fever. But later on in life, as an adolescent or a young adult, it can actually cause what is known as infectious mononucleosis, also referred to as glandular fever, also referred to as the kissing disease, because that's the main form of transmission. And while this is a rather nasty infection, it can really cause high fever. and fatigue for prolonged periods of time. Infectious mononucleosis is also being associated with the development of multiple sclerosis later on in life and also is associated with the formation of certain cancers in late life. So there's a huge medical need. A vaccine that could prevent infectious mononucleosis or glandular fever. could have widespread health benefits. Currently, there is no vaccine available. So as I said, it's really an unmet medical need. Now, there was a vaccine candidate for Epstein-Barr virus that has been published based on one of the surface proteins of EBV that was shown to be efficacious in students, university students, So again, there is a path here where after showing safety, we could, while still in the early phases and the lower investment phases of development, have a proof of concept showing that our vaccine candidate is efficacious and potentially is differentiated from other EBV vaccines currently in development. We're very excited about the new candidates. We've been working on them for a number of years, and we really cannot wait to get these candidates into the clinic and see whether these new platform technologies that we've developed are as good as they appear in preclinical studies. So with that, I will hand over the presentation to Henrik.

Thank you very much, Paul. So let's turn to the commercial and financial performance. So we are now on slide 12. So this morning we announced our final and audited financial numbers for 2024. And hereby we also confirmed that these numbers were identical to the preliminary numbers that we announced during the month of February. So no surprise really, but today we can dive into some of the details of the numbers, obviously. So total revenue for the year ended at 5.7 billion Danish kroner. driven by a 3.2 billion Danish kroner revenue from our public preparedness business, which is significantly above the base level that we have talked about previously. And of course, driven by the public health emergency situation that we have on the MPOC side in Africa at the moment. But also fueled by our US private market launch of GENERIS, which we launched last year, and I think already during the first year, we saw revenue of 178 million Danish kroner. On our travel health side of the business, we delivered 22% growth over the previous year and ended with nearly 2.3 billion Danish kroner, with our rabies and TBE products being the high growth products here. with 16 and 19% growth respectively. With that performance, we also triggered last year a sales milestone to GSK of 25 million euros, which we were quite happy to pay as we reached levels of revenue that we had really not anticipated in our original with GSK. So very strong performance by our TBE and Rapius products. Then VivoTiff and Vaxcora, these two products, we still consider being in a relaunch phase. Paul talked a little to some of the initiatives that we are taking to boost the current revenue levels, including hiring contract sales forces to unlock the potential in some segments of the market that has dried out. Worth mentioning here that VexCore, you will see on this table here on page 12, we saw negative revenue in Q4, which is really due to some returns came back. This is something that happens typically when you launch products and you distribute products out in the supply chain and the products unfortunately end where there's too little demand in some corners of the supply chain. So we got some returns in Q4. meaning that we ended up with negative revenue, but still 64 million Danish kroner for the full year on Vaxcora. So significantly above 23 level and not only explained by the full year inclusion of these two products here. So very nice revenue level 5.7, which is in line with the upgraded guidance that we provided to the market last year. If we turn to the next slide here, we see the full P&L. We recognize the revenue level $5.7 billion, gross profit of $2.8 billion, which gives a gross margin of 49%. This probably falls below, you can say, our targeted gross margin level. But it is explained by 2024 being an extremely, extremely busy year with ramping up for MPOC to deal with the current MPOC outbreak, working on tech transfers, both on rapists and TPE, while also developing the manufacturing process for Vimkunja. So it has been a very busy, busy year in the global operations organization, and unfortunately, We were hit by some write-downs on our MVA batches, certain batches not getting released at the end, so we had to write them down. We also had a water damage, unfortunately, on our manufacturing site in Quiskart at some point. And then, of course, the gross margin is also impacted by all the manufacturing activities that went on to prepare us for manufacturing of our chikungunya vaccine, vimkunya. but at stages before you can actually capitalize the products onto your inventory level. But still, I think this was with 49%, we still delivered 1.6 billion in EBITDA, leading to a healthy EBITDA margin of 28%, and in line with our guidance. If we just, before we move on, maybe just a word on R&D. We ended up with 863 million in R&D spends. We had originally, when we guided, said it would be around 850, so very close to what we guided. But here, I think we did include one element that was not anticipated when we guided, and that is the impact of the closure of our San Diego site, which led to approximately 70 million Danish kroner that's included here. And of course, I think that optimization of our R&D organization also leads to some future run rate savings that we have previously valued at between 50 and 75 million Danish kroner per year. The SG&A cost, you can see, is above the 23 level and primarily explained by the fact that we have all the impacts from the acquisition from emergent is included with 12 months in 2024 and only seven and a half months back in 2023. And then, of course, it's also impacted by all the pre-launch activities that we performed during 2024 to secure a good launch preparedness now that we have the approvals here in 2025. So, strong numbers and all in line with the upgraded guidance that we provided in the Turn to the next slide, cash flow and balance sheet. Just draw your attention to a couple of the numbers here. You see the cash flow from operating activities, close to 2 billion Danish kroner, driven by the positive EBITDA, but also a positive contribution from working capital. When we did the original guidance for 24, we actually made an assumption that we would have a negative working capital impact of 900 million. But due to the performance in 24, with particularly high revenue, also in 23, we had a high level of receivables that we cast in during 24. So we have actually turned a negative working capital impact into a positive contribution. due to the reduction in receivables and an improvement in the liability levels as well, offsetting the impact from inventories increasing in line with plans. Cash flow from investments, so that's where we spent the money, and that primarily was driven by paying our milestones to GSK and Emergent. During 24, we paid approximately 1.6 billion, so taking the deferred consideration considerably down, so that we today, we only have approximately 1 billion Danish kroner left to pay to GSK and Emergent. So to the right, you will see our cash position, securities cash and cash equivalents of nearly 2.2 billion, net cash around the same level. And then, as I said, we still owe approximately 1 billion to GSK and to Emergent. The emergent piece, which is 350 million, will all be paid here during the first quarter because they are linked to the approvals in U.S. and Europe. And the milestones to GSK, they will be paid in connection with the completion of the tech transfer of Insapur, and that is 731 million in total milestones outstanding to GSK. On the next slide, Looking a little forward for the remainder of this year, we have, as Paul said, we have guided revenue levels of 5.7 to 6.7 billion Danish kroner and an EBITDA margin of 26 to 30 percent. The public preparedness business, we are guiding 3 to 4 billion, so that's what is creating the interval in the overall revenue guidance. and 2.5 billion of that has already been secured by contracts so this is the second year that we actually guide with an expectation to our public preparedness business and not only with secured contracts and this is of course in anticipation of more orders to come there is still a public health emergency situation declared by who and by africa cdc and there is still an outbreak going on in Africa and a risk that it could spread even further. So more orders are anticipated to deliver between 3 to 4 billion Danish kroner in total. Travel health, we anticipate revenue of approximately 2.5 billion Danish kroner. And for our chicken gunja vaccine, we have included expected revenue of between 50 and 100 million Danish kroner. in our launch year. We have not included any potential income from the sale of our priority review voucher that we earned in connection with the Chikungunya vaccine approval in the US. It will be sold and we are going to sell it as soon as possible, but also at the right price. Other than that, I will just mention here that we have said before we are anticipating the first quarter to be somewhat light both in terms of revenue and EBITDA it is not the high season for our travel health business and it's also driven by the you can say factual timing of the revenue recognition from our public preparedness business so just to expect that the Q1 will be relatively light so I think A great year again ahead of us and with a pipeline with two new exciting assets and a Chikungunya launch and numbers well in line with the promises we made at the Capital Markets Day, I think we are looking forward to another exciting year at the Bavarian Nordic. And with that, I will turn over to the operator and open up for questions and answers.

Thank you. As a reminder, to ask a question, you'll need to press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 and 1 again. Please stand by while we compile the Q&A queue. Our first question comes from the line of Michael Novod from Nordea. Please go ahead. Your line is open.

Thank you very much. Michael Novod from Nordea. A couple of questions, first around sort of potential timing of a new ACIP committee. Can you tell us what you're hearing because obviously there's a lot of noise and a lot of stuff going on in many of the US agencies including FDA, including ACIP panels, etc. So maybe just get an understanding on whether you hear anything around a rescheduling of the ACIP meeting. And then secondly, related to that, the 50 to 100 million Danish kroner for chick sales in 2025, do you think that's doable just by sort of getting off to a good start in, for example, Germany? So maybe you're not that dependent on when this ACIP recommendation comes from the US. And then lastly, anything you hear from the US government with regards to commitment to biodefense going forward, manufacturing in the US, et cetera, it would be appreciated to get some insights whether you hear anything. Thank you very much.

Yeah, thanks, Michael. Yeah, let's see if I can answer these. So ACIP meeting. Yes, the scheduled meeting for the end of Feb was initially postponed and then cancelled. The reasons for the cancellation are public, but we haven't really heard anything. Radio silence, I would say, in terms of when it will be rescheduled. So we're not hearing anything from the working group in the CDC or anything. So I can't add more to that one. In terms of the CHIC launch, despite the ACIP meeting, as we just said, we plan to launch as planned. I'm not trying to say that the ACIP recommendation is not going to have an impact, not having an ACIP recommendation as we anticipated won't have an impact. But we are going to go ahead and launch because a lot of the launch is to do with the disease awareness of healthcare professionals and the like. So we're going ahead and hopefully that will allow us to catch up on the projected sales in the U.S. I would say the one thing about EU since the approval, the relatively recent approval, we have had a lot of requests in Europe asking us when are we launching, when is the vaccine going to be available. That's from a number of KOLs that we're already interacting with through our other travel vaccine franchise. but also some of the other travel clinics that, again, we work with. So there seems to be quite a lot of interest in chikungunya. So it's too early to say, but again, you know, we're excited about the opportunity and what we can do with vinkunya this year. Your last part of the question related to U.S. government and what are we hearing about U.S. manufacturing? I think you indicated it in the question. There's lots of rumors swirling around about all sorts of things. Concrete discussions or concrete facts are a little bit rarer, I would say. So, for example, the discussion about U.S. manufacturing, you know, that's been around for a number of years now. And under the prior administration, it was made pretty clear that what they were talking about was an element of the manufacturing that needed to be in the U.S. And the other thing that was also made clear at that point was most of the slightly barter products would get a waiver as their specialty products and very few manufacturers. Some of the rumors that are going around is that may be different and they're looking for the full manufacturing to be performed in the U.S. And as you know, I think we need to be educating some of the officials that, you know, that may be possible. But if I just take rabies as an example, it just took four years to transfer the drug substance and the filling. So it's not a short endeavor just to move products from one country to another. So I would say we have nothing concrete. on what's going to happen. And I think we just have to wait and see on really what concrete things come through. And then we'll have to respond. But as you know, we have elements of manufacturing already set up in the US. So under certain circumstances and under certain rumors, we would be relatively unimpacted. And under other rumors, we could be more impacted. But they're all rumors.

Yeah. Maybe a follow-up because I guess, and I know you have Grand River, of course, on fill finish in the U.S. I would imagine that also means that you're not that sensitive to potential tariffs or at least not if it's placed on bulk. And how does that actually work? I don't know whether you can comment on it. How does it work with your contract with the U.S. government if there are tariffs imposed? Because who's sort of going to, We're just going to pay the higher price for that.

Yeah. So we have Grand River that does filling for both Junaid, but also chikungunya vaccine. So filling packaging is in the US. So two of our products, as I said, are already available. partially manufactured in the US. So again, depending on what the tariffs, if tariffs come and how they're applied, we may or may not be impacted on some of our products. How it works with the government contract, we would pass through costs that we have to the government.

Perfect.

Thank you very much.

Very clear. Thanks a lot.

Thank you. Once again, to ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. There appear to be no further questions. Oh, just received one question. One moment, please. Our next question comes from the line of Frederick Gomez from Farmium Securities. Please go ahead. Your line is open.

Yes, thank you for taking my questions and congrats for the great numbers in 2024. You may know that there is currently an outbreak on the French territory in La Réunion Island. Authorities are monitoring the number of new cases and new hospitalizations. There are some rumors in France saying that they could buy some vaccine. I'm just curious, are you looking to be part of the contest and maybe to start selling the vaccine for this kind of footbreak? And I'm also curious to get your feedback on, we are lucky because you discussed with us some forecasts for the FACE this year. You mentioned the fact that you need to increase awareness, but don't you think that the best awareness would be Unfortunately, a major outbreak that could spread outside of some territories and come to Europe the way we saw with the monkeypox.

Yeah, thank you.

So what I would say is obviously providing access to a vaccine to people that need it is of a high priority to the company. Since the approval in the EU, we have been in contact with numerous individuals and or agencies and or governments who have reached out to us about the availability of our vaccine and how quickly we could supply. And we're trying, we're in those discussions and addressing those queries. So we'll have to see how that goes. I think in terms of disease awareness, I think there is a couple of things. One, there's a lot of people, well, there's a lot of people in the public who've never even heard of chikungunya or what it is. And of course, we need to raise the awareness to mosquito transmitted disease that they really need to be aware of if they're going to endemic regions. There are also awareness that we have to raise with healthcare professionals either haven't, not that familiar with chikungunya, or even if they are familiar with chikungunya, don't realize the severity of the disease and how serious it really is. So those are two elements that we have been and will continue to work on in the launch phase. And unfortunately, from time to time, we are seeing outbreaks of people bringing back chikungunya in previous years from travel. And that is one of the awarenesses that we need to raise in that it's probably only a matter of time until the mosquitoes, which are actually already present in Europe, can transmit the disease, become infected. So I'm not advocating for an outbreak, but I do believe there are elements that we need to work on and that we will be focusing on. But as I said, we are pleasantly surprised at the high level of interest that we've already encountered since the approval in the EU, which was, what, just a few days ago.

Thank you. There are no further questions.

Okay. Well, thanks, everyone, for joining the call and for the questions. Have a great day. Thank you.