Bavarian Nordic A S

Good day and thank you for standing by. Welcome to the Bavarian Nordic half-year report Q2 for the six-month period ended 30th of June 2025 conference call. 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, you will need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one and one again. Please be advised that today's conference is being recorded. I will now like to hand the conference over to your speaker today, Rolf Sørensen, Head of Investor Relations. Please go ahead.

Thank you, Operator, and welcome everyone to this, our Q2 update from Premier Nordic. Yes, my name is Rolf Sørensen. from Investor Relations. And in today's conference call, we have, as usual, our CEO, Paul Chaplin, and our CFO, Henrik Juul, that will give the presentation and comments. And after that, we have the Q&A session. And at the end, we will also provide a brief walkthrough of the offer and the process we are looking into. Before we start the presentation, please note that this announcement includes forward-looking statements that involve risks and assurances and other factors, many of which are outside our control, but 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 will hand it over to you, Paul, to start the presentation.

Thanks, Rolf, and welcome everyone to Q2 report for 2025. The focus of today's presentation presentation and talk is really on our first half year results. And while Henrik will give an update at the end on the offer process and the process moving forward, as I said, the focus really is on our financial performance. So if you turn to slide three, we've had a very strong performance in the first six months of this year. We've seen a 33% improvement in revenues compared to this time last year, resulting in an EBITDA margin of 32%. And that's really a result of selling actually 5 million doses of our vaccines across the portfolio. And that's 5 million lives that we've saved in the first half of this year through the sale of our vaccines. We see a balanced growth across the portfolio. On travel health, we've seen a 24% improvement compared to last year, and that's mainly driven by our sales of rabies and TBE, and I'll come back to that more in the next slide. Vinconia has been approved, obviously in the US, Europe, and UK, and we are launching, according to plan, and currently have launched in the US, Germany and France and are on track to meet the guidance for this year. For public preparedness, we've already secured 3.1 billion kroner of contracts. And what that means is that represents at least our base business that we've communicated previously is one and a half to two billion. So this is exceeding our base business and we're on track to deliver that by year end. And with that, and Henrik will go into more details later, we are refining our guidance in terms of the revenue spread, but maintaining our EBITDA margin of 26 to 30%. Also, during the course of this year, we have sold our priority review voucher, resulting in net income of 810 million kroner. And when you take that, into consideration that would improve our EBITDA margin by year end to 40, 42%. So a really, really strong six months, balanced growth across the portfolio, and an exceptional performance by the company. Go to the next slide. So as I mentioned, Travel Health has grown by 24% compared to this time last year. And as you know, we've seen strong growth in this sector quarter on quarter. I want to take a step back, and I know I keep reminding everyone, but I do want to take a step back and remind you of the strategy in that five years ago, we decided to commercialize the business by acquiring assets, assets that didn't have probably the right focus with the previous ownership due to other priorities. And we believe that with a renewed focus from Bavaria Nordic, we would be able to turn these assets around. And here we are again today reporting very strong growth, primarily driven by rabies and TBE, demonstrating that this strategy that we created five years ago is really coming to life and has created a platform that will allow us, as it has already, to acquire other assets. So on rabies, it's a mixture of two different things, either a gain in market share or a growth in the market, depending on the different territories we look at. In the U.S., we've seen a moderate growth in the rabies market of 5%, but we also saw a 7% improvement in our market share. In Germany, we have a very high market share at 97%. but we actually saw a remarkable growth in the first half of this year of 93%. And this growth is due to a number of different things that I'm sure many of you have seen. There are a number of cases being reported in the media of deaths of travelers, which has really raised the profile of the need for a rabies vaccine. And in fact, The demand for rabies and TBE is going from strength to strength. We have already decided to start increasing the manufacturing output for both those vaccines. This is part of the consolidation plan that we had post-tech transfer, but we are accelerating this now due to the high demand that we've seen for both vaccines. On TBE, We have seen a growth in the first half compared to last year. That was primarily due to a strong growth in Q1, which has cooled off a little bit in Q2 due to presumably stocking in Q1, but still a 14% growth overall in the first half of the year. And importantly, we have seen a market share improvement of two percentage points to 30%. I should also mention that the tech transfer of TBE from GSK is now complete. It's been completed on time, on budget. We're just awaiting the normal regulatory approvals, which we expect to receive by year end. So a real success story in terms of our travel health franchise. If you go to the next slide, What we've added to our travel health portfolio is a vaccine against Chikungunya. As I said, it's approved in the EU, US and the UK. And we have launched now in addition to the US, Germany and France with additional launches planned for later this year. We have applied for an approval with Health Canada. We've initiated one of the post-marketing commitments that we have to initiate a pediatric study. And as I mentioned already, we've sold the priority review voucher. Public recommendations are in place in the US and in Germany and the UK. And that's for travelers going to areas where there is a current outbreak or a high risk of outbreaks in the future. And we really believe, so we're on progress to meet the guidance. The launch plan is going according to plan. We are seeing some uptake and interest in the vaccine. And we believe chikungunya will be a key asset to our travel health portfolio in the coming years. If you go to the next slide, this slide almost, demonstrates the issue that we have in that it's a very complicated picture of where chikungunya outbreaks have been seen, whether they're historical outbreaks, current outbreaks. There's differences between the CDC's recognition of outbreaks to the WHO. But the one picture that this says is it's now becoming relatively clear that chikungunya is misunderstood, is not well understood, and is misdiagnosed and underrepresented. It's probably not by coincidence that since vaccines have become available, the number of cases and outbreaks of chikungunya are on the increase. If you go to the next slide, that's also true in Europe. And this is a warning, I think, for all health authorities that now in Europe we're seeing locally transmitted, not for the first case, but probably record number of cases of locally transmitted chikungunya from people, travelers coming back infected and through mosquitoes infecting others. We're close to 30 clusters or outbreaks and more than 120 cases in France and Italy. And as I said, this should be a warning because with global warming, the mosquitoes that can transmit chikungunya are already in Europe and other parts of the world. They're just waiting for the right conditions for the virus to spread. And we're already beginning to see that spread and global warming is probably only gonna increase that threat. If you go to the next slide on public preparedness, We've seen a strong performance in the first half of the year due to sales to numerous governments, but also the supplemental payments from the US government for the freeze-dried doses that we'd already manufactured and will manufacture moving forward. As I said, we've already secured 3.1 billion kroner in contracts. And that will mean, even if we stay at that level, we will outperform our base business quite significantly. We do still see strong demand for our public preparedness business. And we have a number of ongoing studies, even in pediatrics, which we'll be reading out in the coming months, which will allow us, hopefully, to expand our label to include the entire population. Go to the next slide, a little bit on the pipeline. So the first program here on our pipeline slide is what we're calling MVABN Cell Line. This is based on years of work where we've developed a proprietary cell line that would allow us to change the manufacturing process from eggs to a more robust, modern process using cell lines, bioreactors, and standard techniques. That process has been developed. We have been in dialogue with the regulators and we'll be initiating very soon a phase two clinical study, which will show the comparability from a safety immunogenicity point of view of our Mpox vaccine produced in the cell line to the traditional way of producing it in eggs. And this is really, going to increase our capacity and flexibility to manufacture in the future. We currently have a process and capabilities with partnerships and our own capabilities to address an endpox outbreak as we have over the last couple of years. The cell line will allow us to, and I hope this never happens, but will allow us to address a smallpox outbreak globally. We have other programs I mentioned on CHIC Chikungunya, sorry, I should use the right word, Chikungunya vaccine. We have a number of post-market commitments. One we've already initiated with the pediatric study. A second is to demonstrate efficacy, but there, while we're doing all the preparation work, we have to wait for an outbreak in a certain therapy before we perform. And we have a number of other programs in early stage for Lyme and Epstein-Barr virus, which will be moving into the clinic next year. And with that, I will hand over the presentation to Henrik Juel.