Bavarian Nordic A S

Welcome everyone to this Q1 update from Bavaria Nordic on a lovely green day. My name is Rolf Sandsen from Investor Relations and today in this conference call we also have Paul Chapin our CEO and Henrik Juul CFO to give the presentation and comments to all the questions you may have to the session we have as usual afterwards. As you may recall, last time we had some issues for some analyst investors having difficulties getting through with questions. If you realize difficulties getting through, please give me a call or send me a text so I can manage to get your questions to management if it's not possible to get through. But before we start this presentation, please note that this announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside our control, but would cause actual results to differ materially from 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. So with this, I will hand it over to you, Paul, to start the Q1 presentation.

Thanks, Rolf, and welcome everyone to our Q1 earnings. If you turn to slide three, we've obviously had a tremendously strong start to the year. I'll let Henrik talk about the numbers in a few slides time. But basically, we recorded almost 1.4 billion kroner in revenue, representing a 62% growth compared to this time last year. And we've established an EBITDA margin of 31%. So as I said, extremely strong start to the year. And that's due to all parts of the business. So on travel health, We saw a strong start, which I'll go into more details. And on public preparedness, we had originally said it would be a light quarter for our public preparedness due to the back-end loaded nature of the existing orders. We were, however, able, due to a strong manufacturing performance, to bring some orders forward, allowing us to record these strong numbers. And importantly, we've already announced a new order from the U.S. government, which while helps the revenues this year, is really securing good solid revenues for 26. In addition to the strong financial performance, we've also launched a chikungunya vaccine, vinkunya, where it's been approved in the US, Europe, and also in the UK. In terms of the next slide, as I said, the performance of the public preparedness was due to existing orders that we already had in the books. But we were able, as I said, due to the excellent manufacturing performance to bring forward certain deliveries. We have, as I said, secured this order from BARDA for 144 million US dollars. That does allow us to secure or increase the existing contracts on the 2.5 billion kroner to 2.65 billion kroner. So a little bit short of the bottom end of the guidance for the public preparedness this year, but we're still incredibly confident that we will be able to secure new contracts We are currently negotiating a new framework agreement with HERA, and we're also in negotiations with a number of different governments around the world. We continue to manufacture at full scale, meaning that the timing of new orders will be fine in that we have inventory and stock on hand. In addition to the strong performance, we've also had the approval for our freeze-dried version of Jenaeus. That's going to be incredibly important moving forward, as the U.S. government is only going to be stockpiling freeze-dried. That's helped secure the recent order we just announced, but obviously we will, in the coming months, start negotiating for a new contract that will replace the existing contract. If we turn to the next slide, on travel health, we've really seen a strong performance. I will leave it to Henrik to talk really about the various different numbers, but we've seen strong performance for rabies, TBE, and other vaccines such as typhoid. And even within CUNY, we've recorded our first sales rapidly after the approval from the FDA, and actually even before the recommendation from ACIP. What we're seeing in terms of travel health is the market has grown. We've seen strong brand performance in various different areas where we've seen market share gains. This together with some stocking from wholesalers really tells the picture of a very strong performance in Q1. So let's go to the next slide. This is some data from some external data which is predicting that vaccine sales will grow 6% year on year between now and 2030. The interesting thing is when you start looking at the different vaccine sales sectors, it's the travel health that really shows the strongest growth of 20% over the coming years. And I'll get into some of the reasons for that growth. But basically, in travel health, it's more resistant to some of the vaccine skepticism that we see is on the rise. Mainly, this is because people who are seeking vaccination for travel are already convinced about the need for vaccination. And it's also due to a number of new vaccines that are thought or believed that will be introduced in the coming years, including chikungunya. So it's an extremely exciting sector to be in, and one that we actually identified way back in 2020 when we bought the original first couple of assets from GSK. Let's go to the next slide, slide seven. One of the areas that we, that explain this growth in travel health is that for certain vaccines, such as the tick-borne encephalitis vaccine, ENCIPOL, we see an expansion of the endemic regions. So what you're seeing here is a graph of Germany. The red area are areas which are at high risk of the infected ticks. The orange areas are areas that are where ticks infected ticks are being found and are expected to become red or endemic in the years to come. And this is a picture that we also see in Sweden and in other areas of the Nordics and Baltics, is that the endemic region is expanding. Therefore, the growth that we're seeing in TBE is expected to continue as the endemic regions continue to expand. If we go to the next slide, another reason for strong growth in travel health will be the emergence of new vaccines addressing unmet medical needs. And one of these areas is chikungunya. Obviously, vincunya, our chikungunya vaccine, has now been approved by the FDA, but it's also approved in Europe and by the UK. And we've made a filing application to Health Canada. We expect the approval next year. I already said it in the beginning, we've seen some initial sales as we launched in the US very rapidly post the approval, almost a record for the industry, I would say. And we are gearing up for the launch in Europe in the coming weeks. With the approval comes some commitments to the regulators and we will be initiating studies in children and also an efficacy study or a planned efficacy study later this year. And as I said, we are gearing up for launch very, very soon. To go to the next slide, we really feel that Vinconia is well positioned to become the preferred choice for travelers who are potentially at risk of getting chikungunya. The reason for this is, Vinconia is based on a viral-like particle technology, which means that it cannot cause an infection. And so it's designed specifically to be safe, particularly for populations who may have a weakened immune system or the elderly. The data that's been generated for the approval shows a very rapid onset of protection within one week. So these are very, very important in terms of the favorable safety profile, the rapid onset of protection, and the fact that it's in a pre-filled syringe makes it the preferred administration for healthcare professionals. As we launch and are launching the product, our focus is to ensure that we get solid recommendations from the authorities, drive awareness of the dangers of chikungunya, and also to try and promote the benefits of vincunia. If we go to the next slide, talk a little bit about the pipeline. We have a number of programs in our pipeline. One is for converting our manufacturing for mpox, smallpox vaccine away from eggs into a proprietary cell line. This is something that is really innovative. It's going to improve yields, improve our capacity, ensuring that not only can we deal with future Mpox outbreaks, but God forbid that if smallpox was ever re-emerged, we would be able, with partners, to deal with a global pandemic. We have agreed with the FDA a regulatory path. And part of this includes performing a clinical study to show that the product produced in the cell line is the same as the product produced in eggs. And this study will start later this year. On chikungunya, we do have some commitments, as I mentioned. We'll be initiating a pediatric inefficacy study later this year. We have a fully funded program from the US Department of Defense for equine encephalitis. And our two new targets, Lyme and Epstein-Barr virus, are, as planned, gearing up to enter the clinic next year. And with that, I will hand over the presentation to Henrik Juul. Yeah, thank you very much, Paul.

And on the next slide, we will start with a breakdown of the commercial performance for the first quarter. So as already said, fantastic quarter with strong growth of 62%. in total revenue versus prior year, and basically driven by strong performance in both our business segments, public preparedness and our travel health business. Public preparedness, 83% up compared to prior year, driven by executing orders that we secured already last year. And as Paul also said, we had expected on public preparedness a somewhat more light corner, With a lot of efforts from our organization, we managed to pull some of these forward to secure earlier revenue. So very good performance there. Travel Health delivered 52% growth over prior year and mainly driven by our rapist and our TBE businesses that showed extremely strong growth of 53% and 62% respectively. The rapist business was grown basically, again, the market continues to grow. um we have gained market shares in key markets both in the us where we are have gained five percentage points back to 77 percent of the market and in germany we have seen significant growth when comparing to q1 of 24 where there was some supply constraints in some of the european markets and on top of of that significant market growth we have also regained markets here in the german market So we today have 97% of that market. So very strong growth from the grapevius business. On TBE, Paul already alluded to the endemic expansion, and we have really seen the impact of that with a market growth of 17%, pure market growth, and the comparison of apple to apple, really, because we have no supply constraints within this part of the business last year. So very nice market growth. And on top of that, we could add a two percentage point market share gain in our largest market, Germany. So very strong growth there. In Germany, I have to say both our rapist and TV business was slightly impacted by some wholesalers stocking up. Whether that is something that will have a negative impact going forward or not is still to be seen. Typically, wholesalers can also stock up. on a more permanent level when they see there is an uptick in demand in the market. So very, very strong indications, very strong performance from these two products here. VivoTIF Vaxcora remains to be in the relaunch phase, and we're very pleased that we saw the first Vincunia revenue on the list here in the first quarter in record time after we got the approval in the US and even ahead of the ACIP recommendation. we managed to supply into the market and we caught revenue of 5 million, the Danish Krona here. So altogether, 1.3 billion and 47 million in revenue for the first quarter, up 62% compared to prior year. On the next slide, you will see a full profit and loss. And there I will start mentioning, first of all, our Gross margin, we talked about the revenue already. Gross margin of 51%. That is 2% or better than our full year performance last year. And basically, it reflects a more smooth period within manufacturing, where we have seen better yields. We have seen higher success rates, et cetera, which is obviously very good for the margins. R&D costs, slightly lower than last year. and back-end loaded this year. As you will recall, we have guided to spend approximately 900 million Danish kroner this year, so a relatively low first quarter. It's back-end loaded, and most of the project R&D costs will be spent on post-licensure committed trials on Chikungunya. SD&A costs went up from 209 to 250. And it's really driven by the launch of Chikungunya, but also the Bari Nordic expanding into new markets like the UK, Canada, France, and these markets really to support the launch of Chikungunya, but also to support taking back products from our partnership with Maneva. So adding all of this together gives an EBITDA of 420 million Danish kroner or a margin of 31%. So very strong level of profitability in the quarter. Next slide. Just want to use this slide to remind you about what we promised you at the Capital Markets Day last year with regards to the gross market improvements. As you know, we are tech-transferring our two products, the rabies and TBE vaccines from GSK to Bayer and Nordic. And in that process, we are expecting to improve the gross margins. as we take full control, and we will no longer be paying a premium to GSK, and we can harvest some of the process benefits as well. So we are planning a 30% reduction in cost of goods sold on these two vaccines, which eventually will translate into a 15 to 20 percentage point improvement in gross margin. It will come stepwise. We have completed the transfer of the the rabies vaccine already, but we need to floss out the GSK-based inventories before we start seeing a real impact from that. The TBE tech transfer is coming right behind, and we are planning to finalize that over the next few months here. And then the same goes for the TBE vaccine. We need to floss out GSK inventory. So we will start to see some impact late this year from rabies. full impact radius next year then we'll start to see impact from TPE and from 27 we should see a full year impact of this 15 to 20 percentage point improvement in gross market and remember these two products last year together we had a revenue of 1,850,000,000 approximately. So you can do your math and see what those 15 to 20 percentage points mean in terms of overall EBITDA levels. It's a significant contribution to our future profitability as a company. Next slide. A few words on our cash flow and balance sheet for the period. We saw negative cash flow from operating activities. We had a positive net profit, but that was more than offset by an increase in net working capital. and networking capital primarily driven by a reduction in current liabilities as we paid a milestone to GSK that was recorded the previous quarter but not paid, so it ended up being a current liability. Cash flow from investment activities that is mainly consisting of a milestone payment to Emergent Biosolutions, or actually two, of a total of 50 million US dollars related to the approvals by EMA and by FDA of our Wim Cunha vaccine. So you will see all of these milestone payments are going through the system as we speak right now. To the right, securities, cash and cash equivalent, you will see we have right now approximately 1.2 billion Danish kroner. We still owe GSK the last milestones related to the finalization of the transfer of the TBE vaccine. And in total, we owe them approximately 739 million Danish kroner. We also have an amount still not paid included in current liabilities of 20 million U.S. dollars to Emergent BioSolutions. But as you will see on this page here, we have sufficient cash to honor those commitments that will take place over the next few months as we finalize the tech transfer. On the next slide, I just want to remind you on that one that we are reiterating or confirming our full year guidance for the year, so we are still expecting revenue between 5.7 and 6.7 billion Danish kroner and expect to end the year with an EBITDA margin between 26 and 30 percent. I will on this slide here just highlight, and you can see here that now The level of secured orders in our public preparedness business now stands at 2,650,000,000, as there was 150,000,000 Danish kroner impact from the recently announced option that was exercised by BARDA. So, a contribution to 25, but primarily securing the business for 26 from that order. I would also like to highlight on this slide here as well, as you will have seen, the US dollar, has depreciated in value against Euro and Danish kroner over the last period here. And when we did the guidance, we assumed a level of seven Danish kroner per US dollar. Right now it's around 6.6, so it has declined. But we have hedged all known exposure in US dollar, so therefore it should have no material impact on our guidance for this year. So with that, I'll just end up saying great start of the year. We can confirm the guidance. I think we have made some very important company announcements recently, particularly on our tic and conga regulatory process, but also securing business with the US government. Some for this year, but also for next year. So with that, I will open up for Q&A. So operator, please open for Q&As.

Thank you. As a reminder to ask a question, please 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. Once again, please press star one and one and wait for your name to be announced. And one again. We are now going to proceed with our first question. The questions come from the line of Thomas Powers from SCB. Please ask your question.

Yes, thank you very much. A couple of questions from my side here. So first of all, on EBITDA, so you deliver 31% for the quarter. You have some R&D costs, tailwinds, of course, but when adjusting for that, maybe 27-28%, as far as I can calculate. But then you also have negative product mix impact, of course, travel being impacted by the tax transfer. So what am I missing here in order to stay within your current 26 to 30 percent guidance range? And then the second question, can you maybe just add a bit of color on travel health growth outlook for the year? You keep the 2.5 billion target or some 10 percent year-over-year growth. So you're sort of implying a negative quarter or quarter growth going forward. Is there any constraints, supply constraints, anything we should be aware of? Any changes to seasonality maybe? We also saw that last year with a very strong Q1 for TBE, but now even stronger, of course. So is there anything also saying that we should be maybe a little more cautious about Q2 or maybe even potentially also for the fourth quarter in terms of seasonality. And then just lastly, squeezing in just a question on Kenya. So any comments on this initial feedback and also primarily thinking on your competitor with the safety concerns out there? So we know that they had a quite large order to the French authorities. So anything here that concerns potentially could lead you to take over that order maybe or anything maybe upside to 50 to 100 million targets for this year. Thank you.

Yeah, so thank you, Thomas, for the questions. I think first of all on EBITDA, we delivered 31%. We have guided 26 to 30, so you can see the upper end of what we have guided. It's not far from what we're showing this quarter actually. But It has been a very good quarter for us in several aspects. I already talked about the gross margin. We saw a smooth quarter. We are manufacturing biologics, remember, so there can be variations between quarters on actually what gross margin you can deliver and how successful you are in your manufacturing. We do believe we are entering a period with more routine manufacturing after a very hectic 24 with the two tech transfers and ramp up. within manufacturing. So hopefully we can maintain that good trend. That will definitely help. And then you mentioned it also, the R&D is back and loaded. So I don't think you're missing anything really in your calculations. But we have, as you know, we have guided 26 to 30%. So what we deliver in the first quarter is close to the upper end of that. Maybe I can continue on travel health, the next question. So I think you're alluding a little to, we had a fantastic first quarter and we're still sticking to two and a half billion for the full year. I think our take on that one is these vaccines are pretty seasonal, but the seasons, they are not exactly the same every year. We saw that last year with a very strong TBE Q1 performance. So I think we are just taking somewhat cautious approach this time. We want to see the next couple of months. Hopefully, they continue along the same trends. But to your questions, we do not see any supply constraints at the moment, and we have no concerns. It is simply just a cautious approach that we're taking. We want to see a couple of months more before we revisit our expectations for the full year. Then you had a question on Vilcunia. Maybe that's one for you, Paul.

Yeah, so you're right. There's been, unfortunately, some safety issues with the competitive product, and that's led to EMA suspending the use of that product in people 65 years and older. We have not currently launched VinCunia in Europe. So, unfortunately, we were not in a position where we could supply product to the French authorities. We are, of course, in dialogue with the French authorities. And as I said in the presentation, we'll be launching in the coming weeks in Europe. We're certainly not thinking of changing the guidance that we have for this year. But of course, outbreaks of chikungunya will only help in the sales. And the other thing I would say of interest is that since there have been now two chikungunya vaccines available, the cases of chikungunya globally are increasing and sporadic, more sporadic outbreaks have been reported. And I think that only just goes to show that the cases of chikungunya have been underrepresented historically. And there's a lot more disease that people are now picking up. So I think it bodes extremely well for the launch of Vinconia. But for now, we'll keep the guidance as it is, and we'll see how that launch goes in the coming weeks. That's great. Thank you very much.

Thank you. As a reminder to ask a question, please press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. Thank you. We are now going to proceed with our next question. The questions come from the line of Benjamin Jackson from Jefferies. Please ask your question.

Hi, team. Thank you very much. It's Benjamin Jackson at Jefferies. Just two quick questions, slightly higher level than those latter three. I'm thinking more So firstly, on obviously potential exposure to tariffs as you're thinking around this changed with regards to the last time we spoke and call up on that. And is there any potential strategies you're having to think about there to hedge that exposure? And then secondly, interesting to know if you have noticed any kind of change in dialogue or commentary with the discussions you're having with regards to US organizations Obviously, there have been a couple of changes in the FDA specifically focused around here on vaccines and also commentary about how vaccine trials may change. So specifically, I am looking and thinking, have you had to change your strategy or thinking about, one, the early stage R&D that you're conducting and how you're planning to conduct it? And two, are there any changes in thinking about how you're having to approach the post-approval process in the R&D sense? Any ideas around that would be great. Thank you.

Yeah, so I'll answer it backwards. So I'll take the first one. So in terms of our interactions with the US government, so if I just take BARDA first, really we've seen no impact of anything. It is business as usual. You saw that we've obviously secured the latest option or order for the freeze-dried that actually occurred a little earlier than we'd originally planned and was flawless to be quite frank in terms of the execution. So in terms of the public preparedness business, it seems to be business as usual from our side currently at least. In terms of FDA, I think it's important to note that nothing has really changed i mean obviously the head of siever has just been appointed but in terms of policies and regulations they haven't changed there's a lot of speculation a lot of rumors that things may change but nothing has currently changed so the the thing if you look at our pipeline we're still at the very early stage going into uh phase one. So I don't think any, even if any changes occur in terms of placebo efficacy trials being required, that's typically the standard anyway. I don't think anything has really impacted to make us change in terms of the development or anything like that. But as I said, we have to wait and see how things develop. And that actually is also the answer to the tariff question, because how do you prepare for something that hasn't occurred? And we don't know whether it will occur or at what level it will occur. I think if you look at our manufacturing setup, some of our manufacturing is already in the US. So I think the impact of tariffs in the US may not be as big an impact for BN as a lot of people are speculating. But again, I think at the end of the day, we have to wait and see what happens. And then we will obviously be able to deal with the situation. I don't know, Henrik, if you've got anything more on Terrace.

No, you're absolutely right. I think we are sort of spending the waiting time, if you can call it that, preparing ourselves, analysing scenarios, and have reached the conclusion that we do not expect this to be dramatic in any way for Borough of Nordic, and we have a list of potential mitigating actions and strategies we can take to mitigate a potential situation.

Very clear. Thank you very much.

Thank you. We are now going to proceed with our next question. The next questions come from the line of Jesper Ilse from Carnegie. Please ask your question.

Thank you so much. I have three. So first off, continuing on the topic of travel health sales, very strong underlying momentum. Of course, there's also been some easy comparisons, some wholesale stocking you pointed out, and I also understand some price increases. My question is basically just perhaps you can split the very strong growth this quarter into the different components just to help us understand how we should extrapolate it and sort of if this is a new higher base or basically a new growth rate. That's the first question. Second question, you still have this priority review voucher. I just wanted to understand the process from here and update. So have you started a process reaching out to companies to sell it? And if not, what is basically holding you back? And can you just also address whether you intend to send that cash from the TRV back to shareholders? And then last one is basically more a household question on the topic of tax. which may be a boring topic, but you still have this non-recognized tax asset. Can you just remind us about the size of this tax asset and how you intend to use it because you still do not pay that high tax rates? Thanks so much.

Do you want to have a stab at the first and the last one? The tax, I definitely think it's you. I thought that was one for you.

Okay, thanks, Jesper. First of all, on travel health, You said it was an easy comparison. I don't think we see it as an easy comparison. Yes, there has been a few price adjustments, but they are not easy. I think you implement them when you can and when competition allows it in the markets. And then there has been a little, I would say, wholesaler stocking. But the thing with wholesaler stocking is there's not sort of a report you can pull out and say wholesaler stocking was at this level, X million euros. You can do some analysis that is not perfect. You can look at what are you selling into the market? What is the market pulling out of the pharmacies and other channels and see if there are mismatch between these, which can indicate some wholesaler stocking. And what does wholesaler stocking then means? I think if it's a temporary phenomenon, it will hit you again in the coming months as they will not replenish the inventory. But if it's really driven by an underlying strong demand, I think it is just the wholesalers reacting to that situation. They typically want to have X number of days of the projected demand on stocks. I think it's also too early to say whether this stocking is temporary or permanent, new level. I think what is important to see, I think that is the underlying growth that we see. Take TPE, Germany, 17% growth driven by the endemic expansion. And as Paul alluded to previously also, we do see the whole travel health segment outperforming the general vaccine space. And with some analysis suggesting even up to 20% growth over the next five years. So I think key messages on travel health for this quarter is continued growth on the radius business, no supply constraints. That's what you see the impact in this quarter here again. market share gains both in Germany and the U.S. on the rapist business and on TPE strong underlying demand growth and again also a market share gain of up to the nearly two percentage point so very strong growth and on the tax it is correct that we have non-recognized assets created as accumulated losses over the time The number is quoted in our annual report. I don't want to give you an approximate number, but you can find it in the annual report, how much it is, which we can use going forward. There's no expiry date on this, so it will help us. You cannot use it 100% every year. I believe you can use it up to 60% in a year to offset against your income. But the specific number... Rather than giving you some approximate number, I would suggest you look it up in the annual report or I can send it to you afterwards, Jesper. And then the final thing on the PRV, yes, correct, we have not sold it yet. We are not in a rush to sell it. I've shown you the cash flow. We don't need it, so we want to make sure it's sold at the right price. There is interest out there. We have had some inbound calls, but we haven't sold it yet and we are We will sell it at the right time when we find the buyer who's willing to pay the right price.

Okay. Thank you so much. Thank you.

Thank you. We have no further questions at this time. I will hand back to you for closing remarks.

Thank you. Well, thank you, everyone, for attending, for the questions, and have a great day. Goodbye.