Bavarian Nordic A S

Good day and thank you for standing by. Welcome to the Bavarian Nordic Third Quarterly Report for the nine-month period ended 30th of September 2025 conference call and webcast. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, please press star 1 and 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 and 1 again. Please note that today's conference is being recorded. I would now like to send the conference over to your speaker, Mr. Paul Chaplin, CEO. Please go ahead.

Thank you and hello and welcome everyone to Bavarian Audit's Q3 results. Before I start, I just want to make sure you've seen our forward-looking statements on slide two. On slide three on today's call, you have myself, Paul Chaplin, and I will walk through the key highlights of the first nine months and talk a little bit about the excellent progress that we've made. And then I'll hand over to Henrik Juul, the CFO, who will walk you through the commercial performance and the financials. So if you go to slide four, it really has been a fantastic first nine months of the year. We've recorded close to 4.8 billion kroner in total revenues, which is a 32% increase compared to this time last year, which is a fantastic result and one that is really due to a strong performance across the whole portfolio, both travel health and public preparedness. And that has resulted in an EBITDA margin of 31%. We've had probably the strongest quarter for our travel health business, which is an endorsement of our strategy. And as I'm sure we have many new investors on today's call, I want to just take a few minutes walking you through the graph on the bottom right-hand corner of slide four. This shows the financial performance over the last five years. And before 2020, Bavaria Nordic was really an R&D-focused company. We had our government business, which we now call Public Preparedness, and I'll talk more about that. But essentially, we were a loss-making company coming to our shareholders frequently for capital raises. In 2020, we took the bold step on our growth journey to commercialize the business, and we bought two assets. our rabies and tick-borne encephalitis vaccines, which started our commercial journey. And despite COVID, which obviously had an impact on travel, on travel, on travel vaccines, we were able to grow that business. And in 22, we sold more doses of rabies and TBE than any other previous owner. And that's exactly the strategy that we implemented. We thought that we could purchase what I call unloved assets that weren't performing well in previous owners' hands, and with our dedication and focus, we could turn them around. That's exactly what we've done with Ravies and TBE, and that actually are the golden jewels that are really driving the performance for Travel Health that we have today. In 23, we also added three more assets from... another company which complemented our travel health portfolio. And one of those was a chikungunya vaccine in phase three, which is now approved as vinkunya, which we're launching this year and is also adding not only to the performance in the first nine months of this year, but is a key driver for the future growth. On top of this, we also had our public preparedness business, and I'll talk more about that in the coming slides. But basically, what we've seen over the last five years is a complete transformation of the very Nordic from a loss making R&D focused company to a profitable vaccine company that is having a huge impact on the global stage in terms of public health. Before I move on, I also want to take note, and I'll leave more of the details in terms of the guidance to Henrik later, but we have refined our guidance today, and I just want to address one comment that I've already read, that this is a lowering of our guidance. This is actually not a fact, because at the beginning of the year when we provided the guidance, we had a range for both revenue and EBITDA. This is related to our public preparedness business. And I'll come back to why there's a range, but essentially this is government contract business where you either get a contract or you don't. And therefore we had a range. We refined that range during the year. And today we are recognizing that with one and a half months left, we have secured, we have the business that we've secured, which is 3.1 billion, which means together with travel health and other income, we're at the 6 billion range. While that's at the lower end of the guidance, it is still within guidance. And I would say 3.1 in terms of public preparedness, I have to remind you, is one billion above our normal annual base business of one and a half to two billion. So it's an exceptional year in terms of public preparedness. And we are still standing by our revised and high increased guidance for travel health of 2.75 billion. So very strong first nine months, and I wanna actually take this opportunity to thank all the employees for a tremendous effort. It's really down to their focus and dedication, but time and time again, I'm allowed to talk on a quarterly basis about strong financial performance. Go to slide five on travel health. As I said, it's probably the strongest quarter since we've built up this portfolio. We've seen a 23% increase in sales compared to this time last year. And our two flagships, Rabies and TBE, as I said, these were purchased back in 2020. We've really turned them around. Rabies has gone from strength to strength. We've seen both an improvement in the growth in the market, but also in terms of market share. In the US, we've seen a 4% improvement in market share compared to this time last year. And in Germany, we're really seeing a strong growth, a 53% growth in the first nine months of this year compared to last, which is an outstanding performance. On TBE, again, we have stopped the decline in market share in key markets like Germany since we've bought these assets. And we're actually beginning to now see an improvement in market share, particularly in Germany. So we're incredibly happy with the performance that we're seeing in terms of travel health. And we believe there is future growth in the months and years to come. If you go to slide six, within our portfolio of travel health, we have a vaccine against chikungunya. And chikungunya is a mosquito transmitted disease And until very recently, there were no vaccines or treatments available. The vaccine, our vaccine was part of an acquisition that we acquired in 23 and was approved earlier this year. And subsequently we've launched our chikungunya vaccine, chikungunya, in 10 different countries. So we have had an aggressive launch plan and we've stuck to that schedule. And we're beginning to see an uptake in the sales of the vaccine, which is great to see. And we're on target to meet the 75 million kroner in the first launch year, which is a very strong performance in our first launch year. We filed for further approvals in Canada and with Swiss Medic in Switzerland, and we expect those approvals to be coming next year. And we've already begun some of the post-marketing commitments for expanding the label. And we have a pediatric study and an efficacy study all in progress, which, as I said, are commitments that we've made to the different regulators in the US and Europe. So Chikungunya or Vinconia really represents a future growth potential. Yes, we have to educate and prepare the market, but we believe that this market has the potential to grow to $500 million annually within the next few years, and that's for travel alone. So a great future business opportunity. We turn to the next slide on public preparedness, and I want to spend a little bit of time talking about public preparedness and what it actually is and why it is different to travel health. And the best way of walking you through that is to talk about the revenue graph that's again on the bottom right-hand corner of this slide. And public preparedness is actually one vaccine. It's based on a vaccine against smallpox. Smallpox is a disease that has been eradicated But unfortunately, there is concerns by many governments that smallpox could either reemerge through deliberate release in a bioterrorism attack. It is also closely related to another emerging disease called mpox, formerly known as monkeypox. And we've had a longstanding collaboration with the US government in the development of our vaccine, which is now approved in many countries around the world. And if you look at the graph at the bottom right-hand corner, in 2020, we really had two customers. One major customer, which is the U.S. government, where we've secured more than $2 billion in both development and acquisitions over the years, and Canada. So we had two customers. This changed in 22 when there was the first outbreak of MPOCs, And here we really saw, and you can see a spike in activity in 22 and 23, where we supplied more than 15 million doses of our smallpox and pox vaccine. And coming through that first outbreak, we were left with more customers. So we now had the EU, both HERA, which was a new organization, but also other funding mechanisms in the EU, such as RESC-EU. We had other EU nations like France. So going from two customers to a handful of customers. At that point, we said our base business moving forward would be one and a half to two billion kroner annually. But we would see these spikes from time to time. in revenue due to either future outbreaks of MPOCs or one-off large orders from different governments. Then in 24, we also had another outbreak or a larger sustained outbreak of MPOCs in Africa. And that also led to a continued spike, which has flowed over into 25. So in this year, we are guiding to secure 3.1 billion kroner in revenue, which is, as I said, about a billion higher than our base business is one and a half to two billion. So with public preparedness, it is not as easy to guide accurately in terms of growth or the future revenues simply because it's all down to government contracts. Some government contracts can take many years to negotiate. And unfortunately, I've been involved in government contracts, which we thought were coming through, that fell down at the very last minute. So it is a little bit more unpredictable than a traditional vaccine sales like with Travel Health. But as I've said, we have since 22 been guiding with a base business of one and a half to two billion. But obviously, since 22, we've been recording revenues much higher due to the two spikes that I've explained. In terms of where we are, we are obviously secured contracts of 3.1 billion already this year. We're well on our road to securing. In terms of the first nine months this year, we've exceeded the 2 billion already in the first nine months. And we're well on track to secure the guidance for the rest of the year. We have secured contracts for next year for a total of 1.1 billion kroner. So we're well on our way to securing our base business of 1.5 to 2 billion kroner moving forward. We have ongoing clinical studies that are funded through a collaboration with CEPI, both in a pediatric study, which will hopefully support a label extension to include children in addition to the adolescents and adults that we already have. So if we move on to slide eight, just to talk a little bit about the pipeline, one area is what we call NVA Cell Line. This is actually a trial that was initiated a few weeks ago, and this is moving away from the egg-based production that we currently have to a proprietary cell line that we've developed. The trial that has started is comparing the safety and immunogenicity of the vaccine produced in the different processes. And this is really an initiative that we've taken, which will greatly improve our manufacturing capacity, so that not only could we deal with an MPOPS outbreak, as we have since 22, but we would, with partnerships, also be able to deal with a much larger global outbreak, either of MPOPS or, God forbid, even smallpox. And it also makes us much more robust for any competition that may come later down the road. Other activities in the pipeline relate to Chikungunya. These are post-marketing commitments that we have with the regulators, pediatric study, expanding the label, and also an efficacy study. And other activities are even funded through DOD. or an early stage that is Lyme and EBV, which is still preclinical. And with that, I will hand over the presentation to Henrik Jons.

Thank you very much, Paul. So on slide number nine, just a few more words on the commercial performance for the period. So we delivered for the three borders in Q3 here, we delivered close to 1.8 billion Danish kroner. and that corresponded to an overall revenue growth of 32%. So very significant growth supported by both our business legs, 50% growth on our public preparedness business, and 22% on our travel health business. If we take the public preparedness business, Paul already alluded in detail to this one here. So that has really been about, first of all, securing orders and executing on these orders this year. So targeting the 3.1 billion for the full year. So strong growth on that front for first nine months as well compared to prior year. On travel health, it is really our rapists and our TBE business that has been driving the strong growth. We have seen both for the quarter but also for nine months, 22% overall growth, 23% from our Arabias business, 18% from Insipur. And I think for both products, I think we can say here it's driven by both strong market growths, but also strong brand performance and actually market share gains for both products. So very strong performance. Vimkunja, our new vaccine against Chikungunya, as we launched earlier this year. We are so far very pleased with the performance. We have in very short time managed to launch in 10 countries after the Q3 in the Nordic countries, Italy and Spain as well. So we have in record time, I would say, we have actually made quite a wide launch possible. From the start of the year, we guided on Vinconia 50 to 100 million, and we are now refining that to the midpoint. 75 million, and we have so far delivered 42 after nine months. So going very well and in accordance with our expectations. VivoTiff, our typhoid vaccine, we are on nine months basis, we are seeing a positive growth. We have been struggling somewhat with this product, but we are finally starting to see positive growth. And it's being driven by initiatives taken to gain market share. Unfortunately, the typhoid market has been down by approximately 7% these nine months compared to prior year. But we have actually, year to date, managed to compensate for that market decline by gaining market shares. Third party products at the end. These are the main driver of that one is our Japanese encephalitis product that we have a partnership with the Veneva that comes to an end by the end of this year. And our partnership on hepatitis B vaccine, Hepisop B with Dynavax comes to an end as agreed April next year. So all in all, very strong growth on both parts of our business, 32% for the quarter. and actually the same for the full nine months. So performance that we are very pleased with. On the next slide, we're looking at the full P&L, where we start with the revenue we just talked about, 1.8 billion for the quarter. We have a gross margin of 50%, which is significantly up compared to the same quarter of last year. This is driven by Obviously, the higher volume, the more busy we are in the production area, the more efficient we can be and the easier it is to absorb all the costs to the products being manufactured. But it's also explained by what we call other production costs, which is typically cost. It could be cost of idle capacity. It could be cost of scrap. cost by less efficient yield coming out of manufacturing. So we have been successful in all these parameters, and therefore we are seeing a gross margin of the 50% versus 43% last year. R&D cost varies a little from quarter to quarter. You will see that we are actually spending less than last year, both for the quarter and for the nine months. This is mainly due to timing of some of the committed studies we have on chicken gunya that is progressing. And on sDNA, you see quite a substantial increase. It's mainly or very largely explained by the launch efforts we are putting behind Wim Kunje, the chicken Kunje vaccine, and also by the Nordic entering into new markets. We have, during the last 12 months, established ourselves a commercial presence in a number of countries, including Canada, it's UK, and it's France, which, of course, will give us further opportunities to drive growth going forward. If you look further down the P&L, that gives an EBIT of 1.2 billion nearly. Then we have included in that one other operating income of 810 million, which comes from the sale of the priority review voucher that was recognized in the third corner. Further below, you can see the EBITDA margin excluding the other operating income. That is $515 million, which corresponds to an EBITDA margin before special items of 29%. So on a nine months basis, that takes us to an EBITDA excluding other operating income of nearly $1.5 billion or an EBITDA margin of 31%. So again, strong performance. all in line with what we have communicated previously and in line with our expectations. On the next slide, a quick overview of the cash flow and balance sheet. We saw positive cash flow from operating activities for the nine months, driven, of course, by the positive profit that the business delivered, but also impacted by the proceeds or the income we earned from the sale of the Purchase Review Voucher. Cash flow from investment activities. Here we recognize actually the last milestones that we paid to Emergent BioSolutions and GSK for the acquisitions we did previously. They were recognized here. Not all of them paid yet, though. And then finally, cash flow from financing activities is the sum of the share buyback we did previously in the year and an employee-warrant exercise that was executed as well. So all in all, a net positive cash flow for a period of 500 million approximately. Which obviously improves our cash position, which you can see on the table to the right. We do today have a cash position of close to 3 billion Danish kroner. I have to say here though that our accounts payable are somewhat inflated at the moment as we still owe 70 million to GSK and we also owe royalties on the voucher we sold to NIH and taxes incurred in connection with the voucher. But a strong cash position of close to 3 billion Danish kroner. Then one slide on our outlook here. As we talked about already, we have refined our outlook. We have confirmed The outlook was in the range that was previously communicated. So right now we are looking at a guidance without an interval as we are so close to the year end. We do not operate in an interval for the public preparedness business any longer, but are expecting 3.1 billion. We confirm the upgraded guidance that we issued in connection with Q2 for the travel health business. So that is now 2,750,000,000. And then we have some other income adding up to a total of 6 billion Danish kroner. So a confirmation of all previous guidance, but a refinement now being so close to year end. We are anticipating an EBITDA margin for the full year, excluding the impact from the voucher of 26%, and including the voucher, it will be approximately 40%. The 26% is sensitive to how the the last two months here pans out when it comes to the R&D projects running at the moment, and depending on how they end, there is an upside here that it could be closer to the 27%. But given the current plans, I think we are guiding 26%, and that's most likely where we will end. We have not guided for 26%, obviously, but what we have stated here is that we have previously announced an order to BARDA of 143 million US dollars. Most of that goes into 26. We also announced recently the HERA framework agreement, where there is a commitment of 1.1 million doses, where of 750,000 is impacting next year. So if we add the commitments we have so far, we right now have an order book worth 1.1 billion Danish kroner for 26. And we will, of course, keep communicating to the market when there are material orders being added to this order book. The next slide is simply just a slide we brought to sort of round off the process that we have just been through. I don't want to read off every word here, but basically, there's been a longer process with the takeover attempt on Bavaria Nordic. And we just feel it's important to understand that the company was not for sale. We were approached with an offer, which the board of directors rejected to start with. Later in the process, there was an offer where the board basically judged that now it is at a level where we have to ask the shareholders. The shareholders have voted. The offer did not succeed. So that is the situation. And we, of course, we acknowledge that and we respect that decision by the shareholders. And we remain an independent listed company. and we continue to execute on the growth strategy that was in place even before this process started. I think we are very pleased today to be able to report these numbers here and we are very grateful to our organization who have actually demonstrated that they have maintained a focus on the business while this process has been running. That has been extremely important to us. We have even seen in our engagement surveys that the company or the employees have really stayed engaged in the company. So thanks to the organization for that. Without that, we wouldn't have been able to deliver these fantastic results that we're seeing here today. And in order to make sure that the market is well informed about the strategy that we talk about, we have called for an investor information meeting on December 11 during the morning. More detail will be announced. It will be in Copenhagen. There will be a possibility to attend in person, but it will also be live streamed and recorded. And basically, the agenda will be about giving an update on the business and a recap of our growth strategy. But as I said, more details will follow. We will issue a fresh release once we have the details in place. So with that, I will give the word back to the operator and open up for Q&As.